Externally sponsored scientific research

Brand /
Substance

Mechanism
of action

ESR - Areas of interest

AZD1656

Make a submission

Glucokinase (GK; hexokinase 4) activator

• Preclinical reprotoxicology data are available and have not identified any specific risks. Women of child-bearing potential using highly effective contraception can be included
• Proposed indications should be evaluated against the risk of hypoglycaemia in non-diabetic subjects

AZD4017

Make a submission

11-beta-hydroxysteroid dehydrogenase type 1 (11ß-HSD1) inhibitor

• Preclinical reprotoxicology data is not available for this compound. The inclusion of women of child-bearing potential using highly effective contraception in trials of modest size and duration could be considered based on the risk benefit and in accordance with territory specific requirements
• Preclinical safety studies support future clinical studies of up to 3 months duration with the need for monitoring liver enzymes, thyroid, and adrenal function

Brilinta /
Brilique’s (ticagrelor)

Make a submission

ADP receptor antagonist

• Brilinta/Brilique in CAD-PMI, CAD-T2DM and AIS (acute ischemic stroke).

Bydureon
(exenatide)

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GLP-1 receptor agonist

Study proposals with Bydureon intended to investigate:

• Comparison with basal insulin or delay of insulin initiation
• Bydureon autoinjector device ease-of-use and patient acceptability (not placebo-controlled)
• Administration in sequential combination with SGLT-2 inhibitors
• Effects on cardiometabolic parameters

Crestor (rosuvastatin)

Make a submission

Selective and competitive inhibitor of HMG-CoA reductase

• Pilot studies in novel indications
• Studies of lipid efficacy biomarkers or other novel intermediate endpoints
• Atherosclerosis studies of niche patient populations; exploratory studies of plaque stability and composition
• Studies of pleiotropic effects, including studies of patients with a non-CV disease state

Forxiga / Farxiga
(dapagliflozin))

Make a submission

SGLT2 inhibitor

Original studies, involving Dapagliflozin, aimed to:

• Define its clinical benefit within different therapeutic strategies, alone or in combinations with other medications, addressing multiple populations in type 2 diabetes mellitus, including other comorbidities or disease areas (e.g. overweight/obesity, heart failure, chronic kidney disease)
• Better understand the mechanism of action on different target organs
• Effects on cardiovascular risk factors and on renal impairment

Research proposals can be non-clinical, clinical interventional and observational
 

Investigators should justify the innovative contribution of their research proposal and avoid repetition of previous well-established research.

Plendil

(Felodipine)

calcium antagonist

• Medical areas related to hypertension

Accepting proposals in China only (previous confirmation with Xi Zang Kang Zhe Pharmaceutical development Co., Ltd.) 

Sodium Zirconium Cyclosilicate (SZC)

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Oral, non-absorbed potassium binder

• Real World Evidence, with local data generation on SZC use, Quality of Life studies and resource utilization impact
• Until Lokelma is authorised in the country of the applicant, we need to defer the endorsement of any clinical proposals. Areas of interest will be:
  • SZC in Chronic Kidney disease (CKD): Efficacy >28d in CKD; enabling RAASi use in CKD; SZC use in dialysis; impact on nutrition; patient reported outcomes; use to facilitate fistula maturation in dialysis.
  • SZC in Heart Failure (HF): Efficacy >28d in HF; SZC enabling RAASi/Entresto/MRA use in HF; 
  • SZC in ER setting and resistant HT
  • Other: Adherence and persistence; Frequency and K monitoring and treatment protocol; Endpoints other than K; Impact on blood pressure.
• HiK management: Association between Hyperkalemia (HK) and CKD progression; readmission rates in HK; K variability; HK in the ER setting; arrhythmias in CKD. 
• Profile/Mechanism of Action: Benefits of selective K trapping; benefits of increased bicarbonate with SZC.

Renal disease (no substance or brand involved) 

Make a submission

NA

• Research to further development of regulatory endpoints in renal trials
• Research to support understanding of early disease progression, and how it relates to progression of disease
• Research to support understanding of fast progressors versus patients with slower prognoses
• Mechanistic and biomarker studies to further novel segmentation of chronic kidney disease, which is not biopsy dependent

Lesogaberan /
AZD3355

Make a submission

Gamma-aminobutyric
acid receptor B (GABAB) agonist

• Preclinical reprotoxicology data is available and has not identified any specific risks. Women of child-bearing potential using highly effective contraception can be included
• Due to the previously observed increases in liver enzymes, proposals should be for diseases that require short term dosing regimens with appropriate liver monitoring and exclusion of patients or volunteers with liver abnormalities, or alternatively for diseases of severe unmet medical need where a case for tolerating potential adverse events can be made

Nexium (esomeprazole)

Make a submission

PPI inhibitor

• Proposals for ESR will not be endorsed, unless if a major data gap has been identified
• Accepting proposals in Japan and China only

Brand /
Substance

Mechanism
of action

ESR - Areas of interest

Fluenz Tetra /

FluMist

Quadrivalent

(LAIV/QLAIV)

Make a submission

Live attenuated influenza vaccine

• Sustainability of school-located influenza vaccination programs
• Novel approaches to evaluating LAIV-induced immune responses

Synagis
(palivizumab)

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IgG1κ

• Burden of RSV disease due to comorbidities and/or socioeconomic status
• Healthcare utilization following RSV LRI
• Exploring challenges in compliance and adherence associated with dosing of RSV prophylaxis
• Cost of premature birth hospitalizations
• Long-term consequences in preterm infants, children with CLDP and children with hemodynamically significant CHD

Brand /
Substance

Mechanism
of action

ESR - Areas of interest

AZD0328

Make a submission

Nicotinic acetylcholine

receptor alpha 7

(a7 nAChR) agonist

• The reproductive toxicology package indicates a risk of fetal toxicity. The inclusion of women of child-bearing potential would need to be assessed for any proposal based on the risk-benefit and the use of appropriate highly effective contraception
• AZD0328 is renally cleared and, therefore, future studies will require an assessment of the risk-benefit for subjects with renal impairment

AZD6765 (Lanicemine)

Make a submission

N-methyl-D-aspartate (NMDA) receptor, low-trapping, open-channel blocker

• Preclinical 3, 6 and 9 month intermittent i.v. infusion studies have been performed to support > 45 infusions in humans. NMDA-class associated neurotoxicity findings have been observed in rats at supra-therapeutic doses
• The reproductive toxicology package indicates a risk of fetal toxicity. The inclusion of women of child-bearing potential would need to be assessed for any proposal based on the risk-benefit and the use of appropriate highly effective contraception
• Proposals for indications, other than the original target indication of Depressive Disorders are welcomed. Proposals should be supported by a strong scientific rationale and/or supporting preclinical data

AZD7325

Make a submission

Gamma-aminobutyric

acid receptor A alpha 2 & 3

(GABAAa2,3)

positive modulator ;

• Preclinical reprotoxicology data is available and has not identified any specific risks. Women of child-bearing potential using highly effective contraception can be included
• Subjects with past or present symptoms of alcohol or drug abuse/dependence and/or subjects suspected of abusing alcohol or illicit or prescription medications should probably be excluded

Cabocaine
(mepivacaine)

Make a submission

Mechanism of action not fully understood

• No additional indications are being sought for Cabocaine
• Proposals for safe and appropriate use of Cabocaine within currently approved indications may still be supported, if a major data gap has been identified

Citanest
(prilocaine)

Make a submission

Mechanism of action not fully understood

• No additional indications are being sought for Citanest
• Proposals for safe and appropriate use of Citanest within currently approved indications may still be supported, if a major data gap has been identified

Diprivan
(propofol)

Make a submission

Mechanism of action not fully understood

• No additional indications are being sought for Diprivan
• Proposals for safe and appropriate use of Diprivan within currently approved indications may still be supported, if a major data gap has been identified

EMLA
(lidocaine /
prilocaine)

Make a submission

Mechanism of action not fully understood

• No additional indications are being sought for EMLA
• Proposals for safe and appropriate use of EMLA within currently approved indications may still be supported, if a major data gap has been identified

Marcaine
(bupivacaine)

Make a submission

Mechanism of action not fully understood

• No additional indications are being sought for Marcaine
• Proposals for safe and appropriate use of Marcaine within currently approved indications may still be supported, if a major data gap has been identified

Movantik/Moventig (Naloxegol/NKTR-118)

Make a submission

Oral peripherally-acting mu opioid receptor antagonist

• Proposals that increase the knowledge of Movantik’s/Moventig’s efficacy and safety in OIC patients with chronic pain (non-cancer and cancer)
• Proposals that assess efficacy and safety of Movantik/Moventig in novel areas: eg OIC in acute pain, prophylaxis of OIC, other GI disorders
• Proposals that contribute to the understanding of Movantik’s/Moventig’s mechanism of action

Naropin
(ropivacaine)

Make a submission

Mechanism of action not fully understood

• No additional indications are being sought for Naropin
• Proposals for safe and appropriate use of Naropin within currently approved indications may still be supported, if a major data gap has been identified

Seroquel /
Seroquel
XR (quetiapine
fumarate)

Make a submission

Mechanism of action not fully understood

• No additional indications are being sought for Seroquel/Seroquel XR
• Proposals for safe and appropriate use of Seroquel/Seroquel XR within currently approved indications may still be supported, if a major data gap has been identified

Vimovo
(naproxen /
esomeprazole)

Make a submission

NSAID/
PPI

• No additional indications are being sought for Vimovo
• Proposals for safe and appropriate use of Vimovo within currently approved indications may still be supported, if a major data gap has been identified

Xylocaine
(lidocaine)

Make a submission

Mechanism of action not fully understood

• No additional indications are being sought for Xylocaine
• Proposals for safe and appropriate use of Xylocaine within currently approved indications may still be supported, if a major data gap has been identified

Zomig
(zolmitriptan)

Make a submission

Serotonin receptor (1b,1d) agonist

• No additional indications are being sought for Zomig
• Proposals for safe and appropriate use of Zomig within currently approved indications may still be supported, if a major data gap has been identified

Brand / Substance

Mechanism of action

ESR - Areas of interest

Acalabrutinib

Make a submission

Highly selective, potent BTK inhibitor

Proposals evaluating the use of acalabrutinib in B-cell hematological malignancies

• Novel combination approaches with acalabrutinib will be considered.  In particular, concepts that address an important scientific question and could be relevant across a range of B-cell diseases
• Evaluation of surrogate marker endpoints predictive of long-term outcomes with acalabrutinib treatment
• Data generation specific to regional needs where the standard of care may differ
• Evaluation of treatment duration, including the addition of other therapeutic agents to assess the clinical benefit of continuing acalabrutinib beyond initial progression
• Assessments of real world data, including comparison with other novel agents
• Studies evaluating the role of maintenance therapy with acalabrutinib
• Proposals will be prioritized accordingly based on scientific merit and fit with the clinical program.

AZD1775

Make a submission

Wee-kinase Inhibitor

• Proposals will be prioritised accordingly based on scientific merit and fit with the core development programme
• Collaborators may need to generate additional preclinical work to support clinical settings of interest

AZD4547

Make a submission

FGFR1, 2, 3 Inhibitor

Accepting Externally Sponsored Research Proposals on a drug only basis at this time

AZD5363

Make a submission

AKT Inhibitor

Accepting Externally Sponsored Research Proposals on a drug only basis at this time

AZD6738

Make a submission

ATR Inhibitor

• Head & neck cancer
• Gastric cancer
• Colorectal cancer
• Chemotherapy combinations
• Combinations with other novel agents
• Proposals should be supported by a strong scientific rationale and preclinical data package, or proposals to generate such data

AZD8186

Make a submission

Lipid kinase PI3Kß /d

Not accepting Externally Sponsored Clinical Research Proposals.

AZD9150

Make a submission

STAT3rx antisense oligonucleotide

• Proposals will be prioritised accordingly based on scientific merit and fit with the core development programme
• Collaborators may need to generate additional preclinical work to support clinical settings of interest

Cediranib / AZD2171

Make a submission

Oral VEGF receptor -1-2-3 kinase inhibitor

•  As a combination with novel agents for which there is a strong scientific rationale and demonstrable pre-clinical evidence or translational science, with a preference to combining with existing AZ marketed or pipeline products.
• Monotherapy proposals must have an exceptionally strong rationale to be supported by AZ.

Durvalumab / MEDI4736

Make a submission

Immuno-modulator; a human mAb of the immunoglobulin G1 kappa (IgG1κ) subclass that inhibits binding of Programmed Death Ligand 1 (PD-L1) to PD-1 and CD80

• NSCLC
  • Durvalumab +/- tremelimumab in NSCLC patients excluded from the registration program (un-resectable Stage IIIA / IIIB and Stage IV)
  • Durvalumab-based combinations in immunotherapy pre-treated patients
  • Durvalumab +/- tremelimumab combinations with chemotherapy, radiotherapy or other agents (immunotherapy / targeted therapies)
  • Enhance biomarker knowledge to support clinical decision making for durvalumab-based combinations
  • Early predictors of clinical activity and immune-related adverse events
  • Patient reported outcomes and patient experience of patients receiving durvalumab +/- tremelimumab in NSCLC
• Urothelial Cancer
  • Durvalumab +/- tremelimumab combined with SoC chemotherapy in front-line metastatic urothelial cancer
  • Durvalumab +/- tremelimumab combined with novel agents or radiotherapy in front-line or relapsed bladder cancer
  • Optimal utilization of Durvalumab +/- tremelimumab in non-muscle invasive bladder cancer
  • Durvalumab +/- tremelimumab combined with SoC chemotherapy, novel agents, or radiotherapy in patients with stage II– IV non-metastatic disease
  • Real-world evidence (RWE) on treatment patterns and outcomes with introduction of checkpoint inhibitors in bladder cancer
  • Prognostic value of PD-L1 expression in patients with bladder cancer treated with the SOC
  • Patient reported outcomes and patient experience of patients receiving durvalumab +/- tremelimumab in bladder cancer
• Head & Neck Cancer
  • Durvalumab +/- tremelimumab in HNSCC patients excluded from the registration programs
  • Durvalumab +/- tremelimumab in locally advanced HNSCC sub-populations
  • Durvalumab +/- tremelimumab combined with targeted agents (e.g. cetuximab, AZ targeted small molecules etc.), radiotherapy and/or chemotherapy
  • Patient reported outcomes and patient experience of patients receiving durvalumab +/- tremelimumab in HNSCC
  • Generate data in historical recurrent/metastatic HNSCC cohorts based on biomarkers and current SoCs
• Other indications (e.g. SCLC, GI tumours) supported by robust preclinical data may be considered
  • Priority will be given to proposals that advance understanding of core development programs in NSCLC, Bladder and HNSCC
  • Pre-Clinical studies will be considered through the ESR program
  • Studies that overlap or compete with AstraZeneca development program or where there is compromised or excessive safety risk will not be accepted
  • Non-oncology indications will not be supported at this time
    

Faslodex (fulvestrant)

Make a submission

Selective Estrogen Receptor Downregulator

Opportunities for development in Breast cancer:

Monotherapy studies:

• In early stage breast cancer
• First-line for patients with advanced breast cancer after adjuvant AI

Combinations studies with targeted biological agents:

• In early breast cancer
• Adding novel targeted agents after progression on Faslodex

ER+ subgroups:

• Peri- and pre-menopausal women as monotherapy or in combination (e.g. with GNRH agonists, novel targeted agents)
• Patients with ER mutations
• Patients with visceral disease
• Patients with different molecular pheonotypes (e.g Luminal B breast cancer)

Iressa (gefitinib)

Make a submission

EGFR Inhibitor

• 1st line EGFR mutation positive advanced NSCLC, e.g. combinations
• 2nd line onward EGFR mutation positive NSCLC, e.g. re-challenge therapy
• Neo-adjuvant & Adjuvant EGFR mutation positive early and locally advanced NSCLC
• All lines NSCLC diagnostic research
• Non-NSCLC tumour settings which are EGFR M+ve

Lynparza
(olaparib)

Make a submission

PARP Inhibitor

• Studies in ovarian cancer patients with sBRCA or non-BRCA HRD mutations, examining prevalence, diagnostics, molecular profiles; or clinical outcomes following treatment with Lynparza
• Pre-clinical to proof of concept scale clinical studies of combination of Lynparza with targeted small molecules or Immunotherapy, in BRCA+ve patients
• gBRCAm, sBRCAm & HRRm studies as monotherapy or in combination with other products in breast cancer patients
• Exploring effective diagnostic screening strategies to identify BRCAm & HRRm/HRD patient cohorts
• Studies in prostate cancer patients with BRCAm/HRRm, examining prevalence, diagnostics, molecular profiles; or clinical outcomes following treatment with Lynparza
• Combination studies with currently approved therapies in prostate cancer, including targeting of specific patient groups by molecular signature
• Patient reported outcomes and patient preference studies
• Studies examining switching from or substituting olaparib for bevacizumab in ovarian cancer patients
• Studies in other tumours with DDR involvement
• Other studies for which a strong scientific rationale and/or supporting pre-clinical data can be provided
• PLEASE NOTE THAT ASTRAZENECA IS UNABLE TO REVIEW PROPOSALS FOR STUDIES INVOLVING PEMBROLIZUMAB AND LYNPARZA. IF YOUR IDEA INVOLVES THE USE OF PEMROLIZUMAB, THEN PLEASE SUBMIT YOUR APPLICATION TO MERCK, WHO ARE RESPONSIBLE FOR THIS COMBINATION.

MEDI551

Make a submission

MAb
Anti-CD19 B cell depleting agent

Accepting Externally Sponsored Clinical Research Proposals  for drug only in allogenic stem cell transplantation

Osimertinib / AZD9291

Make a submission

EGFR sensitising and T790M Resistance Mutations Inhibitor

2^nd Line post-TKI T790M osimertinib segment and 3L post-osimertinib progression  

• Improving benefit for patients refractory to osimertinib e.g. understanding innate resistance biology, prognostic strategies, treatment approaches
• Extending benefit to patients who progress post osimertinib treatment e.g. understanding genomic and non-genomic acquired resistance biology, treatment strategies
• Use of combination strategies to prolong benefit of osimertinib e.g. strategies to intervene at asymptomatic progression, excluding anti-VEGFR related combinations
• Building biology of T790M disease heterogeneity e.g. complex EGFR mutant context, co-existing genetic drivers
•  Increasing our understanding of intracranial resistance

2^nd line post-TKI treatment of T790M unknown/negative patients

• Understanding molecular characterisation of T790M-ve segment and treatment opportunities (excluding cMET-targeted treatment)

1^st line Treatment with Osimertinib

• Defining future landscape of 1L acquired resistance to osimertinib and treatment options e.g. genomic and non-genomic mechanisms, CNS resistance
• Identifying combination strategies to improve benefit in refractory population
• Use of combination approaches to intervene at asymptomatic progression
• Characterising sub-populations e.g. rare activating mutations, sensitive detection of T790M
• Understanding CNS disease e.g. treatment outcomes, combination options to treat refractory disease, impact of dose, mandated brain scan studies
• Real world experience of EGFRm patient journey to inform TKI treatment strategy

Use of Diagnostics

• Evaluating other prognostic biomarkers of osimertinib response and/or outcome with TAGRISSO
• Improving efficiency, implementation, and interpretation of testing workflows and pathways in the context of disease management for lung cancer patients, including (but not limited to) EGFR mutation testing
• Better understand the tumor biology and heterogeneity of T790M and EGFRm disease, especially at resistance

Treatment of CNS Disease: Brain Metastasis and Leptomeningeal Disease

• Treatment of  T790M+ and T790M- patients Brain Metastasis and/or Leptomeningeal Disease (asymptomatic and symptomatic)
• 1^st line Treatment of CNS Disease including dose escalation strategies to treat refractory pre-existing lesions or on CNS progression
• Use of Osimertinib in combination with Radiation Therapy (SRS and WBRT), Including: Time to cranial Radiation therapy endpoints and sequencing of local cranial RT (SRS or WBRT) and systemic osimertinib treatment (including combinations)
• 3^rd Line CNS disease e.g. Treatment Beyond Progression, refractory CNS disease
• Mechanisms of CNS resistant disease (across lines of treatment)
• Other CNS tumors (e.g. GBM)

Immunotherapy areas of focus

• Building translational biological understanding across disease segments
• Exclude any IO treatment approaches

Pre-clinical activities

• Use of pre-clinical derived mechanisms of resistance to inform clinical hypotheses and translational strategies, in particular non-genomic mechanisms.
• Use of patient derived xenograft models representing key areas of interest across EGFRm disease
• Studies to build evidence generation to support clinical opportunities in tumour-targeted or immune-therapy treatment areas

Special populations of interest

• Tx of patients with rare mutations (excluding Exon20Ins) and early stages of disease e.g. pre-surgical window studies, neoadjuvant studies, un-resectable stage 3
• Retrospective Real World Treatment data sets

MEDI9197

Make a submission

TLR 7agonist

Accepting limited number of Externally Sponsored Clinical Research Proposals

MEDI0457

Make a submission

HPV vaccine

Accepting limited Externally Sponsored Clinical Research Proposals in combination with durvalumab in H&N”. 

MEDI0562

Make a submission

Humanized immunoglobulin G1 kappa (IgG1κ) monoclonal antibody (mAb) that specifically binds to and triggers signaling of human OX40

Accepting limited Externally Sponsored Clinical Research Proposals

Monalizumab

Make a submission

NKG2A

Accepting limited Externally Sponsored Clinical Research Proposals

Savolitinib

Make a submission

c-Met receptor tyrosine kinase inhibitor (TKI)

Savolitinib monotherapy proposals in MET-driven solid tumours (ie tumours with MET gene amplification, activating MET mutations, MET fusions or HGF amplifications) will be considered in tumour types other than papillary renal cell carcinoma (pRCC), gastric cancer, castration resistant prostate cancer (CRPC) and paediatric brain tumours. Only proposals requesting study drug alone can be considered at this juncture.

Selumetinib /
AZD6244

Make a submission

MEK 1/2 Inhibitor

Not accepting Externally Sponsored Clinical Research Proposals at this time. Externally Sponsored ‘Non-Clinical’ Research proposals are still being considered but only where sponsors require supply of drug and not funding support.

Tremelimumab

Make a submission

Anti-CTLA4 Mab

Proposals for Oncology indications using tremelimumab alone or in combination with other products (with the exception of durvalumab-based combinations - see the durvalumab areas of interest for further information), are not sought at this time. Proposals for non-oncological indications may be of interest.

Zibotentan /
ZD4054

Make a submission

Endothelin receptor A (ETA) antagonist

Proposals for Oncology indications are not sought at this time. Proposals for non-oncological indications may be of interest

Zoladex (goserelin)

Make a submission

LHRH agonist

Not accepting non-clinical Externally Sponsored Research Proposals at this time

Accepting the following clinical Externally Sponsored Research Proposals:

• No new proposals are being considered for the US and Japan
• Prostate Cancer early or locally advanced disease: combination with novel targeted agents
• Prostate Cancer Metastatic disease: in combination with chemotherapy, other therapies or novel targeted agents. Sequencing strategies and response after progression on anti-androgens
• Benign Gynaecology
• Breast cancer: comparison of Zoladex + Tamoxifen with modern chemo regimens in HR+ pre-menopausal patients in early BC

Brand/Substance

Mechanism of action

ESR - Areas of interest

AZD1236

Make a submission

Matrix metalloproteinase 9 & 12 (MMP9,12) inhibitor

• The reproductive toxicology package indicates a risk of fetal toxicity. The inclusion of women of child-bearing potential would need to be assessed for any proposal based on the risk-benefit and the use of appropriate highly effective contraception
• The risk of muscular skeletal syndrome (MSS; joint fibrodysplasia), while reversible, has been seen after chronic administration with other MPP inhibitors in humans and fibrodyplasia in the subcutis has been seen at high doses in the 12 month preclinical safety study with AZD1236. This risk must be considered when proposing a new indication and associated treatment regimen

AZD1981

Make a submission

CRTh2 Inhibitor

• Preclinical reprotoxicology data is available and has not identified any specific risks. Women of child-bearing potential using highly effective contraception can be included
• Given the potential for DDI and LFT effects, dosing regimen (level and duration) as well as inclusion/exclusion criteria should be selected carefully to support a favourable risk-benefit
• There is currently no clinical data to support use in pediatric populations below 12 years of age, although existing preclinical data would support clinical studies in a pediatric population of > 5 years

AZD5904

Make a submission

Myeloperoxidase (MPO) inhibitor

• The reproductive toxicology package indicates a risk of fetal toxicity. The inclusion of women of child-bearing potential would need to be assessed for any proposal based on the risk-benefit and the use of appropriate highly effective contraception
• AZD5904 is renally cleared, thus, requiring caution and PK monitoring if dosed to subjects with impaired renal function

AZD9668

Make a submission

Neutrophil elastase (NE) inhibitor

• Preclinical reprotoxicology data is available and has not identified any specific risks. Women of child-bearing potential using highly effective contraception can be included
• Due to elevations in liver enzymes noted in Ph2 studies, LFTs should be monitored and a careful benefit/risk assessment as well as exclusion criteria considered for any future clinical study

Benralizumab

Make a submission

Anti-IL-5Rα monoclonal antibody

Studies in Asthma and COPD which address the following:

• Role of eosinophils and other biomarkers in the lung and in systemic inflammation in COPD
• Role of eosinophils in different triggers of asthma  and COPD exacerbations (e.g. infectious, allergic)
• Characterization and burden of eosinophilic COPD
• Understanding the effect of benralizumab on airway remodeling in asthma and COPD, and disease progression in COPD
• Mechanistic study of EOS or BASO tissue depletion by benralizumab in relevant human setting/model in asthma and COPD

Budesonide / Glycopyrronium / Formoterol (PT010)

Make a submission

ICS, LAMA, LABA

1.     COPD: Understand the treatment journey of exacerbating patients in need of step-up

• Explore the extent of underdiagnosis of COPD and under-/un-reporting of AECOPD by patients.
• Explore novel biomarkers / treatable traits and pheno- and endotypes associated with differential outcomes in COPD.

2.     Asthma: Establish the benefits of LAMAs beyond bronchodilation in asthma

• Explore the role Acetylcholine (Ach) plays in a) bronchial reactivity and remodelling; b) inflammatory cell chemotaxis and activation and c) rhinovirus (RV) infections.

3.     Device: Importance of pMDI device

• Establish the benefits of using a single device platform (pMDI a.n. + maintenance) in more severe patients.

Duaklir (aclidinum/formoterol)

Make a submission

Long Acting Muscarinic Antagonist (LAMA)/Long Acting Beta Agonist (LABA)

• Studies assessing the impact of sleep, nocturnal symptoms, early morning symptoms, day-time symptoms, breathlessness and cough in COPD patients
• Studies investigating the combination of aclidinum and formoterol with ICS (e.g. Pulmicort)
• Studies assessing Patient Reported Outcome (PROs)
• Studies assessing physical activity and symptoms in COPD patients
• Studies assessing Quality of Life (QoL)
• Studies investigating muscle endurance
• Studies investigating Duaklir’s impact on the sexual life in COPD patients

Eklira (aclidinum)

Make a submission

Long Acting Muscarinic Antagonist (LAMA)

• Studies assessing the impact of sleep, nocturnal symptoms, early morning symptoms, day-time symptoms, breathlessness and cough in COPD patients
• Studies investigating Asthma COPD Overlap Syndrome
• Studies investigating the combination of aclidinum with a fixed dose LABA/ICS (e.g. Symbicort)
• Studies assessing Patient Reported Outcome (PROs)
• Studies assessing physical activity and symptoms in COPD patients
• Studies assessing Quality of Life (QoL)
• Studies investigating muscle endurance

Glycopyrronium / Formoterol (PT003 (Bevespi))

Make a submission

LAMA, LABA

Studies that increase the knowledge about:

• Symptom control Impact in patients’ activities of daily living and quality of life
• Early morning symptoms, including
• impact on QoL, disease progression and cost of care
• prevalence in general COPD population
• subsets of patients that most experience these symptoms
• tool and mechanisms of detection/evaluation
• Treatment pathways according to disease progression
• Current drivers of choice for COPD treatment (device and drug)
• ACOS identification and treatment pathways
• Optimization of device choice and training
• Impact of 24 hour symptoms (DT, NT/EM) and sleep quality post dual bronchodilators/PT003 (Bevespi)
• Beneficial treatment effects of dual bronchodilation/PT003 (Bevespi), on physiological, neuropsychiatric, or patient reported outcomes (including common COPD comorbid conditions such as: cardiac disease, depression & sleep disorders)

MEDI551

Make a submission

MAb

Anti-CD19 B cell depleting agent

• Autoimmune diseases that have B cell etiology. Of particular interest are autoimmune disease in the areas of neuro-inflammatory, rheumatoid and dermatology
• The Company will supply drug only (no funding is available at this time)

None

N/A

• Biomarkers of response to inhaled corticosteroid-containing therapies in COPD
• Biomarkers to characterize COPD pheno and/or endotypes that benefit from non-ICS-containing therapies
• Understand inflammation in COPD vs. non-inflammatory features of the disease (e.g. structural changes)
• Differentiation of COPD exacerbation types (e.g. infectious vs. non-infectious)
• ICS-containing therapy in early (vs. mild or severe) COPD, in order to prevent disease progression
• Role of PDE4 inhibition in COPD-related inflammation

Pulmicort
(budesonide)

Make a submission

Anti-inflammatory corticosteroid

• Budesonide’s contribution in preventing COPD exacerbations
• Device – adherence, consequences of switching device
• Budesonide differentiation vs. other ICS
• Biomarkers or other novel intermediate endpoints both asthma and COPD
• Niche patient populations; exploratory studies
• Asia – treatment patterns
• Early intervention in very young asthma patients as disease modification factor

Symbicort
(budesonide /
formoterol)

Make a submission

Inhaled steroid/long acting Beta2 agonist

• Symbicort preventing COPD Exacerbations
• Symbicort SMART in Asthma
• Adolescents – behavior and treatment adherence
• Device – adherence, consequences of switching device
• Budesonide differentiation vs. other ICS
• Biomarkers or other novel intermediate endpoints
• Niche patient populations; exploratory studies
• Asia – treatment patterns
• COPD/Asthma overlap diagnostic markers
• COPD/Asthma overlap markers for ICS benefit
• Early intervention in young asthma patients as disease modification factor

Tralokinumab

Make a submission

Anti-IL-13 monoclonal antibody

Accepting the following clinical Externally Sponsored Research Proposals:

• Studies relating to understanding of IL-13 attenuation in response to pathogen challenge
• Longitudinal studies relating to increasing understanding of biomarker modulation in patients with uncontrolled asthma
• Studies that contribute to the understanding of the pathophysiology and impact of uncontrolled asthma on individuals or healthcare systems
• Studies exploring the potential for patient benefit in other indications including but not limited to  chronic rhinosinusitis with nasal polyposis and eosinophilic esophagitis

Accepting the following non-clinical Externally Sponsored Research Proposals:

• Any aspect of interleukin-13 (IL-13) or T helper 2 (Th2) driven (i.e. IL-4) biology that pertains to cellular responses in isolated cell or co-culture systems relevant to human asthma or any human disease for which IL-13 may play a role
• Of specific interest are studies that may relate to epithelial and or smooth muscle function, repair and remodeling, attenuation of the IL-13 signaling pathway in response to standard of care treatment in patients with uncontrolled asthma and co-administration studies with standard of care treatment
• Translational studies relating to the identification of novel biomarkers relevant to patients with uncontrolled asthma or other allergic disease such as atopic dermatitis
• Translational studies relating to attenuation of biomarkers relevant to the type 2 cytokine axis by standard of care treatment and/or novel drugs in clinical development, understanding of biomarkers relevant to the type 2 axis throughout childhood and adolescence