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)

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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

Roxadustat

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Oral, hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI)

Real World Evidence: local data generation to describe anaemia and its management, CKD.
 

Active drug trials with Roxadustat: will only be considered after Roxadustat is authorised in the country of the applicant. Areas of interest will be:

• Outcomes: effect on CKD progression, ESA hyporesponsiveness, hospitalisations, and CV risk
• Special populations: inflammation, elderly, peritoneal dialysis, incident dialysis
• Patient reported outcomes: including QoL, and nutrition
• Economic value: Resource utilization, HR QoL, adherence and persistence
• Iron metabolism: Iron utilisation, Hemoglobin variability, Hepcidin levels
• Treatment patterns: evaluation of monitoring, treatment protocols, dosing regimens

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
• Given the potential effects on liver enzymes, dosing regimen (level and duration) as well as inclusion/exclusion criteria should be selected carefully to support a favourable risk-benefit.

Nexium (esomeprazole)

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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

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

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

AZD4635

Oral inhibitor of adenosine 2a receptor (A2aR)

• Proposals should be supported by a strong scientific rationale, preclinical data package and specific hypotheses to address
• Proposals will be prioritized accordingly based on scientific merit and fit with the core development program
• Areas of interest include exploration of monotherapy or combination treatment in indications where there is strong scientific or translational rationale to target the adenosine pathway

Acalabrutinib

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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.

AZD5069

Make a submission

Chemokine (C-X-C motif) receptor 2 (CXCR2) antagonist

• Preclinical reprotoxicology data are available and have not identified any specific risks. Women of child-bearing potential using highly effective contraception can be included.
• Indications and dosing regimen should consider the potential for and optimization of efficacy compared to the mechanism-based effects on circulating neutrophil counts.
• Only proposals in the following therapeutic area will be considered: oncology, respiratory, cardiovascular, renal or metabolic disease; all other disease indications are out-of-scope.

AZD5153

Make a submission

BRD4/BET bromodomain inhibitor

• Monotherapy in MYC or BRD4-amplified tumor types
• Combinations studies with chemotherapy or other novel agents in solid or hematologic indications
• Proposals will be prioritised accordingly based on scientific merit and fit with the core development programme
• Proposals should be supported by a strong scientific rationale and preclinical data package, or proposals to generate such data

Capivasertib / 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

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

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

EGFRm NSCLC

Resistance/What next?

• Rapid identification of 1L resistance mechanisms using tissue, to accelerate new combination options
• Benefit/risk of treatment beyond progression
• Understand biomarkers of poor initial response to 1L TAGRISSO
• Extend survival benefit using TAGRISSO in combination with  targeted and non-targeted approach’s
• Establish evidence to support appropriate position of IO agents in EGFRm patients (advanced and early disease)

Real World Evidence

• Generate RWE data on 1L TAGRISSO including patient preference 
•  Develop insights into the 1L treatment journey to reinforce the benefits of starting with the best EGFR TKI first
• Assess the risk of CNS disease progression with 1^st and 2^nd generation TKIs, including in Leptomeningeal patients
• Develop treatment insights into the early disease setting, including EGFR prevalence through early screening

CNS

• Build prospective evidence for CNS risk reduction
• Build efficacy in leptomeningeal metastases, and symptomatic CNS patients using the 80mg dose
• Use of TAGRISSO in combination with Stereotactic radiotherapy, and in combinations with other systemic agents

Early Disease

• Translational assessment of tumour micro-environment post-surgery in the neoadjuvant setting
• Address optimal treatment strategy for downstaging tumors (e.g. unresectable to resectable)
• Optimize treatment in unresectable patients (e.g. in non-CRT eligible EGFRm patients)
• Explore ctDNA and other biomarkers to help guide treatment decisions in the early disease setting (E.g. optimal duration of therapy)

EGFR Testing

• Optimization of 1L testing to improve turnaround times
• Identify new testing approaches to improve the quality and speed of treatment decisions in metastatic and early disease
• Understand the prevalence and impact of other biomarkers e.g. uncommon, PD-L1, emerging IO related biomarkers, and impact on outcomes

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

Saracatinib / AZD0530

Make a submission

• The reproductive toxicology package indicates a risk of foetal 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.
• AZD0530 is a moderately potent CYP3A4 inhibitor; concomitant administration of medicines that are metabolised by this route should be avoided.
• We are not currently seeking proposals in oncology indications

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

Benralizumab

Make a submission

Anti-IL-5Rα monoclonal antibody

• Studies in patients with eosinophilic asthma to:
  • Investigate and identify predictors of enhanced response to benralizumab
  • Understand the overlap between different T2 biomarkers and the effects of benralizumab
  • Investigate early onset of patient-centric and clinical benefits of benralizumab
• Mechanistic studies in relevant disease-state models to:
  • Study the effect of eosinophil depletion by benralizumab on airway structure/function and cellular/molecular pathology
  • Characterise the role and effect of benralizumab on other IL-5R expressing cells beyond eosinophils

• Benralizumab lifecycle management:
  • Real world studies in eosinophil-driven diseases other than asthma that provide information about patient characteristics and disease burden
  • Mechanistic or clinical studies in eosinophil-driven diseases other than asthma that are not addressed by currently sponsored development programmes

budesonide / glycopyrronium / formoterol FDC in COPD

Make a submission

ICS, LAMA, LABA

• Studies related to exacerbations and/or suitable patient populations
  • Impact of first and subsequent exacerbations
  • Clinical and economic impact of non-severe exacerbations
  • Identification of patients that are at risk of exacerbation
  • Evidence supporting the role of triple therapy in symptom improvement
  • Identification of patients  likely to respond to ICS
• Studies related to the clinical/economic benefit of ICS as part of triple therapy
  • Budesonide compared with other ICS
  • Relationship between safety/tolerability and patient benefit of FDC triple therapy
  • Clinical/Economic impact of ICS use as an early treatment for COPD
• The role of Device/Technology
  • The benefit of pMDI device in patients with COPD
  • Novel technologies to measure clinical response, including imaging and mechanistic studies
  • Evidence informing the value proposition of connected device technology

budesonide /
formoterol

Make a submission

Inhaled steroid/long acting Beta2 agonist

• Studies to investigate:
  • Correlations between SABA use, ICS use and patterns of asthma exacerbations
  • Mechanisms linking the variability of inflammation, symptoms and exacerbations
  • Long-term health consequences of intermittent OCS bursts
  • Real-world clinical and economical benefits of budesonide/ formoterol as a reliever across all asthma severities.
  • How timing of the dose affects outcomes
  • Exercise-induced bronchoconstriction
  • Discharge protocols and readmission rates for Emergency Departments
  • Interventions to overcome reliance on SABA monotherapy during rescue situations
  • Other respiratory diseases where inflammatory ‘flare ups’ are treated with OCS

Tezepelumab

Make a submission

Anti-TSLP monoclonal antibody

• Tezepelumab in severe asthma
  Studies to:
  • Increase present understanding of TSLP-driven inflammation beyond eosinophilic/T2 asthma
  • Understand the role of TSLP in modulating epithelial health
  • Investigate the potential role of TSLP in different asthma endotypes and phenotypes i.e. eosinophils, IgE, FeNO etc.
  • Investigate the role of TSLP in different types of respiratory exacerbations (e.g. triggers)
  • Investigate mechanism of action of tezepelumab in asthma and effects on airway/structure function and cellular/molecular pathology

None

Make a submission

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

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

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)