BLU-5937 remains in development and has not been approved for commercialization. The clinical safety and effectiveness of BLU-5937 have not yet been fully established. The development of this product, and an investment in BELLUS Health common shares, involved a significant amount of risks. We invite you to review our Annual Information Form to learn more about these risks factors. A summary of these can also be reviewed here.
Pipeline
BLU-5937
BLU-5937
BLU-5937
BLU-5937 is a potent P2X3 receptor antagonist with high selectivity for P2X3 (>1500 fold) over P2X2/3. In healthy volunteers, BLU-5937 showed good drug and pharmacokinetic characteristics.1
Bellus Health is currently developing BLU-5937 for the treatment of refractory chronic cough, a condition with a high unmet medical need and a significant market opportunity.
| Program | Development | Status | Indication/ProjectInd/Proj | PreclinicalPre | Phase 1Ph1 | Phase 2Ph2 | Phase 3Ph3 | Worldwide RightsRights | Next Anticipated MilestoneNext |
|---|---|---|---|---|---|---|
BLU-5937 | ||||||
BLU-5937 | ||||||
| Refractory Chronic Cough (BID Formulation) |
Refractory Chronic Cough (BID Formulation)
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2H 2024: CALM-1 Topline Results |
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| Refractory Chronic Cough (QD Formulation) |
Refractory Chronic Cough (QD Formulation)
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1H 2023: Phase 1 Study Completion |
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References
1. Garceau et al. Am. J. Resp Crit Care Med. 2019 199 A7395 P556.
Refractory Chronic Cough
Chronic cough is a cough lasting longer than eight weeks and may affect up to 10% of the global population.1 When the cause of chronic cough cannot be identified or the cough persists despite treatment of all identified associated causes, the condition is referred to as refractory chronic cough. Refractory chronic cough can cause significant physical, psychological, and social burdens.2 There is no therapy approved to date for refractory chronic cough.
Next Steps
In December 2021, BELLUS announced positive topline results from the Phase 2b SOOTHE trial, highlighting BLU-5937’s best-in-class potential for the treatment of refractory chronic cough. In the fourth quarter of 2022, we initiated the CALM Phase 3 clinical program. The CALM program consists of two pivotal trials, CALM-1 and CALM-2, with the primary endpoint of 24H cough frequency measured at 12- and 24-weeks, respectively. Topline results from CALM-1 are expected in the second half of 2024, with topline results from CALM-2 expected in 2025.
References
1. Song et al. Eur Respir J. 2015 45(5):1479-81 2. Morice et al. 2014 Eur Resp J 44(5) 1132-48