Expert Interview
Discussing Bellus BLU-5937 against Merck's gefapixant in Chronic cough, following recent Phase 2b results and FDA meeting
Ticker(s): BLU, MRKInstitution: Medical College of Georgia
- Clinical professor of pediatrics at Medical College of Georgia in Augusta, Georgia, executive medical director of the American College of Allergy, Asthma and Immunology.
- Author of 2022 ATS presentation, "Safety and Efficacy of BLU-5937 in the Treatment of Refractory Chronic Cough from the Phase 2b Soothe Trial"
- Published more than 180 scientific peer-reviewed articles and presented at more than 500 meetings and seminars throughout the world on on such topics as allergic rhinitis, asthma, socioeconomic issues for allergists in the new millennium and issues in compliance and adherence.
Please describe your clinical practice. How many patients with Chronic cough do you see on a yearly basis? What is the standard of care (Antihistamines / corticosteroids/ decongestants)? What works best in your patients and why?
Added By: catalin_adminCan you please tell us about the details and mechanism of action for BLU-5937 as a P2X3 receptor antagonist with high selectivity for P2X3 (>1500 fold) over P2X2/3?
Added By: catalin_adminBased on the FDA's feedback, the CALM Phase 3 program is composed of two pivotal trials, similar to Merk’s. Placebo-controlled, parallel-arm trials randomized 1:1:1 with expected treatment arms of 25 mg BID, 50 mg BID and placebo. The primary endpoint of 24H cough frequency will be measured at 12-weeks for CALM-1 and 24-weeks for CALM-2. Can you please discuss this?
Could you please give us your opinion on Bellus’ SOOTHE Phase 2b trial results, where:
- Improvements in 24H cough frequency over placebo were observed after 28 days at the 50 and 200 mg BID doses (-34.4 %, p=0.003 and -34.2%, p=0.005, respectively).
- Similar improvements were observed after 15 days of treatment: -32.4, p= 0.004 and -34.3% p=0.002, for the 50 and 200 mg BID doses, respectively. The 12.5 mg BID dose demonstrated a statistical trend (p=0.098), with 21.1% placebo-adjusted reduction at Day 28.
- Change from baseline in cough frequency in participants treated with placebo was -28.0% at Day 28. Overall, participants reported a similar incidence of treatment emergent adverse events (TEAEs) for BLU-5937 and placebo. No serious TEAEs were reported. Dysgeusia was reported by participants at an incidence of 4.8%, 6.5%, 4.8% and 0% for the 12.5 mg, 50 mg and 200 mg BID and placebo groups, respectively. No complete or partial taste loss was reported.
- After 28 days of treatment, 51.7%, 60.6%, 61.5% and 35.7% experienced at least 30% improvement in 24H cough frequency for the 12.5, 50 and 200 mg BID doses and placebo, respectively.
- Furthermore, 34.5%, 44.3%, 48,1% and 14.3% of participants experienced at least 50% improvement and 19.0%, 24.6%, 19.2%, and 7.1% experienced at least 70% improvement in 24H cough frequency at the 12.5, 50 and 200 mg BID doses and placebo, respectively.
Added By: catalin_admin
Where would you put the chance for Merk to perform a secondary Phase 3 study and have extended timelines? Would BLU-5937 have a more favorable pathway in that eventuality?
How likely would you be to prescribe BLU-5937 for chronic cough patients, if approved in the future?
Added By: catalin_adminAre You Interested In These Questions?
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