GSK new drug: camlipixant
R&D code: BLU5937
CAS: 1621164-74-6
Indication: Refractory chronic cough
Company: GSK
Development Phase: Phase 3
On December 13, 2021, BELLUS Health announced positive top-line results from the Phase 2b SOOTHE clinical trial of camlipixant for the treatment of refractory chronic cough.
The SOOTHE trial, which enrolled 249 participants with a baseline waking cough frequency of ≥25 /hour, showed a clinically meaningful and statistically significant 34% reduction in 24-hour cough frequency at the 50 mg and 200 mg BID dose levels of BLU-5937 (p ≤ 0.005) administered over 28 days. the 12.5 mg BID dose showed a statistically significant trend of placebo-adjusted 24-hour cough frequency was reduced by 21% (p=0.098), and a dose response was observed between the 12.5 mg and 50 mg BID doses.
Safety and tolerability data for BLU-5937 were consistent with previous trials, including the Phase 2a RELIEF trial.BLU-5937 was well tolerated and had a minor effect on taste. Taste-related side effects were uncommon at all dose levels, with taste alterations observed in 4.8%, 6.5%, and 4.8% of participants at 12.5 mg BID, 50 mg BID, and 200 mg BID, respectively. No participants reported complete or partial loss of taste, and there were no treatment interruptions due to taste-related adverse events.
On April 18, 2023, GSK announced the acquisition of BELLUS Health for $2 billion in cash.
Compound Patents
WO2014117274, applicant NEOMED Research Institute, filing date January 31, 2014.In February 2017, Bellus Health received an exclusive worldwide license from the NEOMED Research Institute for the development of the BLU-5937 intellectual property.In March 2020, the Company received a license for the BLU-5937 intellectual property from adMare BioInnovations (previously as NEOMED Institute) acquired the BLU-5937 IP and R&D assets.
