Before the market open on July 6th Bellus Health (NASDAQ:BLU) announced disappointing topline results from its Phase 2 RELIEF trail involving BLU-5937 as a treatment for refractory chronic cough. Investors aggressively sold out of the company’s stock in reaction to the news. The stock had dropped nearly 70% in midday trading.
BLU-5937 did not meet the study’s primary endpoint of a placebo-adjusted reduction in awake cough frequency. The safety profile of the treatment was favorable with patients experiencing little impact on taste perception.
Bellus is a Canadian biotechnology company that develops therapeutics for the treatment of chronic cough, chronic pruritis, and other hypersensitization-related disorders.
All dose levels fail to achieve statistical significance
Biopharmaceutical drug trials often see mixed results in the form of higher dosage levels having better results than lower dose levels. This was not the case in the Phase 2 trial of BLU-5937, however, as all tested doses fell short of the primary endpoint.
Four dose levels were tested in the study which enrolled 62 patients with refractory chronic cough. The lowest dose level of 25mg administered twice-daily achieved a statistically insignificant cough frequency reduction of 11%. The highest dose level of 200mg had a 17% cough frequency reduction, however this result was also statistically insignificant.
Patients participated in the trial from 16 locations across the U.S. and the United Kingdom. Several patients dropped out of the trial due to difficulties in conducting follow-up appointments amid the COVID-19 pandemic.
The company did, however, note that highly statistically significant results were achieved in a sub-group of high cough count patients. The sub-group was defined as those patients that were above the baseline median average of 32.4 coughs per hour. This patient cohort experienced a cough frequency reduction of as much as 32% with the 200mg dosage.
President and CEO Roberto Bellini stated, “While we had hoped to see more response in the lower cough patients, BLU-5937 and other P2X3 antagonists may have the most benefit in patients with a greater disease burden.”
Since BLU-5937 was shown to have a greater impact on higher cough count patients, company management noted that it plans to move forward with an adaptive Phase 2b trail as part of a patient enrichment strategy. It anticipates that this trail will begin in the fourth quarter of this year.
There have yet to be any treatments approved for refractory chronic cough, which affects millions of people around the world. Approximately 26 million U.S. adults suffer from some form of chronic cough, about 3 million of which have refractory chronic cough lasting over one year.
Despite the poor overall results, Bellus Health’s analysis of higher cough count patients is a source of optimism. But because BLU-5937 is the company’s lone product candidate it may have a long road back in investors’ eyes. Bellus Health is scheduled to report second quarter results on August 13th.