BLU stock exploded more than 63% in morning trade on December 13, 2021, after the company released clinical trial data that met primary endpoints.
BELLUS Health Announces Positive Topline Results from its Phase 2b SOOTHE Trial of BLU-5937 for the Treatment of Refractory Chronic Cough
Primary efficacy endpoint statistically significant with 34% placebo-adjusted reduction in 24-hour cough frequency observed at 50 mg and 200 mg BID doses (p ≤ 0.005)
BLU-5937 was well-tolerated with a low rate of taste-related adverse events (≤6.5%); treatment emergent adverse event profile comparable to placebo
Company also provides an update on its P2X3 pipeline and BLU-5937 Phase 2a trial for the treatment of chronic pruritus
LAVAL, Quebec–(BUSINESS WIRE)– BELLUS Health Inc. (Nasdaq:BLU; TSX:BLU) (“BELLUS Health” or the “Company”), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of refractory chronic cough (“RCC”) and other hypersensitization-related disorders, today announced that the 50 mg and 200 mg BID doses of BLU-5937 in its Phase 2b SOOTHE trial for the treatment of RCC achieved statistical significance on the primary endpoint with 34% placebo-adjusted reduction in 24-hour cough frequency observed (p ≤ 0.005) at day 28. BLU-5937 was generally well-tolerated, with low rates of taste-related adverse events reported (≤6.5%) at all doses.
Mr. Roberto Bellini, Chief Executive Officer of BELLUS Health commented, “We are extremely pleased with the compelling topline results from the Phase 2b SOOTHE trial which highlight BLU-5937’s best-in-class potential for the treatment of refractory chronic cough. RCC is a prevalent and growing condition that significantly impacts the quality of life of an estimated 9 million patients in the United States and 9 million patients in Europe.”
Summary of Topline Results: Phase 2b SOOTHE Trial in Refractory Chronic Cough
The SOOTHE trial, which enrolled 249 participants with a baseline awake cough frequency of ≥ 25 per hour, demonstrated a clinically meaningful and statistically significant placebo-adjusted reduction in 24-hour cough frequency of 34% at the 50 mg and 200 mg BID dose levels of BLU-5937 (p ≤ 0.005) at day 28. The 12.5 mg BID dose demonstrated a statistical trend with 21% reduction in placebo-adjusted 24-hour cough frequency (p=0.098) with a dose response observed between the 12.5 mg and 50 mg BID doses.
BLU-5937’s safety and tolerability data were consistent with previous trials, including the Phase 2a RELIEF trial. BLU-5937 was well-tolerated with low impact on taste perception. Taste-related side effects were infrequent at all dose levels with taste alteration 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 participant reported complete or partial taste loss and there were no discontinuations due to taste-related adverse events.
The treatment emergent adverse event profile was comparable to placebo. There were no treatment emergent serious adverse events reported in the trial.
The Company intends to request an End of Phase 2 meeting with the FDA that is expected to take place in 2Q 2022 to discuss the Phase 3 program which is expected to start in 2H 2022.
“With no specific treatments approved for refractory chronic cough, patients and physicians struggle to manage this condition that significantly impacts the quality of life of those afflicted. The SOOTHE trial topline results generated from this large, multicenter, controlled trial are truly exciting because the impressive efficacy and tolerability profile observed for BLU-5937 could significantly benefit refractory chronic cough patients,” said Dr. Jaclyn Smith, Professor of Respiratory Medicine at the University of Manchester in the United Kingdom and an Honorary Consultant at the University Hospital of South Manchester NHS Foundation Trust, and Principal Investigator of the Phase 2b SOOTHE trial.
Dr. Catherine Bonuccelli, Chief Medical Officer of BELLUS Health added, “The Phase 2b SOOTHE topline results demonstrated an important treatment benefit of BLU-5937 and its potentially best-in-class tolerability profile, with low taste-related side effects observed. We look forward to incorporating the SOOTHE results into our accelerated planning for Phase 3 with the objective of bringing this treatment option to patients with refractory chronic cough as efficiently as possible.”
Bellus Health price target raised to $20 from $12 at Evercore ISI
Evercore ISI analyst Josh Schimmer raised the firm’s price target on Bellus Health to $20 from $12 and keeps an Outperform rating on the shares, stating that the Phase 2b SOOTHE trial of BLU-5937 for high cough frequency “did not disappoint.” He thinks the stock should be trading at “well over” $10 per share today, but also says its hard to predict where shares will settle given “a choppy biotech tape and financing overhang.” The 34% pbo-adjusted reduction in cough frequency reported beat expectations of 20-25%, Schimmer said.
VIDEO STEVE COHEN BOUGHT THIS $3 PENNY STOCK – 6.2 Million Shares
Back on January 30, 2021, Market Gains talked about how Steve Cohen bought millions of dollars worth of BLU stock.
BLU Stock Technical Analysis
BLU is one of the better-performing stocks in the Biotechnology industry, it outperforms 97% of 624 stocks in the same industry. When comparing the yearly performance of all stocks, we notice that BLU is one of the better-performing stocks in the market, outperforming 95% of all stocks. The large players volume has exploded higher which is bullish. We also observe that the gains produced by BLU over the past year are nicely spread over this period. BLU is currently making a new 52 week high. This is a strong signal. The S&P500 Index however is also trading near new highs, which makes the performance in line with the market. There is a support zone ranging from 5.25 to 5.25. This zone is formed by a combination of multiple trend lines in multiple time frames. There is also a support at 7.01 from a trend line in the weekly time frame. BLU has an average technical rating and it also does not offer a high-quality setup at the moment. Prices have been extended to the upside lately. For a nice entry it is better to wait for a consolidation. Click here to sign up for email alerts on when BLU stock technicals change.