Yahoo Finance Bristol Myers (BMY) Reports Pulmonary Fibrosis Study Results
Bristol Myers Squibb BMY announced encouraging results from a mid-stage study evaluating pipeline candidate BMS-986278 in patients with idiopathic pulmonary fibrosis.
The candidate is a potential first-in-class, oral, small-molecule lysophosphatidic acid receptor 1 (LPA1) antagonist currently being evaluated as a novel antifibrotic treatment for patients with idiopathic pulmonary fibrosis and progressive pulmonary fibrosis.
Patients were randomized (1:1:1) to placebo, 30 mg or 60 mg of BMS-986278 twice daily for 26 weeks in this phase II study. Two-thirds of patients were on background antifibrotic therapy during the trial. Patients who met prespecified blood pressure reduction criteria were to receive a dose reduction of 10 mg of BMS-986278 or a matching placebo twice daily.
The results showed that twice-daily administration of 60 mg of BMS-986278 over 26 weeks reduced the rate of decline in percent predicted forced vital capacity (ppFVC) by 62% compared to the placebo and a 54% reduction versus placebo in the treatment policy analysis. The primary endpoint was rate of change in ppFVC from baseline to week 26.
The company also used a prespecified Bayesian analysis to evaluate the probability of a positive treatment difference for BMS-986278 compared to placebo. This analysis showed a greater than 95% probability that 60 mg of BMS-986278 was superior compared to placebo in reducing the rate of decline in ppFVC over 26 weeks in both the while-on-treatment and treatment policy estimands (similar to an Intention-to-Treat [ITT] analysis).
However, the 30 mg dose was not effective versus placebo.
The candidate was well tolerated in both treatment arms, with rates of adverse events, including gastrointestinal side effects and treatment discontinuation comparable to placebo.
The data demonstrates the potential of BMS-986278 in pulmonary fibrosis and support progression into phase III.
The company’s shares have lost 8.1% in the year so far compared with the industry's decline of 6.5%.
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The successful development of new drugs will enable Bristol Myers to diversify its product base and offset the slowdown in top-line growth as one of its prime drugs, Revlimid, is facing generic competition.
The company’s psoriasis drug Sotyktu (deucravacitinib) recently got approved by the European Commission (EC). Sotyktu is a first-in-class, selective tyrosine kinase 2 (TYK2) inhibitor for treating adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy, representing a new way of treating this chronic immune-mediated disease. It is already approved in the United States.
Bristol Myers beat first-quarter 2023 earnings estimates but missed on sales, which declined year over year due to continued generic competition for Revlimid. Generic competition for Eliquis is another headwind.
Bristol Myers currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the overall healthcare sector are Novo Nordisk NVO and Ligand Therapeutics LGND, both sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 30 days, estimates for Novo Nordisk’s 2023 earnings per share have risen from $4.84 to $5.07. Estimates for 2024 have increased by 34 cents to $5.91.
Ligand’s earnings per share estimates for 2023 increased to $4.79 from $4.15 in the past 60 days. Estimates for 2024 have increased by 30 cents to $4.58.
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