Bristol Myers Squibb is sharing its phase 2 results at the European Respiratory Society 2023 international congress this week. Angling for the first-in-class title, BMS’ investigational LPA1 antagonist BMS-986278 triumphed in a phase 2 study in patients with progressive pulmonary fibrosis (PPF). At 26 weeks, two daily 60-mg doses of BMS' candidate reduced the rate of decline in percent predicted forced vital capacity (ppFVC)—a key measure of lung function in patients with PPF—by 69% versus placebo. BMS is sharing the results at the European Respiratory Society 2023 international congress this week.
Notably, 38% of patients in the study received a background antifibrotic therapy like Roche’s pirfenidone, also known as Esbriet, or Boehringer’s nintedanib, which goes by the commercial moniker Ofev. BMS-986278’s success on top of existing pulmonary fibrosis treatments suggests the drug could have potential as an add-on to established therapies. In BMS’ phase 2 study, parallel cohorts of IPF and PPF patients received 30 mg or 60 mg of the company’s LPA1 prospect twice daily over 26 weeks. Things didn’t go as smoothly for the lower dose of the drug, which only charted a 42% relative reduction in forced vital capacity versus placebo.
However, BMS noted that across doses, treatment was consistent with or without background antifibrotics like Esbriet and Ofev. BMS-986278’s safety profile was generally well tolerated in both treatment arms, BMS said. Side effect rates were on par with the dummy drug, and discontinuation rates were low, the company added. Across placebo and both doses of the drug, the most common side effects reported were diarrhea, COVID-19, cough and difficult or labored breathing. The PPF win comes several months after BMS posted positive phase 2 results on its drug candidate in IPF. In May, the company reported that a 60-mg dose of BMS-986278 reduced the rate of decline 62% on a measure of ppFVC. The company found that the 30-mg dose was not effective on the same measure. Given that phase 2 success, BMS plans to begin work on a phase 3 program, the company’s chief medical officer Samit Hirawat, M.D., said earlier this year. On top of Monday’s PPF win, BMS said its drug will now be assessed in the phase 3 ALOFT (An LPA1 antagonistLPA1 antagonist for pulmonary Fibrosis Trial) program. In 2022, Ofev brought home full-year sales of 3.2 billion euros (about $3.4 billion). Esbriet, for its part, started to suffer from the entry of generics in last year’s second quarter, Roche said in a recent earnings release. The drug posted (PDF) full-year 2022 sales of 718 million Swiss francs (roughly $805 million). Ofev is patent protected until 2029.