预约演示
With 2nd phase 2 win, Bristol Myers Squibb builds case for first-in-class contender in pulmonary fibrosis
2023-09-11
临床结果临床2期临床3期临床1期
Bristol Myers Squibb is sharing its phase 2 results at the European Respiratory Society 2023 international congress this week.
Bristol Myers Squibbore common form of pulmonary fibrosis in May, Bristol Myers Squibb’s lysophosphatidic acid receptor 1 (LPA1) antagonist has turned out positive results in a rarer incarnation of the disease. The clinical win ups the pressure on a pair of entrenched blockbusters in interstitial lung disease—Roche’s Esbriet and Boehringer Ingelheim’s Ofev.
Angling for the first-in-class title, Bpulmonary fibrosisl LPA1 anBristol Myers Squibbtrilysophosphatidic acid receptor 1 (LPA1) antagonistlysophosphatidic acid receptor 1 (LPA1)ith 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 interstitial lung diseaseaRocheof lung functioBoehringer IngelheimPF—by 69% versus placebo.
BMS is sharing the results at the European Respiratory Society 2023 internaBMS-986278gress this week.progressive pulmonary fibrosis (PPF)PPF
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 druRocheld pirfenidoneial as an add-onEsbrietablished therapiesnintedanib
BMS-986278fibrosis occurs when the lung pulmonary fibrosisaged and scarred. The disease is characterized by shortness of breath, coughing and fatigue. PPF is less common than its sibling idiopathic pulmonary fibrosis (IPF), though PPF has shown a similar prognosis to IPF. Both diseases are fatal, with a median survival time of three to five years and a five-year survival rate of roughly 45%, BMS said in a press release.
Pulmonary fibrosisudy, parallel cohorts of IPF and PPF patients received 30 mg or 60 mg of the company’s LPAshortness of breathilcoughing6 weefatiguePPFidiopathic pulmonary fibrosis (IPF)PPFIPF
However, BMS noted that across doses, treatment was consistent with or without background antifibrotics like Esbriet and Ofev.
BMS-986278cebo and both doses of the drug, the most common side effects reported were diarrhea, COVID-19, cough and difficult or labored breathing.
In May, the company reported that a 60-mg dose of BMS-986278 reduced the rate of decline 62% on a meIPFre 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 worBMS-986278se 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 antagonist for pulmonary Fibrosis Trial) program.
Both Roche’s and Boehringer’s entrenched antifibrotics have ginned up blockbuster sales over the years.LPA1pulmonary Fibrosis
In 20Rochefev broBoehringerfull-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.
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