Bristol Myers Squibb (BMS) will continue investigating BMS-986278 in a global Phase III trial program in patients with idiopathic pulmonary fibrosis (IPF) following positive data from a Phase II trial. The investigational drug is a first-in-class lysophosphatidic acid receptor 1 (LPA1) antagonist for the treatment of pulmonary fibrosis.

Dr Samit Hirawat, chief medical officer at BMS, said that the Phase II data gives the company great confidence to initiate a global Phase III clinical trial program to continue investigating BMS-986278 in patients with IPF. According to BMS’s Q4 2022 financial report, the company expects to initiate the Phase III trial in 2023.

The data showed that a 60mg dose led to a 62% relative reduction in the rate of change in percent predicted forced vital capacity (ppFVC) compared to placebo in the while-on-treatment analysis. Additionally, BMS-986278 demonstrated a 54% reduction compared to the placebo in the treatment policy analysis.

BMS used a prespecified Bayesian analysis to provide a probability of a positive treatment difference for BMS-986278 compared to the placebo. The Bayesian analysis showed a greater than 95% probability that the 60mg dose was superior compared to the placebo in reducing the decline rate in ppFVC over 26 weeks in both the while-on-treatment and treatment policy estimands. The 30mg dose was deemed not effective compared to placebo.

The primary endpoint measured the rate of change in ppFVC from baseline over 26 weeks. The primary outcome assessment was based on two prespecified estimands, while-on-treatment and treatment policy estimands.

The while-on-treatment estimand included all observed data prior to dose reduction, which was offered to patients who met the prespecified blood pressure criteria. It provided an estimate of efficacy without dose reduction as part of the treatment regimen. The treatment policy estimand included all observed data regardless of dose reduction and provided an estimate of efficacy with dose reduction as part of the treatment regimen.

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The data analysis showed that BMS-986278 was well tolerated with rates of adverse events, including gastrointestinal side effects and treatment discontinuation compared to the placebo. In the placebo, 30mg, and 60mg dose arms, adverse events (AEs) occurred in 80%, 76%, and 74% of the patients, respectively. Serious AEs occurred in 17%, 11% and 11% of the patients, respectively.

The Phase II trial (NCT04308681) dosed 276 patients with either 30mg, 60mg or matching placebo orally twice daily. Two-thirds of the patients were on background antifibrotic therapy during the trial. The 10mg dose reductions were implemented in 5% of the placebo cohort, 8% in the 30mg group, and 6% in the 60mg dose arm.

IPF is an interstitial lung disease that occurs when lung tissue becomes damaged and scarred, with more than 700,000 adults living with the condition. A GlobalData competitive landscape report estimates that in 2028 the highest diagnosed prevalent cases of IPF will be in China and India.