CHEST Guidelines-Randomized,-Double-Blind,-Placebo-Controlled,-Phas

Randomized,-Double-Blind,-Placebo-Controlled,-Phas

Pdf Summary

The phase 2 clinical trial explored the safety and efficacy of BMS-986020, a lysophosphatidic acid receptor 1 (LPA1) antagonist, for treating idiopathic pulmonary fibrosis (IPF). Conducted as a randomized, double-blind, placebo-controlled trial, it involved 143 patients with IPF. Participants received either a placebo or 600 mg of BMS-986020, administered once or twice daily over 26 weeks. The primary endpoint focused on the change in forced vital capacity (FVC) from baseline to week 26.<br /><br />Results showed that patients receiving BMS-986020 twice daily experienced a significantly slower decline in FVC than those on the placebo, signaling a potential benefit in slowing disease progression. However, some patients in both active treatment groups showed dose-related increases in liver enzymes. The study ended prematurely due to three cases of cholecystitis linked to BMS-986020.<br /><br />The trial also evaluated secondary outcomes like the effects on lung fibrosis scores, 6-minute walk distance, diffusing capacity for carbon monoxide (DLCO), and dyspnea. While no significant differences were observed between the treatment groups and placebo in these areas, the rate of FVC stabilization was higher in patients receiving BMS-986020.<br /><br />Safety concerns such as cholecystitis and elevated liver enzymes were critical factors in the trial's early termination. Despite these safety issues, the trial's results encouraged further research into LPA1 antagonists for IPF due to potential benefits in slowing disease progression.<br /><br />The trial, funded by Bristol-Myers Squibb, highlights the need for more therapeutic options beyond current treatments like pirfenidone and nintedanib, which only slow IPF progression. The study suggested the promising potential of targeting LPA1 in managing IPF, meriting additional research despite the associated risks.

Keywords

BMS-986020

idiopathic pulmonary fibrosis

LPA1 antagonist

clinical trial

forced vital capacity

cholecystitis

liver enzymes

disease progression

safety concerns

therapeutic options