BMS Receives the US FDA’s Breakthrough Designation for BMS-986278 to Treat Pulmonary & Progressive Pulmonary Fibrosis (IPF & PPF)
- The designation was granted based on the results from the P-II clinical trial evaluating the safety & efficacy of BMS-986278 (30/60mg, BID) vs PBO for 26wks. in patients with IPF & PPF. The rate of change in ppFVC from baseline to 26wks. was evaluated as 1EP in IPF cohort & as 2EP in PPF cohort
- As per the results, a 69% relative reduction in the rate of change in ppFVC vs PBO was seen in the PPF cohorts receiving BMS-986278 (60mg, BID) with treatment effects consistent with/out background therapy & rates of AEs similar to PBO. The results were presented at the ESR 2023
- BMS-986278 is an oral small molecule LPA1 antagonist that is being evaluated as an antifibrotic for the treatment of IPF & PPF
Ref: Businesswire | Image: BMS
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