The BEACON-IPF Phase 2b trial, which was assessing bexotegrast in patients with idiopathic pulmonary fibrosis (IPF), has been discontinued by Pliant Therapeutics, Inc. after a predetermined data review and recommendation by the independent Data Safety Monitoring Board (DSMB) of the trial and a secondary review and recommendation by an external expert panel. Early evidence of benefit on the forced vital capacity (FVC) endpoint was also noted, although the trial was terminated due to an imbalance in unadjudicated IPF-related adverse events between the treatment and placebo groups.
The first late-stage IPF trial to be terminated for safety while having compelling efficacy data is BEACON-IPF.
In BEACON-IPF, the average exposure time was almost 17 weeks. Overall, there were about 10% of IPF-related adverse events in both dosage groups, which is comparable. The low (less than 3%) occurrence of IPF-related adverse events in the placebo group seems to have been the primary cause of the imbalance between the active and placebo groups. In contrast, IPF-related adverse events were similar among persons treated with bexotegrast (7%) at all doses and placebo (10%) in the Phase 2a INTEGRIS-IPF trial (mean exposure period of roughly 16 weeks).
The company intends to assess the BEACON-IPF trial’s full data and determine the best course of action for bexotegrast’s development. The company will take into consideration more dose-ranging Phase 2b studies with lower doses in pulmonary fibrosis and possibly other non-respiratory indications, such as liver diseases, after the complete analysis is finished, which should give a better understanding of the benefit risk profile and therapeutic window of bexotegrast.
Source: Pliant Therapeutics
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