On Monday, Pliant Therapeutics Inc. (NASDAQ:PLRX) announced that it would discontinue the BEACON-IPF Phase 2b trial, which evaluated bexotegrast in patients with idiopathic pulmonary fibrosis (IPF).
The move follows a prespecified data review and recommendation by the trial’s independent Data Safety Monitoring Board (DSMB) and a secondary review and recommendation by an outside expert panel.
While an imbalance in unadjudicated IPF-related adverse events between the treatment and placebo groups led to the discontinuation of the trial, early evidence of efficacy on the forced vital capacity (FVC) endpoint was also observed.
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The mean exposure duration in BEACON-IPF was approximately 17 weeks.
Overall, the percentage of IPF-related adverse events in both dose groups was comparable (approximately 10%). The imbalance between active and placebo appears to have been driven by a low (below 3%) IPF-related adverse event rate in the placebo group.
In the Phase 2a INTEGRIS-IPF trial, IPF-related adverse events were comparable in bexotegrast-treated (7%) across all doses and placebo-treated (10%) participants.
The company plans to analyze the complete data from the BEACON-IPF trial and evaluate the next steps in developing bexotegrast.
Once the full analysis is completed, which should provide a better understanding of the benefit-risk profile and therapeutic window of bexotegrast, the company will consider additional dose-ranging Phase 2b studies with lower doses in pulmonary fibrosis and potentially other non-respiratory indications, including liver diseases.
Pliant is currently enrolling the fourth of five planned dose cohorts in a Phase 1 open label dose-escalation trial of PLN-101095 as monotherapy and in combination with pembrolizumab in patients with solid tumors that are resistant to immune checkpoint inhibitors.
Interim data from the first three cohorts is expected in the first quarter of 2025.
Price Action: PLRX stock is down 51% at $1.69 at the last check Monday.
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