Pliant Therapeutics Announces Major Workforce Reduction Following Bexotegrast Trial Setback

Pliant Therapeutics, a California-based biotech company, has announced a significant restructuring of its workforce, cutting 45% of its staff. This drastic measure comes in the wake of safety concerns that led to the discontinuation of the company's Phase 2b/3 Beacon-IPF trial for bexotegrast, its lead asset for idiopathic pulmonary fibrosis (IPF).

Trial Discontinuation and Safety Concerns

The decision to halt the Beacon-IPF trial was made in March after an independent Data Safety Monitoring Board (DSMB) and an external expert panel identified an "imbalance in unadjudicated IPF-related adverse events between the treatment and placebo groups." Despite evidence of efficacy, the safety issues were deemed significant enough to warrant the trial's termination.

Bexotegrast, an oral, small molecule, dual-selective inhibitor of the αvβ6 and αvβ1 integrins, had shown promise in treating IPF. However, the company now faces the challenge of reassessing the drug's future development path.

Strategic Restructuring and Financial Implications

The workforce reduction is part of Pliant's efforts to preserve cash and extend its financial runway. As of its March quarterly results presentation, the company reported $357.2 million in cash, which it had stated was "sufficient to fund operations for the next 12 months and beyond."

Bernard Coulie, M.D., Ph.D., president and CEO of Pliant, commented on the restructuring: "Today's actions, while difficult, provide us the flexibility to prepare for, and execute on our mission to make a difference in the lives of patients." He also expressed gratitude to the employees affected by the cuts for their contributions to the company's mission.

Future Plans and Pipeline

While the company plans to review the full topline data from the Beacon-IPF trial in the second quarter, it is already considering potential next steps for bexotegrast's development. These may include additional dose-ranging Phase 2b studies with lower doses in pulmonary fibrosis and exploration of non-respiratory indications, such as liver diseases.

Pliant emphasized that despite the cuts affecting all departments, it aims to maintain its "strong late-stage clinical trial execution capability." The company's pipeline also includes several less advanced assets, such as PLN-101095 for cancer and the Phase 1-ready PLN-101325 for muscular dystrophies.

As the biotech industry closely watches Pliant's next moves, the company's stock saw a modest 1.2% increase in after-hours trading following the announcement, with a market capitalization of $99 million.