Pliant Therapeutics Q2 2024 Financial Results and Corporate Update

Positive data from a 12-week Phase 2a PET imaging trial demonstrated reduced total lung collagen, improved FVC and reduced cough severity in IPF patients treated with bexotegrast.

Positive long-term data from INTEGRIS-PSC 320 mg dose group demonstrated bexotegrast was well tolerated with continued antifibrotic and anti-cholestatic activity observed at 24 weeks across multiple measures.

BEACON-IPF Phase 2b trial on track for full enrollment in the first quarter of 2025 with data anticipated in mid-2026.

Pliant Therapeutics, a leading biotechnology firm specializing in treatments for fibrotic diseases, has delivered a corporate update and financial results for the second quarter of 2024. Pliant's primary therapeutic candidate, bexotegrast, continues to show promising results across multiple studies involving idiopathic pulmonary fibrosis (IPF) and primary sclerosing cholangitis (PSC).

Recent data from a 12-week Phase 2a PET imaging trial of bexotegrast in IPF patients revealed significant improvements. Administered at a daily dose of 160 mg, the treatment was well tolerated and led to a reduction in total lung collagen, improved forced vital capacity (FVC), and reduced cough severity. This double-blind, placebo-controlled trial underlines bexotegrast's potential to reverse fibrosis in IPF patients.

The BEACON-IPF trial, a pivotal Phase 2b/3 study, is currently underway. It aims to evaluate the effects of daily doses of 160 mg or 320 mg of bexotegrast over 52 weeks. This study involves 360 IPF patients and is expected to complete enrollment by the first quarter of 2025, with data anticipated by mid-2026.

Additional positive long-term data emerged from the INTEGRIS-PSC trial, which focused on the 320 mg dose group. Bexotegrast demonstrated continued antifibrotic and anti-cholestatic activity over 24 weeks, with sustained tolerance observed up to 40 weeks. Notable improvements included a reduction in liver stiffness, significant decreases in alkaline phosphatase (ALP) levels, and enhanced hepatocyte function and bile flow.

Pliant Therapeutics has also been advancing other pipeline programs. The Phase 1 trial of PLN-101095 in solid tumors is progressing, with the third of five cohorts currently being dosed. PLN-101095 is a small molecule inhibitor targeting integrins αvβ8 and αvβ1 to block TGF-β activation in tumor microenvironments. Preliminary data from this trial is expected by late 2024 or early 2025.

Another candidate, PLN-101325, is in development for treating muscular dystrophies. This monoclonal antibody acts as an allosteric agonist of integrin α7β1. Preclinical data suggest it may also be effective in treating conditions outside of muscle tissue. The company is gathering additional evidence before initiating a Phase 1 trial.

On the corporate front, Pliant Therapeutics appointed Steve Krognes to its Board of Directors. Krognes brings over three decades of financial and strategic experience in life sciences.

Financially, the second quarter saw research and development expenses rise to $45.6 million, up from $33.0 million in the previous year, primarily due to the BEACON-IPF study. General and administrative expenses also increased slightly to $15.0 million. The net loss for the quarter was $55.9 million, compared to $41.2 million in the same period last year. As of June 30, 2024, the company held cash, cash equivalents, and short-term investments totaling $438.1 million.

Pliant Therapeutics remains committed to its mission of developing novel therapies for fibrotic diseases, with bexotegrast leading the charge in both IPF and PSC treatments. The company's robust clinical pipeline and strategic leadership position it well for future advancements and potential market breakthroughs.