Pliant Therapeutics has captured the attention of investors with compelling early clinical findings regarding its lead drug candidate’s potential to alleviate scarring and itching in a chronic liver ailment. This development led to a notable surge of approximately 15% in the company’s share price. The focus of interest is bexotegrast, an oral, dual-selective inhibitor of two integrins, currently undergoing evaluation in a phase 2a trial against a placebo in patients grappling with primary sclerosing cholangitis (PSC) and suspected liver fibrosis. PSC is a condition devoid of FDA-approved treatment options, characterized by the scarring of bile ducts and the onset of cirrhosis. By specifically inhibiting TGF-β in the liver tissue, bexotegrast has emerged as a prospective therapeutic solution for PSC.
While the primary objectives of the phase 2a trial revolve around evaluating safety, tolerability, and pharmacokinetics, Pliant has also ventured into assessing exploratory efficacy endpoints. These include monitoring alterations in liver fibrosis, biochemical markers, and imaging. The preliminary findings from these exploratory endpoints have offered early indications that bexotegrast could yield favorable outcomes.
Following 12 weeks of dosing, the ELF score, a blood test measuring fibrosis markers, exhibited a significant reduction in the high-dose cohort (160 mg) compared to the placebo group, with noteworthy decreases observed across all bexotegrast arms. Pliant attributed the high dose to an impressive 84% reduction relative to the placebo. This reduction was supported by substantial declines in all three components constituting the ELF score. Additionally, Pliant reported a noteworthy decrease in collagen synthesis and a reduction in itchiness, particularly in the high-dose group. Other liver biochemical and imaging parameters also favored bexotegrast, bolstering the company’s data, which prompted a substantial increase in its share price to approximately $16.60 during premarket trading.
It’s important to note that while these findings are promising, the dataset remains relatively small, with each arm comprising approximately 20 patients. Nevertheless, the observed efficacy signals coupled with the absence of safety concerns have instilled confidence in Pliant and its investors. Attention now turns to the eagerly anticipated release of 12-week data related to a higher 320-mg dose, scheduled for the first quarter of the upcoming year.
Pliant is part of a select group of biotechnology companies dedicated to addressing the unmet needs in PSC, a condition that has previously eluded the development of an FDA-approved treatment, despite efforts by companies like Gilead Sciences. This current cohort of companies striving to tackle this liver condition includes Chemomab Therapeutics, Dr. Falk Pharma, Escient Pharmaceuticals, HighTide Therapeutics, and Mirum Pharmaceuticals, collectively working towards finding a solution for this challenging medical condition.