Pliant Therapeutics Updates and Q1 2024 Financial Results

Pliant Therapeutics, Inc., a late-stage clinical biotechnology firm, recently announced advancements in its portfolio along with its first quarter financial results for 2024. The company, recognized for its work in developing treatments for fibrotic diseases, has made notable strides in several ongoing clinical trials and pipeline programs.

Significant achievements have been made in the development of bexotegrast, the company’s lead product candidate. BEACON-IPF, a pivotal, adaptive Phase 2b/3 trial, has been implemented to accelerate bexotegrast’s development for idiopathic pulmonary fibrosis (IPF). The adaptive trial design, approved by European and other global health authorities, is expected to shorten the time to obtain Phase 3 data by up to two years. The Phase 2b portion of the BEACON-IPF trial has been expanded from 267 to 360 patients, with enrollment anticipated to be complete by the first quarter of 2025.

In addition to the BEACON-IPF trial, a 12-week Phase 2a PET imaging trial investigating bexotegrast’s impact on total lung collagen and forced vital capacity (FVC) in IPF patients has been concluded. This randomized, double-blind, placebo-controlled study was conducted at Massachusetts General Hospital, focusing on changes in total lung collagen using PET imaging. The trial also examined safety, tolerability, and several exploratory endpoints, including FVC changes, cough severity, and fibrosis biomarkers. Topline data from this study are expected imminently.

The company also completed the INTEGRIS-PSC Phase 2a trial, which evaluated bexotegrast in patients with primary sclerosing cholangitis (PSC). The trial demonstrated that bexotegrast at a 320 mg dose was well tolerated over 12 weeks with no severe or serious adverse drug-related events. The treatment showed promising reductions in Enhanced Liver Fibrosis (ELF) scores and improvements in liver function and bile flow. The final 24-week data from this cohort is expected by mid-2024.

Pliant Therapeutics has also advanced its muscular dystrophy program, PLN-101325, after receiving regulatory clearance for a Phase 1 clinical study. This monoclonal antibody aims to treat muscular dystrophies, including Duchenne muscular dystrophy (DMD). In addition, the Phase 1 trial of PLN-101095, an oral inhibitor designed for treating solid tumors, is progressing with the third of five cohorts currently being enrolled. Preliminary data from this trial could be available by late 2024.

Financially, Pliant Therapeutics strengthened their capital position through an upsized loan facility with Oxford Finance LLC, securing up to $150 million of non-dilutive capital. As of March 31, 2024, the company reported cash, cash equivalents, and short-term investments totaling $483.9 million, which are expected to support their operations through 2026.

For the first quarter of 2024, the company reported research and development expenses of $37.1 million, an increase from $29.3 million in the prior year, primarily due to higher employee-related costs and increased clinical and manufacturing expenses for bexotegrast. General and administrative expenses were also higher at $15.2 million, compared to $14.2 million in the previous year, mainly due to increased employee-related costs. The net loss for the quarter stood at $47.0 million, compared to $37.5 million in the same period last year, attributed to higher operating expenses and reduced collaboration revenues.

Overall, Pliant Therapeutics continues to make considerable progress in its clinical programs and maintains a strong financial position to support its ongoing and future initiatives in developing treatments for fibrotic diseases.