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SOUTH SAN FRANCISCO - Pliant Therapeutics, Inc. (NASDAQ:PLRX) today announced encouraging results from a Phase 2a clinical trial for bexotegrast, a drug candidate for the treatment of primary sclerosing cholangitis (PSC), a rare liver disease. The 24-week data from the trial indicated that the 320 mg dosage of bexotegrast was well tolerated with no severe or serious adverse events related to treatment.

The trial, named INTEGRIS-PSC, was a double-blind study involving 121 patients with suspected moderate to severe liver fibrosis due to PSC. It aimed to assess the safety and efficacy of bexotegrast, which met its primary safety endpoint.

Moreover, patients treated with bexotegrast showed improvement in liver stiffness measurements and a statistically significant reduction in alkaline phosphatase (ALP) levels over 24 weeks compared to those on placebo.

The exploratory efficacy endpoints included changes in liver stiffness as measured by transient elastography, liver fibrosis markers such as the Enhanced Liver Fibrosis (ELF) score, liver biochemistry, and magnetic resonance imaging (MRI). The findings suggested that bexotegrast may stabilize liver fibrosis, with further improvement in hepatocyte function and bile flow observed between weeks 12 and 24.

Pliant's Chief Medical Officer, Éric Lefebvre, expressed optimism about the trial's findings, which also showed lower occurrences of pruritus and cholangitis—symptoms associated with PSC—in the bexotegrast group compared to placebo.

Following discussions with the U.S. Food and Drug Administration (FDA), Pliant is planning a 52-week, dose-ranging Phase 2b trial with non-invasive endpoints to further evaluate bexotegrast's potential in PSC treatment. Currently, there are no FDA or European Medicines Agency-approved therapies for PSC, highlighting the urgent need for effective treatment options for this progressive liver disease.

The company extended its gratitude to the trial participants, their families, and the study teams for their contribution to this research. This announcement is based on a press release statement from Pliant Therapeutics.

In other recent news, Pliant Therapeutics has been making significant strides in its clinical trials and research. The company's investigational drug, bexotegrast, has shown promising results in treating idiopathic pulmonary fibrosis (IPF), according to recent studies. The drug demonstrated a reduction in lung collagen, improvements in forced vital capacity, and decreased cough severity in patients.

Piper Sandler, Oppenheimer, RBC Capital, and Stifel have all maintained positive ratings for Pliant Therapeutics, highlighting the company's potential in the IPF space. Piper Sandler confirmed its Overweight rating and $40.00 stock price target, while Oppenheimer reiterated an Outperform rating and a price target of $48.00. RBC Capital maintained its Outperform rating with a steady price target of $45.00, and Stifel reaffirmed its Buy rating.

Further developments for Pliant Therapeutics include the release of the 24-week Phase 2a INTEGRIS-PSC data and a meeting with the FDA, both expected around mid-2024. The completion of enrollment for the Phase 2b/3 BEACON-IPF study is guided for the first quarter of 2025. These recent developments underscore the company's commitment to advancing treatments for fibrotic diseases.

InvestingPro Insights

Pliant Therapeutics, Inc. (NASDAQ:PLRX) has shared promising results from its Phase 2a clinical trial, which could have a significant impact on its future financial performance and market valuation. To provide investors with a deeper understanding of the company's financial health and stock performance, here are some key metrics and tips from InvestingPro:

InvestingPro Data:

• Market Cap (Adjusted): 769.15M USD, reflecting the company's current valuation in the market.

• P/E Ratio (Adjusted) last twelve months as of Q1 2024: -4.5, indicating that investors are willing to pay $4.50 for a dollar of PLRX's losses, which could be due to expectations of future growth.

• Revenue last twelve months as of Q1 2024: 0.25M USD, which is critical to monitor as the company progresses with its clinical trials and potential product commercialization.

InvestingPro Tips:

• PLRX holds more cash than debt on its balance sheet, which is a positive sign for the company's financial stability as it continues to invest in clinical trials.

• The company is not expected to be profitable this year, which is an essential consideration for investors looking at the long-term earning potential of PLRX.

For investors seeking more in-depth analysis, there are additional InvestingPro Tips available for Pliant Therapeutics. By using the coupon code PRONEWS24, investors can get up to 10% off a yearly Pro and a yearly or biyearly Pro+ subscription to access exclusive insights. Currently, there are 8 additional tips listed on InvestingPro (https://www.investing.com/pro/PLRX) that can provide further guidance on the investment potential of PLRX.

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