On August 9, 2023 Pliant Therapeutics, Inc. (Nasdaq: PLRX), a clinical stage biotechnology company focused on discovering and developing novel therapeutics for the treatment of fibrosis, reported a corporate update and provided second quarter 2023 financial results (Press release, Pliant Therapeutics, AUG 9, 2023, View Source [SID1234634087]).

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"We are extremely pleased with the continued progress in the second quarter across the portfolio, including positive long-term data from our INTEGRIS-IPF Phase 2a trial of bexotegrast in IPF, as well as the entry of our third drug candidate, PLN-101095, into Phase 1 testing for treatment of solid tumors. Our team’s strong execution over the quarter positions us well for multiple expected milestones throughout the remainder of the year, including the recent initiation of BEACON-IPF, our Phase 2b trial in IPF, and an upcoming interim Phase 2a data readout from INTEGRIS-PSC which is expected in the third quarter," said Bernard Coulie, M.D., Ph.D., President and Chief Executive Officer of Pliant Therapeutics.

Second Quarter and Recent Highlights

Bexotegrast Highlights

•BEACON-IPF, a Phase 2b trial of bexotegrast in patients with IPF, has been initiated. BEACON-IPF is a 52-week, multinational, randomized, dose-ranging, double-blind, placebo-controlled trial evaluating bexotegrast at once-daily doses of 160 mg or 320 mg. BEACON-IPF is expected to enroll approximately 270 patients with IPF.
•INTEGRIS-IPF Phase 2a 24-week 320 mg clinical data showed bexotegrast was well tolerated and demonstrated durable improvements in exploratory efficacy endpoints. Phase 2a 24-week data from the 320 mg dose cohort showed bexotegrast was well tolerated up to 40 weeks, displayed a favorable pharmacokinetic profile and showed durable improvements in forced vital capacity (FVC), Quantitative Lung Fibrosis (QLF) imaging, patient reported cough severity and fibrosis biomarkers in patients with idiopathic pulmonary fibrosis (IPF).
•INTEGRIS-PSC Phase 2a 12-week interim data expected in the third quarter of 2023. INTEGRIS-PSC is a randomized, dose-ranging, double-blind, placebo-controlled trial evaluating the safety, tolerability and pharmacokinetics of bexotegrast in patients with primary sclerosing cholangitis (PSC). Exploratory efficacy endpoints include fibrosis biomarkers such as PRO-C3 and enhanced liver fibrosis (ELF) score, changes in alkaline phosphatase (ALP), and liver imaging. Interim 12-week data from approximately 84 patients in the 40, 80 and 160 mg cohorts is expected in the third quarter of 2023.
•INTEGRIS-PSC 320 mg dose cohort enrollment complete with interim 12-week data expected in the first quarter of 2024. This trial is evaluating the safety, tolerability and pharmacokinetics of bexotegrast at 320 mg versus placebo at 12 and 24 weeks of treatment in approximately 28 patients with PSC. The trial is also evaluating exploratory efficacy endpoints including fibrosis biomarkers such as serum PRO-C3 and ELF score, changes in ALP and liver imaging. The final 24-week data is expected in mid-2024.
Pipeline Programs
•Phase 1 trial of PLN-101095 in solid tumors recruiting. A Phase 1 open label trial of PLN-101095, an oral, small-molecule, dual selective inhibitor of αvβ8 and αvβ1 integrins designed to block TGF-β activation in the tumor microenvironment, was initiated in the second quarter. This trial is recruiting patients with solid tumors that are resistant to immune checkpoint inhibitors.
•Muscular dystrophy program progressing through IND enabling activities. PLN-101325 is a monoclonal antibody designed to act as an allosteric agonist of the α7β1 integrin. An IND submission for PLN-101325 for Duchenne muscular dystrophy (DMD) is expected in the first quarter of 2024.
Corporate Highlights
•Scott Turner, Ph.D. promoted to Chief Scientific Officer. The Company is announcing the promotion of Dr. Scott Turner to the role of Chief Scientific Officer. Dr. Turner joined Pliant in 2016 and most recently served as the Company’s Senior Vice President of Research. In his new role, Dr. Turner will oversee all early stage drug discovery initiatives and manage the Company’s development portfolio.
Second Quarter 2023 Financial Results
•Research and development expenses were $33.0 million, as compared to $26.3 million for the prior-year quarter. The increase was due primarily to employee related expenses and increased clinical and manufacturing-related costs associated with our lead program, bexotegrast, partially offset by a decrease in preclinical manufacturing costs for our pipeline product candidates.
•General and administrative expenses were $14.6 million, as compared to $8.3 million for the prior-year quarter. The increase was due to higher personnel-related expenses.
•Net loss of $41.2 million as compared to $29.5 million for the prior-year quarter due to an increase in operating expenses coupled with a decrease in collaboration revenues under the Novartis collaboration during the quarter.
•As of June 30, 2023, the Company had cash, cash equivalents and short-term investments of $555.2 million which the Company expects to be sufficient to fund operations into the second half of 2026.