On May 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 announced first quarter 2023 financial results (Press release, Pliant Therapeutics, MAY 9, 2023, View Source [SID1234631287]).
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"So far in 2023 we have made significant progress in advancing the portfolio including positive 12- and 24-week data readouts from our INTEGRIS-IPF trial and a successful follow-on offering that extended our expected operating runway into the second half of 2026," said Bernard Coulie, M.D., Ph.D., President and Chief Executive Officer of Pliant Therapeutics. "With clinical data and development milestones expected throughout the remainder of 2023, including Phase 2a data from INTEGRIS-PSC and initiation of our BEACON-IPF Phase 2b and our oncology Phase 1 trials, we look forward to building upon an already productive year."
First Quarter and Recent Highlights
Bexotegrast (PLN-74809) Highlights
•INTEGRIS-IPF Phase 2a 24-week 320 mg clinical data showed bexotegrast was well tolerated and demonstrated durable improvements in exploratory endpoints. This 24-week Phase 2a data from the 320 dose group showed bexotegrast was well tolerated up to 40 weeks, displayed a favorable pharmacokinetic profile and in exploratory efficacy endpoints showed improvements in forced vital capacity (FVC), Quantitative Lung Fibrosis (QLF) imaging, patient reported cough severity and biomarkers in patients with idiopathic pulmonary fibrosis (IPF) to Week 24. In January, 12-week data from the 320 mg dose group showed bexotegrast demonstrated statistically significant FVC increases at all time points, was well tolerated with no drug-related severe or serious adverse events and showed dose-proportional increases in plasma concentrations, consistent with prior dose groups.
•Initiation of BEACON-IPF, a Phase 2b trial of bexotegrast in patients with IPF, expected in mid-2023. BEACON-IPF is a 52-week, multinational, randomized, placebo-controlled trial evaluating bexotegrast at doses of 160 mg or 320 mg in approximately 270 patients with IPF.
•INTEGRIS-PSC Phase 2a 12-week clinical data expected in the third quarter of 2023. INTEGRIS-PSC is a 12-week randomized, dose-ranging, double-blind, placebo-controlled trial evaluating safety, tolerability and pharmacokinetics of bexotegrast at doses of 40, 80 or 160 mg in approximately 84 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. INTEGRIS-PSC is fully enrolled.
•First patient dosed in the INTEGRIS-PSC Phase 2a 320 mg dose cohort, evaluating bexotegrast for at least 24 weeks. This cohort is evaluating the safety, tolerability and pharmacokinetics of bexotegrast at a dose of 320 mg versus placebo over at least 24 weeks of treatment in approximately 28 patients with PSC. The trial is also evaluating exploratory efficacy endpoints including fibrosis biomarkers such as PRO-C3 and ELF score, changes in ALP and liver imaging.
Early-Stage Development Programs
•Initiation of a Phase 1 first-in-human trial of PLN-101095 in oncology expected in the second quarter of 2023. PLN-101095 is an oral, small molecule, dual selective inhibitor of αvβ8 and αvβ1 integrins designed to block TGF-β activation in the tumor microenvironment. Initiation of a Phase 1 trial in patients with solid tumors that are resistant to immune checkpoint inhibitors is expected in the second quarter of 2023.
•Muscular dystrophy program progressing through IND enabling activities. PLN-101325 is a monoclonal antibody designed to act as an allosteric agonist of the integrin α7β1. An IND submission for Duchenne muscular dystrophy (DMD) is expected in 2023.
Corporate Highlights
•Closing of underwritten public offering of $287.5 million in common stock. The Company closed a public offering in January 2023, yielding $269.9 million in net proceeds to the Company, which included the underwriter’s exercise in full of their option to purchase additional shares.
First Quarter 2023 Financial Results
•Research and development expenses were $29.3 million, as compared to $20.9 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 $14.2 million, as compared to $8.6 million for the prior-year quarter. The increase was due to higher personnel-related and professional services expenses.
•Net loss of $37.5 million as compared to $28.1 million for the prior-year quarter due to an increase in operating expenses coupled with a slight decrease in collaboration revenues under the Novartis collaboration during the quarter.
•As of March 31, 2023, the Company had cash, cash equivalents and short-term investments of $577.3 million, which the Company expects to be sufficient to fund operations into the second half of 2026.