Shares of Pliant Therapeutics Inc. (PLRX), which touched an all-time low of $19.50 on Oct.2, 2020, have since gained 49%.
Pliant Therapeutics is a clinical stage biopharmaceutical company developing novel therapies for the treatment of fibrosis diseases. It was on this day, last year, i.e., June 3, 2020, that the company went public on the Nasdaq Capital Market by setting a public offering at $16 per share. However, the stock opened the first day of trading at $25 and closed at $21.30 that day.
The lead compound of Pliant is PLN-74809, a small-molecule, dual selective inhibitor of aVß1/aVß6 for the treatment of idiopathic pulmonary fibrosis and primary sclerosing cholangitis.
Idiopathic pulmonary fibrosis (IPF) is a serious chronic disease that affects the tissue surrounding the air sacs, or alveoli, in the lungs. The median survival of IPF patients is 3 to 5 years.
There are only two FDA-approved drugs for the treatment of idiopathic pulmonary fibrosis – Boehringer Ingelheim’s Ofev and Roche’s Esbriet.
Pliant’s PLN-74809 is under a phase IIa trial in idiopathic pulmonary fibrosis, dubbed INTEGRIS-IPF. Initiated in March 2020, INTEGRIS-IPF is designed to enroll 84 subjects and is on track to complete enrollment by the end of this year.
A phase IIa trial, which utilizes positron emission tomography (PET), to confirm the ability of PLN-74809 to penetrate highly fibrotic areas of the lung where avß6 expression is highest and binds to its target receptor is underway. Preliminary data from this trial is anticipated in the first half 2021.
The second indication in which PLN-74809 is being tested is Primary Sclerosing Cholangitis.
Primary Sclerosing Cholangitis (PSC) is a progressive inflammatory liver disease resulting in scarring of bile ducts, and cirrhosis, for which there are currently no FDA approved therapeutics. The median survival of PSC patients is 10-12 years without intervention.
A phase IIa trial of PLN-74809 in primary sclerosing cholangitis, dubbed INTEGRIS-PSC, is ongoing, with enrollment planned for completion in the first half 2022.
Pliant is also exploring the potential of PLN-74809 in COVID-19. A phase IIa trial of PLN-74809 in subjects with Acute Respiratory Distress Syndrome (ARDS) associated with at least severe COVID-19, initiated last October, is underway.
Another clinical program of Pliant is PLN-1474, a small molecule selective inhibitor of avß1, targeting liver fibrosis associated with nonalcoholic steatohepatitis (NASH).
In October 2019, Pliant and Novartis entered into a Collaboration and License Agreement for the development and commercialization of PLN-1474 and up to three integrin research targets.
A phase I trial of PLN-1474 in 84 healthy volunteers, which was a safety, tolerability, and pharmacokinetics dose-escalating first-in-human study, was successfully completed in March of this year.
Following successful completion of the phase I trial by Pliant, Novartis has now taken up the responsibility for all future development, manufacturing, and commercialization activities of PLN-1474.
As part of the 2019 agreement, Pliant received $80 million up-front, including $50 million license fee and $30 million equity. Pliant is eligible to receive milestone payments of up to $416 million, of which $25 million has been received to date.
The company also has two preclinical programs targeting oncology and muscular dystrophies.
The company’s cash balance as of March 31, 2021, totaled $264 million, which is expected to be sufficient to fund its operations into 2023.
PLRX has thus far hit a low of $19.42 and a high of $43.92. The stock closed Wednesday’s trading at $29.07, down 4.47%.
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