We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies, revised Privacy Policy and Terms of Service.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
Pliant (PLRX) Up on Success of Mid-Stage Liver Disease Study
Read MoreHide Full Article
Shares of Pliant Therapeutics, Inc. (PLRX - Free Report) gained 14.3% on Sep 26 after the company announced that its mid-stage study on lead pipeline candidate bexotegrast was successful.
The phase IIa INTEGRIS-PSC study, a randomized, dose-ranging, double-blind, placebo-controlled trial, is evaluating bexotegrast at once-daily doses of 40 mg, 80 mg, 160 mg or placebo for 12 weeks in 85 patients with primary sclerosing cholangitis (PSC).
The study enrolled 64 patients in the active arms and 21 patients in the placebo arm.
The primary endpoint of the INTEGRIS-PSC trial is the evaluation of the safety and tolerability of bexotegrast. The secondary endpoint is an assessment of its pharmacokinetics.
PSC, a rare, progressive liver disease of unknown origin, often occurs in the setting of inflammatory bowel disease. The disease is characterized by inflammation and fibrosis, with progressive liver and biliary damage leading to cirrhosis and liver failure.
The trial met its primary and secondary endpoints, demonstrating that the candidate was well tolerated over a 12-week treatment period and that its plasma concentrations increased with dosage.
Of the 64 patients treated with bexotegrast, 60 completed 12 weeks of treatment with no deaths or drug-related severe adverse events. The treatment-emergent adverse events that came up were mild or moderate in severity and consistent with PSC disease symptoms. Patients in the trial who had concomitant inflammatory bowel disease (IBD) saw no change in their IBD symptoms as measured by the partial Mayo Score while on treatment.
The study’s exploratory efficacy endpoints assessed changes in the liver fibrosis markers, Enhanced Liver Fibrosis (ELF) score and PRO-C3 levels, as well as liver biochemistry and magnetic resonance imaging (MRI) of the liver.
Bexotegrast was effective in reducing both ELF scores and PRO-C3 levels at week 12 at all doses relative to placebo, as observed from the results of the three initial doses evaluated. Statistically significant differences were observed at the 160 mg dose relative to placebo at week 12. The enrolled patients also showed stabilization of liver chemistry, including a dose-dependent trend in the reduction of alkaline phosphatase levels relative to placebo.
Preliminary MRI imaging results suggested improved hepatocyte function and bile flow with bexotegrast 160 mg.
The study’s success and compelling results, with bexotegrast demonstrating a favorable tolerability profile and antifibrotic activity across all doses, provide hope to this patient population, which currently lacks approved therapeutic options.
Meanwhile, Pliant has recently completed enrollment of the high-dose 320 mg cohort of the INTEGRIS-PSC phase IIa trial. The company expects to report twelve-week interim data from the 320 mg dose in the first quarter of 2024 and 24-week data is expected in mid-2024.
Bexotegrast is an oral, small-molecule, dual-selective inhibitor of αvß6 and αvß1 integrins. It is also being evaluated for the treatment of idiopathic pulmonary fibrosis (IPF). Pliant has initiated a phase IIb study, BEACON-IPF, of bexotegrast in IPF.
Bexotegrast enjoys Fast Track Designation and Orphan Drug Designation in the United States in IPF and PSC. It also obtained Orphan Drug Designation from the European Medicines Agency in IPF and PSC.
The successful development and commercialization of bexotegrast will be a significant boost for the company.
Shares of Pliant have lost 13.8% in the year so far compared with the industry’s decline of 15.9%.
Image Source: Zacks Investment Research
This apart, Pliant has also developed PLN-1474, a small-molecule, selective inhibitor of αvß1 integrin for the treatment of nonalcoholic steatohepatitis with liver fibrosis. Pliant has also initiated an early-stage study for its third clinical program, PLN-101095, a small-molecule, dual-selective inhibitor of αvß8 and αvß1 integrins that is being developed for the treatment of solid tumors.
Pliant entered into an agreement with Novartis (NVS - Free Report) for the development and commercialization of PLN-1474 and up to three additional integrin research targets in 2019.
However, on Feb 17, 2023, Novartis exercised its right to terminate the agreement as part of its new strategy to focus on a limited number of therapeutic areas. The termination took effect in April and consequently, all rights and licenses granted to Novartis, including PLN-1474, the related investigational new drug and the validated research target, were returned to Pliant.
Zacks Rank & Stocks to Consider
Pliant currently carries a Zacks Rank #3 (Hold).
Some well-placed stocks in the industry are Eton Pharmaceuticals (ETON - Free Report) and Dynavax Technologies (DVAX - Free Report) . Eton currently sports a Zacks Rank #1 (Strong Buy) and Dynavax carries a Rank #2 (Buy).
Loss estimates for Eton for 2023 have narrowed to 10 cents from 31 cents in the past 60 days, while earnings estimates for 2024 are pegged at 26 cents per share.
Loss estimates for Dynavax for 2023 have narrowed to 23 cents from 56 cents in the past 90 days, while earnings estimates for 2024 are pinned at 3 cents per share.
See More Zacks Research for These Tickers
Normally $25 each - click below to receive one report FREE:
Image: Bigstock
Pliant (PLRX) Up on Success of Mid-Stage Liver Disease Study
Shares of Pliant Therapeutics, Inc. (PLRX - Free Report) gained 14.3% on Sep 26 after the company announced that its mid-stage study on lead pipeline candidate bexotegrast was successful.
The phase IIa INTEGRIS-PSC study, a randomized, dose-ranging, double-blind, placebo-controlled trial, is evaluating bexotegrast at once-daily doses of 40 mg, 80 mg, 160 mg or placebo for 12 weeks in 85 patients with primary sclerosing cholangitis (PSC).
The study enrolled 64 patients in the active arms and 21 patients in the placebo arm.
The primary endpoint of the INTEGRIS-PSC trial is the evaluation of the safety and tolerability of bexotegrast. The secondary endpoint is an assessment of its pharmacokinetics.
PSC, a rare, progressive liver disease of unknown origin, often occurs in the setting of inflammatory bowel disease. The disease is characterized by inflammation and fibrosis, with progressive liver and biliary damage leading to cirrhosis and liver failure.
The trial met its primary and secondary endpoints, demonstrating that the candidate was well tolerated over a 12-week treatment period and that its plasma concentrations increased with dosage.
Of the 64 patients treated with bexotegrast, 60 completed 12 weeks of treatment with no deaths or drug-related severe adverse events. The treatment-emergent adverse events that came up were mild or moderate in severity and consistent with PSC disease symptoms. Patients in the trial who had concomitant inflammatory bowel disease (IBD) saw no change in their IBD symptoms as measured by the partial Mayo Score while on treatment.
The study’s exploratory efficacy endpoints assessed changes in the liver fibrosis markers, Enhanced Liver Fibrosis (ELF) score and PRO-C3 levels, as well as liver biochemistry and magnetic resonance imaging (MRI) of the liver.
Bexotegrast was effective in reducing both ELF scores and PRO-C3 levels at week 12 at all doses relative to placebo, as observed from the results of the three initial doses evaluated. Statistically significant differences were observed at the 160 mg dose relative to placebo at week 12. The enrolled patients also showed stabilization of liver chemistry, including a dose-dependent trend in the reduction of alkaline phosphatase levels relative to placebo.
Preliminary MRI imaging results suggested improved hepatocyte function and bile flow with bexotegrast 160 mg.
The study’s success and compelling results, with bexotegrast demonstrating a favorable tolerability profile and antifibrotic activity across all doses, provide hope to this patient population, which currently lacks approved therapeutic options.
Meanwhile, Pliant has recently completed enrollment of the high-dose 320 mg cohort of the INTEGRIS-PSC phase IIa trial. The company expects to report twelve-week interim data from the 320 mg dose in the first quarter of 2024 and 24-week data is expected in mid-2024.
Bexotegrast is an oral, small-molecule, dual-selective inhibitor of αvß6 and αvß1 integrins. It is also being evaluated for the treatment of idiopathic pulmonary fibrosis (IPF). Pliant has initiated a phase IIb study, BEACON-IPF, of bexotegrast in IPF.
Bexotegrast enjoys Fast Track Designation and Orphan Drug Designation in the United States in IPF and PSC. It also obtained Orphan Drug Designation from the European Medicines Agency in IPF and PSC.
The successful development and commercialization of bexotegrast will be a significant boost for the company.
Shares of Pliant have lost 13.8% in the year so far compared with the industry’s decline of 15.9%.
Image Source: Zacks Investment Research
This apart, Pliant has also developed PLN-1474, a small-molecule, selective inhibitor of αvß1 integrin for the treatment of nonalcoholic steatohepatitis with liver fibrosis. Pliant has also initiated an early-stage study for its third clinical program, PLN-101095, a small-molecule, dual-selective inhibitor of αvß8 and αvß1 integrins that is being developed for the treatment of solid tumors.
Pliant entered into an agreement with Novartis (NVS - Free Report) for the development and commercialization of PLN-1474 and up to three additional integrin research targets in 2019.
However, on Feb 17, 2023, Novartis exercised its right to terminate the agreement as part of its new strategy to focus on a limited number of therapeutic areas. The termination took effect in April and consequently, all rights and licenses granted to Novartis, including PLN-1474, the related investigational new drug and the validated research target, were returned to Pliant.
Zacks Rank & Stocks to Consider
Pliant currently carries a Zacks Rank #3 (Hold).
Some well-placed stocks in the industry are Eton Pharmaceuticals (ETON - Free Report) and Dynavax Technologies (DVAX - Free Report) . Eton currently sports a Zacks Rank #1 (Strong Buy) and Dynavax carries a Rank #2 (Buy).
You can see the complete list of today’s Zacks #1 Rank stocks here.
Loss estimates for Eton for 2023 have narrowed to 10 cents from 31 cents in the past 60 days, while earnings estimates for 2024 are pegged at 26 cents per share.
Loss estimates for Dynavax for 2023 have narrowed to 23 cents from 56 cents in the past 90 days, while earnings estimates for 2024 are pinned at 3 cents per share.