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LA JOLLA - GRI Bio, Inc. (NASDAQ:GRI), a micro-cap biotech company with a market capitalization of $5.12 million, announced Thursday that interim 6-week biomarker results from its Phase 2a study of GRI-0621 for idiopathic pulmonary fibrosis (IPF) showed positive trends in fibrosis markers. According to InvestingPro data, the company maintains a favorable cash position, holding more cash than debt on its balance sheet.
The data from the first 24 subjects demonstrated that GRI-0621-treated patients exhibited reductions in fibrogenesis biomarkers and favorable fibrolytic profiles compared to the control arm. The Independent Data Monitoring Committee recommended continuing the study as planned, noting no safety concerns in the data reviewed. While the clinical results appear promising, InvestingPro analysis indicates that analysts don’t expect profitability this year, with two analysts recently revising their earnings expectations downward.
"These 6-week interim biomarker data, while early and based on a small subset of participants, continue to be encouraging," said Marc Hertz, CEO of GRI Bio, according to the company’s press release.
The Phase 2a randomized, double-blind study has fully enrolled approximately 35 subjects with IPF who were randomized in a 2:1 ratio to receive either GRI-0621 4.5mg or placebo once daily for 12 weeks.
Primary endpoints focus on safety and tolerability, while secondary endpoints include changes in serum biomarkers, pharmacokinetics, and pharmacodynamic activity. The study also includes exploratory endpoints assessing effects on pulmonary function.
Previous interim analyses at 2 weeks and 6 weeks showed GRI-0621 to be safe and well-tolerated. The company expects to report topline results from the study in the third quarter of 2025, with additional pulmonary function test data anticipated in the coming weeks.
GRI-0621 is an inhibitor of invariant Natural Killer T (iNKT) cell activity being developed for IPF, a condition with limited treatment options. Currently, only two approved drugs are available for IPF, which according to the company come with significant side effects and limited patient compliance. With the next earnings report due on August 14, investors can access comprehensive financial analysis and additional ProTips through InvestingPro’s extensive metrics and expert insights.
In other recent news, GRI Bio, Inc. announced the completion of patient enrollment for its Phase 2a clinical trial evaluating GRI-0621 in patients with idiopathic pulmonary fibrosis. The trial, which includes 36 participants, aims to assess the safety and tolerability of the drug over a 12-week period. Interim safety results from this study have been positive, with the Independent Data Monitoring Committee recommending the continuation of the trial. The drug, GRI-0621, has shown no adverse effects related to hyperlipidemia in the first 24 patients evaluated. H.C. Wainwright has reiterated its Buy rating for GRI Bio, maintaining a $10.00 price target, noting the company’s progress in its ongoing trial. Furthermore, GRI Bio has expanded its at-the-market offering capacity, allowing for the issuance of up to $1,758,934 of its common stock. This adjustment is part of an agreement with H.C. Wainwright & Co., LLC. Additionally, GRI Bio presented promising preclinical data for GRI-0621, highlighting its potential anti-inflammatory and anti-fibrotic effects in pulmonary fibrosis. These findings were shared at the American Thoracic Society International Conference.
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