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LA JOLLA, CA - GRI Bio, Inc. (NASDAQ: GRI), a biotechnology firm focusing on treatments for inflammatory and autoimmune diseases, has announced interim safety results from its Phase 2a study of GRI-0621, a potential therapy for Idiopathic Pulmonary Fibrosis (IPF). The company, currently valued at $1.68 million, has seen its stock decline over 98% in the past year, though InvestingPro analysis suggests the shares may be undervalued. The Independent Data Monitoring Committee (IDMC) advised the trial to proceed without modifications, citing no safety concerns in the initial data.
The ongoing study has so far found GRI-0621 to be safe and well-tolerated in the first 12 patients, following a pre-planned interim analysis for 2-week safety results. Patients showed no significant changes in lipid levels, including LDL, HDL, and triglycerides, maintaining normal ranges. Despite operating losses, the company maintains a healthy liquidity position with a current ratio of 3.43 and more cash than debt on its balance sheet.
GRI-0621, an oral small molecule RAR-β/γ dual agonist, has demonstrated efficacy in improving fibrosis in multiple disease models and in improving liver function tests and other markers of inflammation and injury in patients. The drug’s receptor selectivity aligns with the toxicity profile observed in earlier studies with oral tazarotene, which included over 1,700 patients treated for up to a year.
Marc Hertz, PhD, CEO of GRI Bio, expressed optimism about the preliminary safety data, highlighting the potential of GRI-0621 to offer a safer and more effective treatment option for IPF, a condition with significant unmet medical needs. Current IPF treatments can slow lung function decline but are not curative and have significant side effects that limit their use.
The Phase 2a study is a randomized, double-blind, multi-center, placebo-controlled trial, which aims to enroll approximately 36 subjects. The primary endpoint is the safety and tolerability of oral GRI-0621 after 12 weeks of treatment, with secondary endpoints including changes in serum biomarkers and assessments of the drug’s pharmacokinetics and pharmacodynamics.
GRI Bio expects to release interim biomarker data in Q2 2025, with topline results anticipated in Q3 2025. The company’s next earnings report is scheduled for May 15, 2025. InvestingPro subscribers have access to 13 additional investment tips and comprehensive financial analysis for GRI Bio, including detailed Fair Value estimates and financial health scores. This press release statement serves as the basis for the reported facts.
In other recent news, GRI Bio has secured two significant global patents, enhancing its intellectual property portfolio. These patents cover novel activators and methods for modulating Natural Killer T (NKT) cells, which are crucial in treating autoimmune and inflammatory diseases. In addition to this development, GRI Bio has regained compliance with the Nasdaq minimum bid price requirement, marking a positive step in maintaining its stock listing. The company has also received stockholder approval for a reverse stock split, which aims to increase the per-share trading price of its common stock. This move could potentially attract broader market interest and ensure better compliance with Nasdaq’s listing standards. GRI Bio continues to advance its lead program, GRI-0621, through a Phase 2a study for idiopathic pulmonary fibrosis, with interim results expected in 2025. The company’s focus remains on developing therapies targeting NKT cells to address significant unmet medical needs.
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