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LA JOLLA, CA - GRI Bio, Inc. (NASDAQ:GRI) announced Thursday that its Phase 2a study of GRI-0621 for idiopathic pulmonary fibrosis (IPF) treatment has yielded positive 6-week interim safety results, with the Independent Data Monitoring Committee recommending continuation of the trial. The clinical-stage biotech company, with a market capitalization of $3.2 million, maintains a strong balance sheet with more cash than debt, according to InvestingPro data.
The interim analysis showed GRI-0621, a small molecule RAR-βδ dual agonist that inhibits Type 1 Invariant NKT cell activity, was safe and well-tolerated in the first 24 patients evaluated. No adverse events related to hyperlipidemia were observed, with no clinically meaningful changes in HDL, LDL, or triglyceride levels.
"We are encouraged by the consistent safety data and early anti-fibrotic trends previously reported," said Marc Hertz, CEO of GRI Bio, according to the company’s press release.
The ongoing Phase 2a study is a randomized, double-blind, multi-center trial enrolling approximately 36 IPF patients, who receive either 4.5mg of GRI-0621 or placebo once daily for 12 weeks in a 2:1 ratio. The primary endpoint is safety and tolerability after 12 weeks of treatment.
Secondary endpoints include changes in serum biomarkers, pharmacokinetics assessment, and determination of pharmacodynamic activity through inhibition of iNKT cell activation in blood and bronchoalveolar lavage fluid.
The company expects to report 6-week interim biomarker data in July 2025, with topline results anticipated in the third quarter of 2025. While the stock has faced significant pressure, falling over 90% year-to-date, analysts maintain optimistic price targets ranging from $10 to $34. InvestingPro analysis suggests the stock may be undervalued at current levels, with 11 additional ProTips available to subscribers covering crucial financial metrics and market trends.
IPF is a serious lung disease with limited treatment options. Currently, only two approved drugs are available, which the company notes come with significant side effects, limited patient compliance, and no impact on survival.
The information in this article is based on a press release statement from GRI Bio. For comprehensive analysis of biotech stocks like GRI, including detailed financial health scores, Fair Value calculations, and peer comparisons, visit InvestingPro.
In other recent news, GRI Bio, Inc. has provided updates on its ongoing clinical trials and financial activities. The company has announced positive interim results from its Phase 2a study of GRI-0621, a treatment for Idiopathic Pulmonary Fibrosis (IPF). The Independent Data Monitoring Committee has reviewed the data and recommended the continuation of the study, citing no safety concerns and potential anti-fibrotic effects. The study is fully enrolled for its 6-week interim analysis, with results expected in the second quarter of 2025, and topline data anticipated in the third quarter of 2025.
Additionally, GRI Bio has expanded its at-the-market offering capacity, allowing for the issuance of up to $1,758,934 of common stock under an agreement with H.C. Wainwright & Co. This move is part of the company’s strategy to manage its capital effectively. Financially, GRI Bio reported a net loss of $3.0 million for the first quarter of 2025, with research and development expenses totaling $1.6 million. Following a $5.0 million public offering, the company expects its cash reserves to support operations through the third quarter of 2025.
H.C. Wainwright analysts have reiterated a Buy rating on GRI Bio’s stock, emphasizing the importance of biomarker data from the Phase 2a trial. These developments highlight GRI Bio’s continued efforts to advance its therapeutic pipeline and address unmet medical needs in the treatment of fibrotic diseases.
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