GRI Bio Inc. (GRI) has announced positive topline data from its Phase 2a study evaluating GRI-0621 in patients with Idiopathic Pulmonary Fibrosis.
Idiopathic Pulmonary Fibrosis (IPF) is a progressive, life-threatening lung disease characterized by scarring of lung tissue and limited treatment options. Current therapies slow disease progression but rarely reverse fibrosis or repair lung damage.
GRI-0621 is a small molecule RAR-ß? dual agonist designed to inhibit immune cell activity and promote lung repair.
The Phase 2a GRI-0621-IPF-02 study was a randomized, double-blind, placebo-controlled trial enrolling 35 patients over 12 weeks. Participants received either oral GRI-0621 4.5 mg once daily or placebo.
The study met its primary endpoint, demonstrating that GRI-0621 was safe and well-tolerated, with no drug-related severe adverse events. Common side effects such as mild dry skin and musculoskeletal pain were manageable, and importantly, patients receiving GRI-0621 experienced fewer cough and gastrointestinal issues compared to those on placebo.
The trial also met its secondary endpoints, showing meaningful improvements in biomarkers of collagen turnover. These findings suggest that GRI-0621 not only halted fibrosis progression but also actively promoted the resolution of scarring and repair of the alveolar basement membrane. Biomarker shifts indicated a reversal from fibrogenic activity in placebo patients to fibrolytic activity in those treated with GRI-0621, while markers of basement membrane repair also improved.
Exploratory analyses further supported the drug's potential, with nearly 40% of treated patients experiencing an increase in forced vital capacity (FVC) at 12 weeks, compared to 80% of placebo patients who saw a decline. Placebo-adjusted gains in lung function ranged from 54 ml to 139 ml, depending on subgroup analysis, underscoring the clinical relevance of the biomarker findings.
With these results, GRI Bio is positioned to advance GRI-0621 into the next stage of development, aiming to establish it as a first-in-class oral therapy capable of modifying the course of IPF. The company continues to expand its pipeline, including diverse NKT agonists for autoimmune diseases such as systemic lupus erythematosus.
GRI has traded in the range of $1.10 to $16.66 over the past year. The stock closed yesterday at $1.21, down 12.95%, and fell further to $1.16 in overnight trading, down 4.13%.
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