GRI Bio, Inc. (NASDAQ:GRI) on Wednesday shared topline data from the Phase 2a GRI-0621-IPF-02 trial evaluating GRI-0621 for idiopathic pulmonary fibrosis.
IPF is a chronic, progressive lung disease where lung tissue thickens and scars for unknown reasons, making it hard to breathe.
The study met its primary endpoint and secondary endpoints demonstrating that GRI-0621 was well tolerated over a 12-week treatment period, consistent with earlier studies evaluating over 1,700 subjects treated for up to a year.
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Safety Profile And Adverse Events
No safety or tolerability concerns were observed in the subjects enrolled at 12 weeks of treatment, with dry skin, dry lips, muscle and joint pain as the most common adverse events reported.
There were no increases in cough (0% in the GRI-0621-treated arm compared to 25% in the placebo arm) or gastrointestinal disorders reported in the GRI-0621 arm compared to the placebo arm (diarrhea reported in 13% versus 33%, respectively).
80% of the subjects enrolled were taking background pirfenidone or nintedanib.
Biomarker Improvements Suggest Fibrosis Resolution
Subjects treated with GRI-0621 also displayed improvements in serum biomarkers of collagen turnover, suggesting fibrosis resolution and induction of an alveolar basement membrane repair mechanism.
The type VI collagen remodeling rate shifted from fibrogenic (+10%; continued worsening of fibrosis) in placebo-treated subjects to fibrolytic (-7%; resolution of fibrosis), suggestive of GRI-0621 inducing resolution of fibrosis in treated subjects compared to continued worsening of fibrosis in subjects treated with placebo and standard of care.
GRI-0621 was observed to significantly reduce DLK1, a gene involved in lung epithelial AT2 cell fate plasticity and regeneration of alveolar AT1 cells, another critical step in alveolar basement membrane repair, compared to subjects treated with placebo and standard.
Reductions In Inflammatory And Fibrotic Pathways
Reductions in neutrophil and macrophage activity (immune cell biomarkers upregulated in IPF and associated with disease progression) and downregulation of genes associated with fibrosis, disease progression, and mortality were also observed in patients treated with GRI-0621 compared to placebo-treated subjects.
Placebo-adjusted changes from baseline in forced vital capacity (FVC) increased by 99 ml in the GRI-0621-treated arm and a 139 ml in the subset taking both GRI-0621 and standard of care, compared to placebo plus standard of care.
FVC measures lung function. Overall, 39% of GRI-0621-treated subjects experienced an increase in FVC at 12 weeks compared to 80% of subjects who experienced a decline in FVC at 12 weeks in the placebo-treated arm.
GRI Price Action: GRI Bio shares were down 7.45% at $1.11 during premarket trading on Wednesday. The stock is trading near its 52-week low of $1.10, according to Benzinga Pro data.
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