1. Study met primary endpoint, showing GRI-0621 was well tolerated after 12 weeks. 2. Significant improvements in collagen turnover biomarkers were observed with GRI-0621. 3. 39% of GRI-0621 subjects experienced an increase in forced vital capacity at 12 weeks. 4. GRI-0621 demonstrated disease-modifying potential in idiopathic pulmonary fibrosis treatment. 5. No serious adverse effects were reported, distinguishing it from existing treatments.
FAQ
Why Very Bullish?
The positive Phase 2a results indicate a strong safety and efficacy profile, similar to successful past biotech trials leading to significant stock appreciation.
How important is it?
The results indicate a significant therapeutic advance, positioning GRI Bio as a key player in the IPF market with potential for further developments.
Why Long Term?
As GRI-0621 progresses through clinical trials and potentially receives regulatory approval, its value in IPF treatment can lead to major revenue streams.
GRI Bio Announces Positive Phase 2a Study Results for GRI-0621 in Idiopathic Pulmonary Fibrosis
LA JOLLA, CA, Dec. 10, 2025 (GLOBE NEWSWIRE) – GRI Bio, Inc. (NASDAQ: GRI), a biotechnology company specializing in immune cell modulators for inflammatory and fibrotic diseases, has released positive topline data from its Phase 2a clinical trial. The study evaluated GRI-0621 for the treatment of Idiopathic Pulmonary Fibrosis (IPF) and met its primary and secondary endpoints, indicating that GRI-0621 was well tolerated by participants over a 12-week period.
Safety and Tolerability Profile of GRI-0621
The study demonstrated no severe or serious drug-related adverse events. Commonly reported side effects included dry skin, dry lips, muscle pain, and joint pain. Notably, there was a marked decrease in cough (0% in the GRI-0621 group vs. 25% in the placebo group) and gastrointestinal issues (diarrhea reported in 13% vs. 33%, respectively). Approximately 80% of participants were concurrently using background treatments such as pirfenidone or nintedanib.
Improvements in Biomarkers and Lung Function
Results from the trial suggest that GRI-0621 not only met safety benchmarks but also showed promise in improving biomarkers associated with fibrosis resolution. Key observations included:
- Decrease in PRO-C6, a biomarker for type VI collagen synthesis (-3% in GRI-0621 treated subjects).
- Increase in C6M, a biomarker for type VI collagen degradation (+6% in GRI-0621 group).
- Shift from fibrogenic to fibrolytic remodeling rate, indicating potential for fibrosis resolution in treated subjects.
- Increase in PRO-C4 (type IV collagen synthesis) (+9% in the GRI-0621 arm) and decrease in C4Ma3 (type IV collagen degradation).
These biomarkers signal the induction of a lung repair mechanism and a resolution of the alveolar basement membrane fibrosis.
Significant Improvements in Forced Vital Capacity
Enhanced lung function was evidenced by increases in Forced Vital Capacity (FVC) in the GRI-0621 treated group. Specifically:
- Placebo-adjusted increase in FVC was observed at +99 ml for subjects taking GRI-0621.
- For the subset receiving both GRI-0621 and standard care, the increase was +139 ml.
- 39% of subjects treated with GRI-0621 showed an increase in FVC after 12 weeks, compared to 80% of placebo subjects showing a decline.
Expert Insights on GRI-0621's Potential
Dr. Toby Maher, Professor of Clinical Medicine at USC Los Angeles, noted, “The GRI-0621 Phase 2a trial confirmed that the treatment is safe and well tolerated. The secondary endpoints demonstrated GRI-0621's anti-fibrotic effects compared to standard care.”
Marc Hertz, PhD, CEO of GRI Bio, stated, “These results underscore GRI-0621’s potential as a treatment option for patients with IPF, highlighting its ability to address core drivers of the disease, potentially representing a significant advancement in the treatment landscape.”
Next Steps for GRI Bio
The encouraging findings from the Phase 2a trial position GRI Bio to advance GRI-0621 into the next stages of clinical development. The company aims to evaluate its long-term efficacy and the full scope of its therapeutic potential in treating IPF and other fibrotic conditions.