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GRI Bio Announces Positive Topline Data from Phase 2a Study in Idiopathic Pulmonary Fibrosis

GRI Bio, Inc. (GRI) | December 10, 2025

By Bob Smith

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GRI Bio announced positive topline data from the Phase 2a clinical trial of GRI-0621 for treating Idiopathic Pulmonary Fibrosis (IPF).

The study demonstrated that GRI-0621 was well tolerated over a 12-week treatment period with positive outcomes on biomarkers and forced vital capacity (FVC).

Key findings included safety, tolerability, and improvements in biomarkers suggesting fibrosis resolution and repair of the alveolar basement membrane.

Positive Topline Data

The study met its primary and secondary endpoints, showing safety, tolerability, and improvements in biomarkers and FVC compared to standard of care.

Safety Profile

No severe adverse events related to GRI-0621 were reported, with tolerability comparable to existing treatments for IPF.

Biomarker Improvements

GRI-0621 demonstrated positive effects on biomarkers of collagen turnover, indicating fibrosis resolution and lung tissue repair.

  • The study results suggest that GRI-0621 could offer a safe and effective treatment option for patients with IPF, potentially providing disease-modifying benefits.
  • Improvements in biomarkers and lung function indicators could signify a positive shift towards addressing the underlying mechanisms of IPF.
  • The observed improvements in FVC and collagen turnover biomarkers may indicate a potential therapeutic pathway for combating fibrosis progression in IPF patients.

The positive topline data from the Phase 2a study of GRI-0621 in IPF highlights its potential as a promising treatment option. Further clinical advancements in this direction could lead to significant benefits for IPF patients in the future.