GRI Bio Inc (NASDAQ:GRI) saw its stock gain by 37.6% in premarket trading on Wednesday. The surge followed the release of new data from its Phase 2a clinical study of GRI-0621, a drug targeting Idiopathic Pulmonary Fibrosis (IPF).
The biotechnology company shared RNA-sequencing results that revealed significant improvements in genes linked to lung injury, myofibroblast activation, and fibrosis progression. These findings build on earlier reports of positive biomarker, functional, and clinical outcomes from the same study.
According to GRI Bio, the data highlights GRI-0621's ability to directly address the core biology of IPF. The study identified differentially expressed genes tied to key disease drivers. This supports a mechanism that promotes fibrosis resolution and active tissue repair.
Notably, the gene expression data suggests the drug may help regenerate lung architecture. It goes beyond merely slowing disease progression. Changes observed in treated subjects pointed to basement membrane repair and epithelial cell transition. These are critical markers of lung regeneration.
Marc Hertz, CEO of GRI Bio, expressed optimism about the results. "The data from the Phase 2a study exceed our expectations," he said. "Across gene expression, serum biomarkers, immune profiles, and lung function, we see a remarkably consistent picture. GRI-0621 appears to suppress ongoing injury, reduce fibrosis, and activate mechanisms associated with rebuilding damaged lung tissue."
The Phase 2a study had already met its primary goal, showing favorable safety and tolerability. It also achieved multiple secondary endpoints, indicating disease-modifying activity. Improvements in forced vital capacity (FVC) were particularly noteworthy. Twice as many patients treated with GRI-0621 showed no decline in FVC at 12 weeks compared to those on standard care alone.
Looking ahead, GRI Bio plans to present these new gene expression findings at a major medical conference.
