GRI Bio Inc (NASDAQ:GRI) saw its shares climb sharply in premarket trading Wednesday after the company released further genetic data from its Phase 2a clinical trial of GRI-0621 for idiopathic pulmonary fibrosis (IPF).
The newly disclosed RNA-sequencing results showed statistically significant improvements across sets of genes associated with lung injury, myofibroblast activation, and progression of fibrosis when compared with placebo. According to the company, these gene-expression changes are aligned with earlier biomarker, functional, and clinical signals observed in the same study.
Findings and interpretation
GRI Bio reported that the differential gene expression indicates GRI-0621 engages core aspects of IPF biology. The company described links between the affected genes and central disease drivers, interpreting the pattern as consistent with fibrosis resolution and active tissue repair rather than solely slowing disease progression.
Specifically, the firm highlighted gene-expression shifts consistent with basement membrane repair and transitions of epithelial cells in treated participants versus placebo, which the company characterized as hallmarks of lung regeneration.
Clinical context and study endpoints
The Phase 2a trial previously met its primary endpoint, demonstrating favorable safety and tolerability. The study also achieved multiple secondary endpoints the company says are indicative of disease-modifying activity. Additionally, the trial showed improvements in forced vital capacity (FVC): twice as many subjects receiving GRI-0621 experienced no decline in FVC at 12 weeks compared with those receiving standard of care alone.
GRI Bio indicated it plans to submit the newly reported gene-expression findings for presentation at a major medical conference.
Company comment
Marc Hertz, the company's chief executive officer, commented on the data: "The data from the Phase 2a study exceed our expectations. Across gene expression, serum biomarkers, immune profiles and lung function, we see a remarkably consistent picture emerge. GRI-0621 appears to suppress ongoing injury, reduce fibrosis, and activate mechanisms associated with rebuilding damaged lung tissue."
Market reaction
The disclosure of the new RNA-sequencing results corresponded with a 37.6% increase in GRI Bio's stock in premarket trading on Wednesday.
While the company interprets the gene-expression profile as supporting regeneration of lung architecture, the reported findings stem from the Phase 2a dataset and will be included in planned scientific presentation materials.