News & Events zu GRI Bio Inc (GRI)GRIGRI Bio Inc

GRI Bio Announces New Data on GRI-0621

GRI Bio announced new translational biomarker data from the Phase 2a GRI-0621-IPF-02 study evaluating GRI-0621 in patients with idiopathic pulmonary fibrosis. The new data, together with the study's lung function and safety results, were presented in a late-breaking oral presentation and three posters at the 2026 European Respiratory Society Congress in Barcelona, Spain. The data presented at ERS integrate, for the first time, four independent measurement modalities from the same 35-patient study population: whole-blood RNA sequencing, an expanded 12-marker serum extracellular matrix neo-epitope panel, 28-color spectral flow cytometry of paired blood and bronchoalveolar lavage samples, and clinical and patient-reported readouts. Across these modalities, the Phase 2a evidence resolves into nine coherent mechanistic pillars that define how selective RARbeta/gamma agonism by GRI-0621 acts in IPF: immune re-balancing, reduced lung injury, myofibroblast inhibition, fibrolysis, basement-membrane repair, re-epithelialization, FVC stabilization, antitussive effect and gastrointestinal protection. Each pillar is supported by direction-consistent signals from at least two independent modalities. Newly reported observations from whole-blood RNA sequencing of 72 curated anchor genes, 28-color spectral flow cytometry of paired blood and bronchoalveolar lavage samples and an expanded 12-marker serum ECM panel provide concordant, direction-consistent signals across the mechanistic pillars. Eighteen anchor transcripts reached statistical significance, including ALDH1A2 confirming pharmacodynamic engagement of the retinoic acid receptor pathway, and 13 flow cytometry readouts reached p less than 0.05.

GRI Bio Receives FDA Orphan Drug Designation for GRI-0621

GRI Bio announced that the U.S. Food and Drug Administration, FDA, has granted Orphan Drug Designation, ODD, to GRI-0621 for the treatment of Idiopathic Pulmonary Fibrosis, a progressive, irreversible and ultimately fatal lung disease affecting tens of thousands of patients in the United States. "Receiving FDA Orphan Drug Designation for GRI-0621 in IPF is an important validation of our development strategy and highlights the urgent need for innovative therapies capable of altering the course of this devastating disease," said Marc Hertz, Ph.D., Chief Executive Officer of GRI Bio. "We believe GRI-0621's differentiated mechanism of action has the potential to address key drivers of inflammation and fibrosis, and this designation strengthens our ability to advance the program efficiently while creating significant long-term value for patients and shareholders."