GRI Bio shared six-week interim safety results from its Phase IIa trial of GRI-0621, a RAR-βÉŁ dual agonist for idiopathic pulmonary fibrosis (IPF). The oral 4.5mg dose was well tolerated in the first 24 patients, with no adverse effects related to hyperlipidaemia and no significant changes in LDL, HDL, or triglyceride levels. Based on these findings, the interim analysis committee recommended the trial proceed as planned.
The double-blind, placebo-controlled study aims to enroll 36 participants, randomized 2:1 to receive GRI-0621 or placebo. The primary focus is on safety and tolerability over 12 weeks, with secondary endpoints including biomarker shifts, pharmacokinetics, and iNKT cell inhibition. A sub-study will assess NKT cells in lung fluid. Six-week biomarker data is expected in July, with topline results in Q3. Findings align with past safety data from oral tazarotene trials.
01-07-2025