GRI Bio begins patent enrollment for Phase 2a study of GRI-0621 for IPF treatment

GRI Bio CEO Marc Hertz joined Steve Darling from Proactive to share news the company has begun patient enrollment in a Phase 2a biomarker study focused on evaluating GRI-0621 as a potential treatment for idiopathic pulmonary fibrosis (IPF). Patient dosing is expected to commence shortly, marking a significant milestone in the clinical development of the drug candidate.

The Phase 2a study is designed as a randomized, double-blind, multi-center, placebo-controlled trial involving approximately 36 subjects diagnosed with IPF. These subjects will be randomly assigned to receive either GRI-0621 at a dose of 4.5mg or a placebo in a 2:1 ratio.

The primary objective of this study is to assess the safety and tolerability of oral GRI-0621, which will be closely monitored throughout the trial. Secondary endpoints include evaluating changes in serum biomarkers collected at weeks 6 and 12.

An interim analysis of the trial is planned when 24 subjects have completed 6 weeks of treatment, with the expectation of providing preliminary insights into the drug's safety and efficacy profile.

The topline results from the Phase 2a biomarker study are anticipated to be available in the second half of 2024, shedding light on the drug's potential as a treatment option for IPF.

In addition to these primary and secondary endpoints, the study will also explore the effect of GRI-0621 on pulmonary function at baseline, as well as after 6 weeks and 12 weeks of treatment.

The trial aims to provide valuable data to advance our understanding of GRI-0621's therapeutic potential in addressing IPF, a challenging and debilitating respiratory condition.

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