GRI Bio ( GRI ), Inc. stock is trading on Tuesday with a strong session volume of 6.9 million compared to an average volume of 17.35K, as per data from Benzinga Pro.

GRI Bio ( GRI ) reported interim safety results from its ongoing Phase 2a study evaluating GRI-0621 for Idiopathic Pulmonary Fibrosis (IPF).

In preliminary clinical trials to date and previous clinical trials with the oral formulation, GRI-0621 has been shown to improve fibrosis in multiple disease models and improve liver function tests and other markers of inflammation and injury in patients.

The pre-planned interim analysis for 2-week safety results from the ongoing Phase 2a biomarker study demonstrated GRI-0621 (4.5mg orally once daily) to be safe and well-tolerated in the first 12 patients evaluated per protocol.

Hyperlipidemia (high cholesterol) was not seen in the 12 patients assessed at the 2-week visit.

There were no meaningful changes in cholesterol levels in patients receiving GRI-0621, and all subjects remained within normal ranges.

The interim analysis committee recommended the study should continue as planned.

The interim results show that GRI-0621’s receptor selectivity is consistent with the toxicity profile observed in earlier studies evaluating oral tazarotene in over 1,700 patients treated for up to 52 weeks.

The company expects to report interim biomarker data in Q2 2025. Topline results from the Phase 2a biomarker study are expected in the third quarter of 2025.

Price Action: GRI stock is up 95.9% at $6.27 at the last check Tuesday.

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