- The Independent Data Monitoring Committee (“IDMC”) has recommended to continue the study as planned as there are no safety concerns demonstrated in the data reviewed
- Interim results to date demonstrate GRI-0621 to be safe and well-tolerated in the first 24 patients evaluated
- 6-week interim biomarker data (n=24) expected in July 2025 and topline data expected in Q3 2025
- Currently available treatments for IPF are limited to only two approved drugs that come with significant side-effects, limited patient compliance and no impact on survival
LA JOLLA, CA — GRI Bio, Inc. (NASDAQ: GRI) (“GRI Bio” or the “Company”), a biotechnology company advancing an innovative pipeline of Natural Killer T (NKT) cell modulators for the treatment of inflammatory, fibrotic and autoimmune diseases, today reported positive 6-week interim safety results from its ongoing Phase 2a study evaluating GRI-0621 for the treatment of IPF.
GRI-0621 is the Company’s small molecule RAR-βɣ dual agonist that inhibits the activity of human Type 1 Invariant NKT (“iNKT”) cells. 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 6-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 24 patients evaluated per protocol. There were no adverse events associated with hyperlipidemia, as assessed by LDL, HDL and triglyceride (“TG”) levels in the 24 patients assessed at the 6-week visit. There were no clinically meaningful changes in HDL, LDL or TG levels in patients receiving GRI-0621, consistent with the safety data reported after the first 12 subjects completed 2-weeks of treatment, and all subjects remained within protocol accepted 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.
Marc Hertz, PhD, Chief Executive Officer of GRI Bio commented, “We are happy to report the IDMC confirmed no safety concerns in the first 24 subjects evaluated after 6-weeks of treatment, building upon the 2-week safety data reported earlier and adding to the large safety data available for oral tazarotene. We are encouraged by the consistent safety data and early anti-fibrotic trends previously reported and remain on track to report 6-week interim biomarker data in the coming weeks followed by topline data expected in the third quarter of this year.”
The Phase 2a, randomized, double-blind, multi-center, placebo-controlled, parallel-design, 2-arm study is enrolling approximately 36 subjects with IPF. Subjects are being randomized in a 2:1 ratio for GRI-0621 4.5mg or a placebo. GRI-0621 dose of 4.5mg is being compared with a dose of placebo following once daily oral administration for 12 weeks. Concurrently, a sub-study is examining the number and activity of NKT cells in bronchoalveolar lavage (“BAL”) fluid for up to 12 eligible subjects (across various centers). The primary endpoint for the study is safety and tolerability of oral GRI-0621 as assessed by clinical labs, vital signs and adverse events after 12 weeks of treatment. Secondary endpoints are baseline changes in serum biomarkers collected at week 6 and week 12; an assessment of the pharmacokinetics (PK) of GRI-0621 at the week 12 visit of treatment (steady state); and a determination of the pharmacodynamic activity of oral GRI-0621 as measured by inhibition of iNKT cell activation in blood after 6 weeks and 12 weeks, and from BAL fluid after 12 weeks of treatment in a sub-study. Additional exploratory endpoints for the study are to assess the effect of GRI-0621 on pulmonary function at baseline and after 6 weeks and 12 weeks of treatment and flow cytometry and differential gene expression at various time points.
The Company expects to report 6-week interim biomarker data in July 2025. Topline results from the Phase 2a biomarker study are expected in the third quarter of 2025.
For more information about the Phase 2a study, please visit clinicaltrials.gov and reference identifier NCT06331624.
About GRI Bio, Inc.
GRI Bio is a clinical-stage biopharmaceutical company focused on fundamentally changing the way inflammatory, fibrotic and autoimmune diseases are treated. GRI Bio’s therapies are designed to target the activity of Natural Killer T (“NKT”) cells, which are key regulators earlier in the inflammatory cascade, to interrupt disease progression and restore the immune system to homeostasis. NKT cells are innate-like T cells that share properties of both NK and T cells and are a functional link between the innate and adaptive immune responses. Type I invariant NKT (“iNKT”) cells play a critical role in propagating the injury, inflammatory response, and fibrosis observed in inflammatory and fibrotic indications. GRI Bio’s lead program, GRI-0621, is an inhibitor of iNKT cell activity and is being developed as a novel oral therapeutic for the treatment of idiopathic pulmonary fibrosis, a serious disease with significant unmet need. The Company is also developing a pipeline of novel type 2 diverse NKT (“dNKT”) agonists for the treatment of systemic lupus erythematosus. Additionally, with a library of over 500 proprietary compounds, GRI Bio has the ability to fuel a growing pipeline.
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