GRI Bio Continues to Drive Enrollment in Ongoing Phase 2a Study of GRI-0621 in Idiopathic Pulmonary Fibrosis (“IPF”)
- Successful completion of 6-week interim analysis enrollment with 24/36 patients
- Initial 2-week safety results showed GRI-0621 to be safe and well-tolerated
- No hyperlipidemia observed in the first 12 patients
- Study progressing on schedule with interim and topline results expected in Q2 and Q3 2025
- None.
Insights
GRI Bio's Phase 2a trial in IPF progressing on schedule with good safety profile; upcoming biomarker data will provide first efficacy signals.
GRI Bio has achieved a significant enrollment milestone in their Phase 2a study of GRI-0621 for Idiopathic Pulmonary Fibrosis (IPF), with 24 of 36 planned patients now randomized. This completes enrollment for the planned 6-week interim analysis, keeping the company on track for reporting interim biomarker data this quarter and topline results in Q3 2025.
The preliminary 2-week safety results from the first 12 patients show that GRI-0621 at 4.5mg daily is well-tolerated with no evidence of hyperlipidemia—a notable observation since lipid abnormalities can be problematic with certain immunomodulatory agents. All subjects maintained normal HDL, LDL, and triglyceride levels, suggesting a clean initial safety profile consistent with tazarotene's receptor selectivity profile.
The study design employs robust methodology: randomized, double-blind, placebo-controlled with 2:1 randomization favoring treatment. The primary endpoint appropriately focuses on safety over 12 weeks, while secondary endpoints include biomarkers, pharmacokinetics, and pharmacodynamic effects on Natural Killer T (NKT) cell inhibition—the therapeutic mechanism targeted by GRI-0621.
Particularly valuable is the bronchoalveolar lavage (BAL) sub-study in up to 12 patients, which directly examines NKT cell activity in lung tissue. This provides critical target engagement data in the organ most affected by IPF's progressive fibrosis. The upcoming biomarker results will offer the first meaningful signals of potential efficacy.
IPF represents a serious unmet medical need characterized by progressive lung scarring and limited effective therapies. While this enrollment update confirms the development program remains on schedule, the biomarker data expected imminently will provide more substantive insights into GRI-0621's potential as a treatment option.
Enrollment completed for the 6-week interim analysis with 24 of the 36 planned patients now enrolled
Company on track to report interim biomarker data from the first 12 patients imminently
Completion of patient enrollment and topline results expected Q3 2025
LA JOLLA, CA, May 07, 2025 (GLOBE NEWSWIRE) -- 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 announced that enrollment for the 6 week interim analysis is complete with 24 of the 36 planned patients randomized in its ongoing Phase 2a study evaluating GRI-0621 for the treatment of Idiopathic Pulmonary Fibrosis (“IPF”).
“We are pleased with the progress made in this Phase 2a biomarker study. With the patient participation seen in the trial to date, we remain on track to report interim data later this quarter and topline results from this important study in the third quarter of this year,” commented Marc Hertz, PhD, Chief Executive Officer of GRI Bio. “The momentum with enrollment combined with our recently announced interim safety results, bolsters our confidence in the potential of GRI-0621 to provide a much needed treatment option for the treatment of IPF, where there remains significant unmet need. We are grateful for the dedicated work and participation of our clinical staff, patients and families in this trial. Our team is working to bring enrollment to its completion, expected this quarter and report topline data in the third quarter of 2025.”
The Phase 2a, randomized, double-blind, multi-center, placebo-controlled, parallel-design, 2-arm study will enroll approximately 36 subjects with IPF whom will be randomized in a 2:1 ratio for GRI-0621 4.5mg or a placebo. GRI-0621 dose of 4.5mg will be compared with a dose of placebo following once daily oral administration for 12 weeks. Concurrently, a sub-study will examine the number and activity of NKT cells in bronchoalveolar lavage (“BAL”) fluid for up to 12 eligible subjects (across various centers). An interim analysis will be performed when 24 subjects (of which approximately 8 will be placebo subjects) complete 6 weeks of treatment. 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.
As previously announced, 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, as assessed by LDL, HDL and triglyceride (TG) levels, was not seen in the 12 patients assessed at the 2-week visit. There were no meaningful changes in HDL, LDL or TG 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 from the first 12 patients enrolled in Q2 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.
Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “target,” “aim,” “should,” “will,” “would,” or the negative of these words or other similar expressions. These forward-looking statements are based on the Company’s current beliefs and expectations. Forward-looking statements include, but are not limited to, statements regarding: the Company’s expectations with respect to development and commercialization of the Company’s product candidates, the timing of initiation or completion of clinical trials and availability of resulting data, the potential benefits and impact of the Company’s clinical trials and product candidates and any implication that the data or results observed in preclinical trials or earlier studies or trials will be indicative of results of later studies or clinical trials, the Company’s beliefs and expectations regarding potential shareholder value and future financial performance, the Company’s beliefs and estimates about its cash and available resources and its ability to fund its planned operations through any particular date, the Company’s beliefs about the timing and outcome of regulatory approvals and potential regulatory approval pathways, the Company’s expected milestones in 2025, and the Company’s beliefs and expectations regarding the sufficiency of its existing cash and cash equivalents to fund its planned operations, its ability to raise additional funds, which may not be available to the Company on acceptable terms, or at all, and capital expenditure requirements. Actual results may differ from the forward-looking statements expressed by the Company in this press release and consequently, you should not rely on these forward-looking statements as predictions of future events. These forward-looking statements are subject to inherent uncertainties, risks and assumptions that are difficult to predict, including, without limitation: (1) the inability to maintain the listing of the Company’s common stock on The Nasdaq Capital Market and to comply with applicable listing requirements; (2) changes in applicable laws or regulations; (3) the inability of the Company to raise financing in the future; (4) the success, cost and timing of the Company’s product development activities; (5) the inability of the Company to obtain and maintain regulatory clearance or approval for its respective products, and any related restrictions and limitations of any cleared or approved product; (6) the inability of the Company to identify, in-license or acquire additional technology; (7) the inability of the Company to compete with other companies currently marketing or engaged in the development of products and services that the Company is currently developing; (8) the size and growth potential of the markets for the Company’s products and services, and their respective ability to serve those markets, either alone or in partnership with others; (9) the failure to achieve any milestones or receive any milestone payments under any agreements; (10) inaccuracy in the Company’s estimates regarding expenses, future revenue, capital requirements and needs for and the ability to obtain additional financing; (11) the Company’s ability to protect and enforce its intellectual property portfolio, including any newly issued patents; and (12) other risks and uncertainties indicated from time to time in the Company’s filings with the U.S. Securities and Exchange Commission (the “SEC”), including the risks and uncertainties described in the “Risk Factors” section of the Company’s most recent Annual Report on Form 10-K filed with the SEC on March 14, 2025 and subsequently filed reports. In particular, the data discussed in this release is interim data and additional study and additional favorable results will be needed for development of GRI-0621 to continue; this interim data may not be indicative of later or final data for this trial. Forward-looking statements contained in this announcement are made as of this date, and the Company undertakes no duty to update such information except as required under applicable law.
Investor Contact:
JTC Team, LLC
Jenene Thomas
(908) 824-0775
GRI@jtcir.com
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