{"id":832414,"date":"2025-04-01T12:43:21","date_gmt":"2025-04-01T16:43:21","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/gri-bio-reports-encouraging-interim-2-week-safety-results-from-ongoing-phase-2a-study-of-gri-0621-in-idiopathic-pulmonary-fibrosis-ipf\/"},"modified":"2025-04-01T12:43:21","modified_gmt":"2025-04-01T16:43:21","slug":"gri-bio-reports-encouraging-interim-2-week-safety-results-from-ongoing-phase-2a-study-of-gri-0621-in-idiopathic-pulmonary-fibrosis-ipf","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/gri-bio-reports-encouraging-interim-2-week-safety-results-from-ongoing-phase-2a-study-of-gri-0621-in-idiopathic-pulmonary-fibrosis-ipf\/","title":{"rendered":"GRI Bio Reports Encouraging Interim 2-Week Safety Results from Ongoing Phase 2a Study of GRI-0621 in Idiopathic Pulmonary Fibrosis (\u201cIPF\u201d)"},"content":{"rendered":"
\n

\n The Independent Data Monitoring Committee (IDMC) has recommended to continue study as planned as there are no safety concerns seen in the data reviewed<\/em>\n <\/p>\n

\n Interim results demonstrate GRI-0621 to be safe and well-tolerated in the first 12 patients evaluated <\/em>\n <\/p>\n

\n Interim biomarker data on track for Q2 2025 and topline results expected Q3 2025<\/em>\n <\/p>\n

\n 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<\/em>\n <\/p>\n

\n LA JOLLA, CA, April 01, 2025 (GLOBE NEWSWIRE) — <\/strong>
\n
\n GRI Bio, Inc.<\/u>
\n <\/a> (NASDAQ: GRI) (\u201cGRI Bio\u201d or the \u201cCompany\u201d), a biotechnology company advancing an innovative pipeline of Natural Killer T (\u201cNKT\u201d) cell modulators for the treatment of inflammatory, fibrotic and autoimmune diseases, today reported interim safety results from its ongoing Phase 2a study evaluating GRI-0621 for the treatment of Idiopathic Pulmonary Fibrosis (\u201cIPF\u201d).<\/p>\n

GRI-0621, is the Company\u2019s small molecule RAR-\u03b2\u0263 dual agonist that inhibits the activity of human Type 1 Invariant NKT (\u201ciNKT\u201d) 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.<\/p>\n

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\u2019s 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.<\/p>\n

Marc Hertz, PhD, Chief Executive Officer of GRI Bio commented, \u201cWhile preliminary, in the first 12 subjects evaluated these results are encouraging and in line with our expectations. We believe these results, particularly the safety data, underscore GRI-0621\u2019s potential to provide a much needed safe and effective treatment option for the treatment of IPF, where there remains significant unmet need. The two ant-fibrotic drugs currently approved for the treatment of IPF can slow the decline of lung function but are not curative, do not improve overall survival, and both come with significant side effects which limit their use. Based on the trends seen in these interim results, as well as the consistent toxicity profile with tazarotene, we believe GRI-0621 will continue to demonstrate that the molecule is safe and inhibits NKT cell activity in this patient population, providing much needed benefit to patients. Our team remains focused on driving enrollment and treatment in the study and we look forward to reporting topline data in the third quarter of 2025.\u201d<\/p>\n

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 (\u201cBAL\u201d) 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.<\/p>\n

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.<\/p>\n

For more information about the Phase 2a study, please visit clinicaltrials.gov<\/u><\/a> and reference identifier NCT06331624.<\/p>\n

\n About GRI Bio, Inc.<\/strong>\n <\/p>\n

GRI Bio is a clinical-stage biopharmaceutical company focused on fundamentally changing the way inflammatory, fibrotic and autoimmune diseases are treated. GRI Bio\u2019s therapies are designed to target the activity of Natural Killer T (\u201cNKT\u201d) 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 (\u201ciNKT\u201d) cells play a critical role in propagating the injury, inflammatory response, and fibrosis observed in inflammatory and fibrotic indications. GRI Bio\u2019s 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 (\u201cdNKT\u201d) 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.<\/p>\n

\n Forward-Looking Statements<\/strong>\n <\/p>\n

This press release contains \u201cforward-looking statements\u201d within the meaning of the \u201csafe harbor\u201d provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words such as \u201canticipate,\u201d \u201cbelieve,\u201d \u201ccontemplate,\u201d \u201ccould,\u201d \u201cestimate,\u201d \u201cexpect,\u201d \u201cintend,\u201d \u201cseek,\u201d \u201cmay,\u201d \u201cmight,\u201d \u201cplan,\u201d \u201cpotential,\u201d \u201cpredict,\u201d \u201cproject,\u201d \u201ctarget,\u201d \u201caim,\u201d \u201cshould,\u201d \u201cwill,\u201d \u201cwould,\u201d or the negative of these words or other similar expressions. These forward-looking statements are based on the Company\u2019s current beliefs and expectations. Forward-looking statements include, but are not limited to, statements regarding: the Company\u2019s expectations with respect to development and commercialization of the Company\u2019s product candidates, the timing of initiation or completion of clinical trials and availability of resulting data, the potential benefits and impact of the Company\u2019s 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\u2019s beliefs and expectations regarding potential shareholder value and future financial performance, the Company\u2019s beliefs and estimates about its cash and available resources and its ability to fund its planned operations through any particular date, the Company\u2019s beliefs about the timing and outcome of regulatory approvals and potential regulatory approval pathways, the Company\u2019s expected milestones in 2025, and the Company\u2019s 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\u2019s 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\u2019s 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\u2019s 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\u2019s estimates regarding expenses, future revenue, capital requirements and needs for and the ability to obtain additional financing; (11) the Company\u2019s 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\u2019s filings with the U.S. Securities and Exchange Commission (the \u201cSEC\u201d), including the risks and uncertainties described in the \u201cRisk Factors\u201d section of the Company\u2019s 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.<\/p>\n

\n Investor Contact:<\/strong>
\n
JTC Team, LLC
Jenene Thomas
(908) 824-0775
GRI@jtcir.com<\/u><\/a><\/p>\n

\"\"
\n
\n \"\"\n <\/div>\n

<\/div>\n","protected":false},"excerpt":{"rendered":"

The Independent Data Monitoring Committee (IDMC) has recommended to continue study as planned as there are no safety concerns seen in the data reviewed Interim results demonstrate GRI-0621 to be safe and well-tolerated in the first 12 patients evaluated Interim biomarker data on track for Q2 2025 and topline results expected 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, April 01, 2025 (GLOBE NEWSWIRE) — GRI Bio, Inc. (NASDAQ: GRI) (\u201cGRI Bio\u201d or the \u201cCompany\u201d), a biotechnology company advancing an innovative pipeline of Natural Killer T (\u201cNKT\u201d) cell modulators for the treatment of inflammatory, fibrotic and autoimmune diseases, … <\/p>\n

Continue reading “GRI Bio Reports Encouraging Interim 2-Week Safety Results from Ongoing Phase 2a Study of GRI-0621 in Idiopathic Pulmonary Fibrosis (\u201cIPF\u201d)”<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-832414","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"\nGRI Bio Reports Encouraging Interim 2-Week Safety Results from Ongoing Phase 2a Study of GRI-0621 in Idiopathic Pulmonary Fibrosis (\u201cIPF\u201d) - Market Newsdesk<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.marketnewsdesk.com\/index.php\/gri-bio-reports-encouraging-interim-2-week-safety-results-from-ongoing-phase-2a-study-of-gri-0621-in-idiopathic-pulmonary-fibrosis-ipf\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"GRI Bio Reports Encouraging Interim 2-Week Safety Results from Ongoing Phase 2a Study of GRI-0621 in Idiopathic Pulmonary Fibrosis (\u201cIPF\u201d) - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"The Independent Data Monitoring Committee (IDMC) has recommended to continue study as planned as there are no safety concerns seen in the data reviewed Interim results demonstrate GRI-0621 to be safe and well-tolerated in the first 12 patients evaluated Interim biomarker data on track for Q2 2025 and topline results expected 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, April 01, 2025 (GLOBE NEWSWIRE) — GRI Bio, Inc. (NASDAQ: GRI) (\u201cGRI Bio\u201d or the \u201cCompany\u201d), a biotechnology company advancing an innovative pipeline of Natural Killer T (\u201cNKT\u201d) cell modulators for the treatment of inflammatory, fibrotic and autoimmune diseases, … Continue reading "GRI Bio Reports Encouraging Interim 2-Week Safety Results from Ongoing Phase 2a Study of GRI-0621 in Idiopathic Pulmonary Fibrosis (\u201cIPF\u201d)"\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.marketnewsdesk.com\/index.php\/gri-bio-reports-encouraging-interim-2-week-safety-results-from-ongoing-phase-2a-study-of-gri-0621-in-idiopathic-pulmonary-fibrosis-ipf\/\" \/>\n<meta property=\"og:site_name\" content=\"Market Newsdesk\" \/>\n<meta property=\"article:published_time\" content=\"2025-04-01T16:43:21+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=OTQxNDc2OCM2ODQ1MTQ0IzUwMDA3NTQ4OA==\" \/>\n<meta name=\"author\" content=\"Newsdesk\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Newsdesk\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"8 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/gri-bio-reports-encouraging-interim-2-week-safety-results-from-ongoing-phase-2a-study-of-gri-0621-in-idiopathic-pulmonary-fibrosis-ipf\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/gri-bio-reports-encouraging-interim-2-week-safety-results-from-ongoing-phase-2a-study-of-gri-0621-in-idiopathic-pulmonary-fibrosis-ipf\\\/\"},\"author\":{\"name\":\"Newsdesk\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/#\\\/schema\\\/person\\\/482f27a394d4fda80ecb5499e519d979\"},\"headline\":\"GRI Bio Reports Encouraging Interim 2-Week Safety Results from Ongoing Phase 2a Study of GRI-0621 in Idiopathic Pulmonary Fibrosis (\u201cIPF\u201d)\",\"datePublished\":\"2025-04-01T16:43:21+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/gri-bio-reports-encouraging-interim-2-week-safety-results-from-ongoing-phase-2a-study-of-gri-0621-in-idiopathic-pulmonary-fibrosis-ipf\\\/\"},\"wordCount\":1605,\"image\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/gri-bio-reports-encouraging-interim-2-week-safety-results-from-ongoing-phase-2a-study-of-gri-0621-in-idiopathic-pulmonary-fibrosis-ipf\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/www.globenewswire.com\\\/newsroom\\\/ti?nf=OTQxNDc2OCM2ODQ1MTQ0IzUwMDA3NTQ4OA==\",\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/gri-bio-reports-encouraging-interim-2-week-safety-results-from-ongoing-phase-2a-study-of-gri-0621-in-idiopathic-pulmonary-fibrosis-ipf\\\/\",\"url\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/gri-bio-reports-encouraging-interim-2-week-safety-results-from-ongoing-phase-2a-study-of-gri-0621-in-idiopathic-pulmonary-fibrosis-ipf\\\/\",\"name\":\"GRI Bio Reports Encouraging Interim 2-Week Safety Results from Ongoing Phase 2a Study of GRI-0621 in Idiopathic Pulmonary Fibrosis (\u201cIPF\u201d) - 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