GRI Bio Reports Encouraging Interim 2-Week Safety Results from Ongoing Phase 2a Study of GRI-0621 in Idiopathic Pulmonary Fibrosis (“IPF”)
GRI Bio (NASDAQ: GRI) has reported encouraging interim safety results from its ongoing Phase 2a study of GRI-0621 for Idiopathic Pulmonary Fibrosis (IPF) treatment. The Independent Data Monitoring Committee recommended continuing the study as planned, with no safety concerns identified in the first 12 patients evaluated.
The study evaluates GRI-0621, a RAR-βɣ dual agonist administered at 4.5mg orally once daily. Initial results show the drug is safe and well-tolerated, with no hyperlipidemia observed in the assessed patients. The Phase 2a trial will enroll approximately 36 subjects in a 2:1 ratio (GRI-0621 vs. placebo) for a 12-week treatment period.
The study's primary endpoint focuses on safety and tolerability, with secondary endpoints including changes in serum biomarkers and pharmacodynamic activity. Interim biomarker data is expected in Q2 2025, with topline results anticipated in Q3 2025.
GRI Bio (NASDAQ: GRI) ha riportato risultati intermedi incoraggianti sulla sicurezza dal suo studio di Fase 2a in corso su GRI-0621 per il trattamento della Fibrosi Polmonare Idiopatica (IPF). Il Comitato Indipendente di Monitoraggio dei Dati ha raccomandato di continuare lo studio come pianificato, senza preoccupazioni di sicurezza identificate nei primi 12 pazienti valutati.
Lo studio valuta GRI-0621, un agonista duale RAR-βɣ somministrato per via orale a 4,5 mg una volta al giorno. I risultati iniziali mostrano che il farmaco è sicuro e ben tollerato, senza iperlipidemia osservata nei pazienti valutati. Il trial di Fase 2a arruolerà circa 36 soggetti in un rapporto di 2:1 (GRI-0621 vs. placebo) per un periodo di trattamento di 12 settimane.
Il principale obiettivo dello studio si concentra sulla sicurezza e tollerabilità, con obiettivi secondari che includono cambiamenti nei biomarcatori sierici e attività farmacodinamica. I dati intermedi sui biomarcatori sono attesi nel secondo trimestre del 2025, con risultati preliminari previsti nel terzo trimestre del 2025.
GRI Bio (NASDAQ: GRI) ha informado resultados interinos alentadores sobre la seguridad de su estudio en curso de Fase 2a sobre GRI-0621 para el tratamiento de la Fibrosis Pulmonar Idiopática (IPF). El Comité Independiente de Monitoreo de Datos recomendó continuar el estudio según lo planeado, sin preocupaciones de seguridad identificadas en los primeros 12 pacientes evaluados.
El estudio evalúa GRI-0621, un agonista dual de RAR-βɣ administrado por vía oral a 4,5 mg una vez al día. Los resultados iniciales muestran que el fármaco es seguro y bien tolerado, sin hiperlipidemia observada en los pacientes evaluados. El ensayo de Fase 2a inscribirá aproximadamente 36 sujetos en una proporción de 2:1 (GRI-0621 vs. placebo) durante un período de tratamiento de 12 semanas.
El objetivo principal del estudio se centra en la seguridad y tolerancia, con objetivos secundarios que incluyen cambios en los biomarcadores séricos y actividad farmacodinámica. Se esperan datos interinos de biomarcadores en el segundo trimestre de 2025, con resultados preliminares anticipados en el tercer trimestre de 2025.
GRI Bio (NASDAQ: GRI)는 GRI-0621의 특발성 폐섬유증(IPF) 치료를 위한 진행 중인 2a상 연구에서 안전성에 대한 고무적인 중간 결과를 보고했습니다. 독립 데이터 모니터링 위원회는 첫 12명의 평가된 환자에서 안전성 문제를 확인하지 못한 채 연구를 계획대로 계속할 것을 권장했습니다.
이 연구는 하루에 한 번 4.5mg의 경구 투여로 GRI-0621, RAR-βɣ 이중 작용제를 평가합니다. 초기 결과는 이 약물이 안전하고 잘 견딜 수 있으며, 평가된 환자에서 고지혈증이 관찰되지 않았음을 보여줍니다. 2a상 시험은 12주 치료 기간 동안 2:1 비율(GRI-0621 대 위약)로 약 36명의 피험자를 모집할 예정입니다.
연구의 주요 목표는 안전성과 내약성에 중점을 두며, 이차 목표는 혈청 바이오마커의 변화와 약리역학적 활성을 포함합니다. 중간 바이오마커 데이터는 2025년 2분기에 예상되며, 주요 결과는 2025년 3분기에 예상됩니다.
GRI Bio (NASDAQ: GRI) a rapporté des résultats intermédiaires encourageants concernant la sécurité de son étude en cours de Phase 2a sur GRI-0621 pour le traitement de la Fibrose Pulmonaire Idiopathique (IPF). Le Comité Indépendant de Surveillance des Données a recommandé de poursuivre l'étude comme prévu, sans préoccupations de sécurité identifiées chez les 12 premiers patients évalués.
L'étude évalue GRI-0621, un agoniste dual RAR-βɣ administré par voie orale à 4,5 mg une fois par jour. Les résultats préliminaires montrent que le médicament est sûr et bien toléré, sans hyperlipidémie observée chez les patients évalués. L'essai de Phase 2a recrutera environ 36 sujets dans un rapport de 2:1 (GRI-0621 contre placebo) pour une période de traitement de 12 semaines.
Le principal objectif de l'étude se concentre sur la sécurité et la tolérabilité, avec des objectifs secondaires incluant des changements dans les biomarqueurs sériques et l'activité pharmacodynamique. Des données intermédiaires sur les biomarqueurs sont attendues au deuxième trimestre 2025, avec des résultats préliminaires anticipés au troisième trimestre 2025.
GRI Bio (NASDAQ: GRI) hat ermutigende Zwischenresultate zur Sicherheit aus seiner laufenden Phase 2a-Studie zu GRI-0621 zur Behandlung der idiopathischen Lungenfibrose (IPF) berichtet. Das unabhängige Datenüberwachungskomitee empfahl, die Studie wie geplant fortzusetzen, da bei den ersten 12 bewerteten Patienten keine Sicherheitsbedenken festgestellt wurden.
Die Studie bewertet GRI-0621, einen dualen Agonisten von RAR-βɣ, der einmal täglich oral in einer Dosis von 4,5 mg verabreicht wird. Erste Ergebnisse zeigen, dass das Medikament sicher und gut verträglich ist, ohne dass bei den bewerteten Patienten Hyperlipidämie beobachtet wurde. Die Phase 2a-Studie wird voraussichtlich etwa 36 Probanden im Verhältnis 2:1 (GRI-0621 vs. Placebo) für einen Behandlungszeitraum von 12 Wochen einschließen.
Der primäre Endpunkt der Studie konzentriert sich auf Sicherheit und Verträglichkeit, während sekundäre Endpunkte Änderungen der Serum-Biomarker und die pharmakodynamische Aktivität umfassen. Zwischenzeitliche Biomarker-Daten werden im 2. Quartal 2025 erwartet, während die endgültigen Ergebnisse im 3. Quartal 2025 erwartet werden.
- Positive safety profile with no concerns in first 12 patients
- No hyperlipidemia observed in treated patients
- Study proceeding as planned with IDMC approval
- Consistent toxicity profile with previous studies
- Final efficacy data not yet available
- Small initial patient sample size of 12 patients
- Full enrollment of 36 patients not yet completed
Insights
The favorable 2-week safety data for GRI-0621 represents a modest but important milestone in GRI Bio's clinical development program for IPF. With no safety concerns identified in the first 12 patients and normal lipid profiles maintained, the drug is clearing an essential early hurdle that allows the Phase 2a study to proceed as planned.
What makes these results particularly notable is how they contrast with the significant side effects seen with the only two currently approved IPF treatments. The clean safety profile, if maintained throughout the 12-week treatment period, could potentially offer a competitive advantage in this indication where treatment adherence is challenged by tolerability issues.
However, investors should maintain perspective on what this data actually represents. This is strictly a safety readout with no efficacy signals yet reported. The upcoming biomarker data in Q2 and topline results in Q3 2025 will be far more consequential in determining GRI-0621's potential. The study's focus on iNKT cell inhibition represents a novel mechanism in IPF, which could differentiate it from existing therapies if efficacy is demonstrated.
Given GRI Bio's modest
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) (“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 interim safety results from its ongoing Phase 2a study evaluating GRI-0621 for the treatment of Idiopathic Pulmonary Fibrosis (“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 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.
Marc Hertz, PhD, Chief Executive Officer of GRI Bio commented, “While 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’s 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.”
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.
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.
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
FAQ
What are the interim safety results of GRI Bio's Phase 2a IPF study?
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