GRI Bio Reports 6-Week Interim Lung Function Data in Ongoing Phase 2a Study in Idiopathic Pulmonary Fibrosis (“IPF”)
GRI Bio (NASDAQ: GRI) has reported encouraging 6-week interim lung function data from its Phase 2a study of GRI-0621 for Idiopathic Pulmonary Fibrosis (IPF) treatment. The data showed no decline in forced vital capacity (FVC) at 6 weeks compared to baseline in treated patients.
The study, involving 24 subjects, demonstrated positive biomarker changes suggesting anti-fibrotic effects, including decreased fibrosis formation markers and increased fibrosis resolution markers. The Independent Data Monitoring Committee (IDMC) reported no safety concerns and recommended continuing the study as planned.
The Phase 2a trial has fully enrolled approximately 35 subjects, randomized 2:1 to receive GRI-0621 4.5mg or placebo. Topline results are expected in Q3 2025.
GRI Bio (NASDAQ: GRI) ha comunicato risultati provvisori incoraggianti a 6 settimane sulla funzione polmonare dallo studio di Fase 2a su GRI-0621 per il trattamento della fibrosi polmonare idiopatica (IPF). I dati hanno mostrato assenza di riduzione della capacità vitale forzata (FVC) a 6 settimane rispetto al basale nei pazienti trattati.
Lo studio, condotto su 24 soggetti, ha evidenziato modifiche favorevoli nei biomarcatori compatibili con un effetto antifibrotico, tra cui la diminuzione dei marcatori di formazione della fibrosi e l'aumento dei marcatori di risoluzione della fibrosi. Il Comitato Indipendente per il Monitoraggio dei Dati (IDMC) non ha segnalato preoccupazioni sulla sicurezza e ha raccomandato di proseguire lo studio come previsto.
La sperimentazione di Fase 2a ha completato l'arruolamento di circa 35 soggetti, randomizzati 2:1 a ricevere GRI-0621 4,5 mg o placebo. I risultati principali sono attesi nel terzo trimestre del 2025.
GRI Bio (NASDAQ: GRI) ha informado datos provisionales alentadores a 6 semanas sobre la función pulmonar del estudio de fase 2a de GRI-0621 para el tratamiento de la fibrosis pulmonar idiopática (FPI). Los datos mostraron ninguna disminución de la capacidad vital forzada (FVC) a las 6 semanas respecto a la línea de base en los pacientes tratados.
El estudio, con 24 sujetos, presentó cambios favorables en biomarcadores que sugieren efectos antifibróticos, incluyendo la reducción de marcadores de formación de fibrosis y el aumento de marcadores de resolución de fibrosis. El Comité Independiente de Monitorización de Datos (IDMC) informó de ausencia de problemas de seguridad y recomendó continuar el ensayo según lo previsto.
El ensayo de fase 2a ha completado el reclutamiento con aproximadamente 35 sujetos, aleatorizados 2:1 para recibir GRI-0621 4,5 mg o placebo. Se esperan los resultados principales en el tercer trimestre de 2025.
GRI Bio (NASDAQ: GRI)는 특발성 폐섬유증(IPF) 치료제 GRI-0621에 대한 2상(2a) 연구의 6주 중간 폐기능 데이터가 고무적이라고 발표했습니다. 데이터는 치료군에서 기준선 대비 6주 시점에 강제 폐활량(FVC) 감소가 없었다고 나타냈습니다.
24명을 대상으로 한 이 연구는 섬유화 형성 마커 감소와 섬유 해소 마커 증가 등 항섬유화 효과를 시사하는 유리한 바이오마커 변화를 보였습니다. 독립적 데이터모니터링위원회(IDMC)는 안전성 문제 없음을 보고하며 계획대로 연구를 지속할 것을 권고했습니다.
이 2상 2a 시험은 약 35명의 피험자 등록을 완료했으며, 2:1로 무작위 배정되어 GRI-0621 4.5mg 또는 위약을 투여받습니다. 주요 결과는 2025년 3분기에 발표될 예정입니다.
GRI Bio (NASDAQ: GRI) a annoncé des données intermédiaires encourageantes à 6 semaines sur la fonction pulmonaire issues de son essai de phase 2a de GRI-0621 pour le traitement de la fibrose pulmonaire idiopathique (FPI). Les données ont montré aucune diminution de la capacité vitale forcée (CVF) à 6 semaines par rapport au niveau de référence chez les patients traités.
L'étude, portant sur 24 sujets, a montré des modifications positives de biomarqueurs suggérant un effet antifibrotique, notamment une baisse des marqueurs de formation de fibrose et une augmentation des marqueurs de résolution de la fibrose. Le comité indépendant de surveillance des données (IDMC) n'a signalé aucune préoccupation de sécurité et a recommandé de poursuivre l'étude comme prévu.
L'essai de phase 2a a recruté au total environ 35 sujets, randomisés 2:1 pour recevoir GRI‑0621 4,5 mg ou un placebo. Les résultats principaux sont attendus au troisième trimestre 2025.
GRI Bio (NASDAQ: GRI) hat ermutigende 6‑Wochen‑Zwischendaten zur Lungenfunktion aus der Phase‑2a‑Studie von GRI-0621 bei der Behandlung der idiopathischen Lungenfibrose (IPF) vorgelegt. Die Daten zeigten bei behandelten Patienten keinen Rückgang der forcierten Vitalkapazität (FVC) nach 6 Wochen gegenüber dem Ausgangswert.
Die Studie mit 24 Probanden wies günstige Biomarkerveränderungen auf, die auf antifibrotische Effekte hindeuten, darunter verringerte Marker für Fibrosebildung und erhöhte Marker für Fibroseauflösung. Das unabhängige Datenüberwachungskomitee (IDMC) meldete keine Sicherheitsbedenken und empfahl, die Studie wie geplant fortzusetzen.
Die Phase‑2a‑Studie hat vollständig etwa 35 Probanden rekrutiert, die 2:1 randomisiert GRI‑0621 4,5 mg oder Placebo erhalten. Die Topline‑Ergebnisse werden für Q3 2025 erwartet.
- No decline in lung function (FVC) observed at 6-week interim analysis
- Positive biomarker data suggesting anti-fibrotic effects
- No safety concerns reported by IDMC
- Study is fully enrolled with topline data expected in Q3 2025
- Small sample size of only 24 subjects for interim analysis
- Short duration of treatment may limit conclusive efficacy assessment
Insights
GRI Bio's Phase 2a interim data shows promising stability in lung function with biomarker improvements, though early-stage with limited sample size.
The 6-week interim analysis from GRI Bio's Phase 2a trial for GRI-0621 in IPF patients reveals stabilization of forced vital capacity (FVC) compared to baseline in the first 24 subjects. This builds upon previously reported positive biomarker data suggesting anti-fibrotic activity, with decreases in fibrosis formation markers and increases in fibrosis resolution markers, including enhanced degradation of crosslinked type III collagen in fibrotic tissue.
These findings, while preliminary, are encouraging since IPF typically progresses with a decline in lung function over time. However, as Dr. Maher correctly notes, the short duration and small sample size limit definitive conclusions about efficacy. The study's design includes approximately 35 subjects randomized 2:1 to receive either 4.5mg GRI-0621 or placebo daily for 12 weeks.
The safety profile appears favorable thus far, with no concerns identified by the Independent Data Monitoring Committee in two sequential reviews. This aligns with previous safety data from over 1,700 patients treated with oral tazarotene (related compound) for up to 52 weeks.
For context, the current IPF treatment landscape is limited to just two approved medications that have significant side effects, limited patient compliance, and no documented survival benefit. A novel therapy with improved tolerability and anti-fibrotic activity would address a substantial unmet need in this progressive, fatal lung disease.
The upcoming topline data in Q3 2025 will provide more definitive evidence regarding GRI-0621's efficacy, with important endpoints including 12-week safety/tolerability, biomarker changes, pharmacokinetics, and effects on iNKT cell activation in both blood and bronchoalveolar lavage fluid.
No decline in lung function observed at 6-week interim analysis
builds upon positive safety and biomarker data
Phase 2a study fully enrolled; Topline data on track for 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, Sept. 11, 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 6-week lung function results from its ongoing Phase 2a study evaluating GRI-0621 for the treatment of Idiopathic Pulmonary Fibrosis (“IPF”).
In the second interim analysis, lung function was assessed from the first 24 subjects at 6 weeks. GRI-0621 treated patients demonstrated no worsening of forced vital capacity (“FVC”) at 6 weeks compared to baseline, building upon the previously reported, six-week, positive interim serum biomarker data observed. Changes observed from baseline of biomarkers in GRI-0621 treated subjects are suggestive of an anti-fibrotic effect, with decreases in biomarkers of fibrosis formation and increases in biomarkers of fibrosis resolution, including an increase in degradation of crosslinked type III collagen found in fibrotic tissue. No safety concerns have been observed by the Independent Data Monitoring Committee (IDMC) review of the first 12 subjects at two weeks and the first 24 subjects at six weeks of treatment. IDMC has recommended to continue the study as planned.
“The 6-week interim analysis pulmonary function data in patients treated with GRI-0621 shows that there has been no decline in FVC over that time,” said Toby Maher, MD, PhD, Professor of Clinical Medicine, Keck School of Medicine, USC Los Angeles. “Given the short duration of treatment and small sample size, these findings are not unexpected. We look forward to seeing longer-term data, particularly given that the biomarker findings suggest a net anti-fibrotic effect of GRI-0621 in patients with Idiopathic Pulmonary Fibrosis.”
“The FVC data after 6 weeks of GRI-0621 treatment support the improvements in serum biomarkers of collagen remodeling reported earlier,” commented Marc Hertz, PhD, Chief Executive Officer of GRI Bio. “We look forward to our topline data expected later this quarter.”
The Phase 2a, randomized, double-blind, multi-center, placebo-controlled, parallel-design, 2-arm study enrolled approximately 35 subjects with IPF who were 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). 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 and the IDMC determined that the change from baseline in PRO-C3 of GRI-0621-treated patients compared to placebo patients was suggestive of anti-fibrotic effect. The pre-planned interim analysis for 6-week safety results demonstrated GRI-0621 (4.5mg orally once daily) to be safe and well-tolerated, and that changes in biomarkers of collagen turnover were suggestive of a decrease in collagen synthesis and an increase in collagen degradation in the first 24 patients evaluated per protocol. The interim analysis committee recommended the study should continue as planned following each interim analysis. 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.
Topline results from the Phase 2a biomarker study are expected in the third quarter of 2025. Additional flow cytometry and differential gene expression data are expected to be reported over the coming months.
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, including additional data from the Phase 2a trial of GRI-0621, 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, topline or interim data or trials will be indicative of results of later studies or clinical trials or final data, 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 future milestones, 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 its ability to obtain any expected patent term extensions, adjustments, exclusivities or disclaimers; 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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