GRI Bio Reports 6-Week Interim Biomarker Data in Ongoing Phase 2a Study in Idiopathic Pulmonary Fibrosis (“IPF”)
GRI Bio (NASDAQ: GRI) has reported encouraging 6-week interim biomarker data from its Phase 2a study of GRI-0621 for Idiopathic Pulmonary Fibrosis (IPF) treatment. The study, which has completed enrollment of approximately 35 subjects, showed that GRI-0621 treated patients demonstrated favorable reduction in fibrogenesis biomarkers and increased basement membrane remodeling.
The Independent Data Monitoring Committee (IDMC) has recommended continuing the study as planned, noting no safety concerns in the data reviewed. The trial remains blinded, with patients randomized in a 2:1 ratio for GRI-0621 4.5mg or placebo. The company expects to report topline results in Q3 2025, with additional pulmonary function test data expected in the coming weeks.
GRI Bio (NASDAQ: GRI) ha riportato dati preliminari incoraggianti a 6 settimane sui biomarcatori nel suo studio di Fase 2a su GRI-0621 per il trattamento della Fibrosi Polmonare Idiopatica (IPF). Lo studio, che ha completato l'arruolamento di circa 35 soggetti, ha mostrato che i pazienti trattati con GRI-0621 hanno evidenziato una riduzione favorevole dei biomarcatori della fibrogenesi e un aumento del rimodellamento della membrana basale.
Il Comitato Indipendente per il Monitoraggio dei Dati (IDMC) ha raccomandato di proseguire lo studio come previsto, segnalando assenza di problemi di sicurezza nei dati esaminati. Lo studio rimane in cieco, con i pazienti randomizzati in un rapporto 2:1 per GRI-0621 4,5 mg o placebo. L'azienda prevede di comunicare i risultati principali nel terzo trimestre 2025, con ulteriori dati sui test di funzionalità polmonare attesi nelle prossime settimane.
GRI Bio (NASDAQ: GRI) ha informado datos preliminares alentadores a 6 semanas sobre biomarcadores en su estudio de Fase 2a de GRI-0621 para el tratamiento de la Fibrosis Pulmonar Idiopática (IPF). El estudio, que ha completado la inscripción de aproximadamente 35 sujetos, mostró que los pacientes tratados con GRI-0621 demostraron una reducción favorable en biomarcadores de fibrogénesis y un aumento en la remodelación de la membrana basal.
El Comité Independiente de Monitoreo de Datos (IDMC) recomendó continuar el estudio según lo planeado, señalando no haber preocupaciones de seguridad en los datos revisados. El ensayo permanece ciego, con pacientes asignados aleatoriamente en una proporción 2:1 para GRI-0621 4.5 mg o placebo. La compañía espera reportar resultados principales en el tercer trimestre de 2025, con datos adicionales de pruebas de función pulmonar esperados en las próximas semanas.
GRI Bio (NASDAQ: GRI)는 특발성 폐섬유증(IPF) 치료를 위한 GRI-0621의 2a상 연구에서 6주간의 중간 바이오마커 데이터를 발표했습니다. 약 35명의 피험자 등록이 완료된 이 연구에서 GRI-0621 치료 환자들은 섬유생성 바이오마커가 유의하게 감소하고 기저막 재형성이 증가하는 긍정적인 결과를 보였습니다.
독립 데이터 모니터링 위원회(IDMC)는 검토한 데이터에서 안전성 문제 없음을 확인하며 연구를 계획대로 계속 진행할 것을 권고했습니다. 임상시험은 여전히 블라인드 상태로, 환자들은 GRI-0621 4.5mg 또는 위약에 대해 2:1 비율로 무작위 배정되었습니다. 회사는 2025년 3분기에 주요 결과를 발표할 예정이며, 추가 폐 기능 검사 데이터도 곧 공개될 예정입니다.
GRI Bio (NASDAQ : GRI) a publié des données intermédiaires encourageantes à 6 semaines sur les biomarqueurs dans son étude de phase 2a de GRI-0621 pour le traitement de la Fibrose Pulmonaire Idiopathique (IPF). L'étude, qui a terminé le recrutement d'environ 35 sujets, a montré que les patients traités par GRI-0621 ont présenté une réduction favorable des biomarqueurs de fibrogenèse et une augmentation du remodelage de la membrane basale.
Le Comité Indépendant de Surveillance des Données (IDMC) a recommandé de poursuivre l'étude comme prévu, notant aucune préoccupation de sécurité dans les données examinées. L'essai reste en aveugle, avec une randomisation des patients dans un rapport 2:1 pour GRI-0621 4,5 mg ou placebo. La société prévoit de communiquer les résultats principaux au troisième trimestre 2025, avec des données supplémentaires sur les tests de fonction pulmonaire attendues dans les semaines à venir.
GRI Bio (NASDAQ: GRI) hat ermutigende Zwischenwerte zu Biomarkern nach 6 Wochen aus seiner Phase-2a-Studie mit GRI-0621 zur Behandlung der Idiopathischen Lungenfibrose (IPF) berichtet. Die Studie, die die Einschreibung von etwa 35 Probanden abgeschlossen hat, zeigte, dass Patienten, die mit GRI-0621 behandelt wurden, eine günstige Reduktion der Fibrogenese-Biomarker und eine verstärkte Umgestaltung der Basalmembran aufwiesen.
Das unabhängige Datenüberwachungskomitee (IDMC) empfahl, die Studie wie geplant fortzusetzen und stellte keine Sicherheitsbedenken bei den überprüften Daten fest. Die Studie bleibt verblindet, mit Patienten, die im Verhältnis 2:1 für GRI-0621 4,5 mg oder Placebo randomisiert wurden. Das Unternehmen erwartet, Topline-Ergebnisse im dritten Quartal 2025 zu berichten, wobei in den kommenden Wochen zusätzliche Daten zur Lungenfunktionstests erwartet werden.
- None.
- Data is still early and based on a small subset of participants
- Study remains blinded without visibility into individual patient data
- More patient data needed to confirm anti-fibrotic effect
Insights
GRI Bio's Phase 2a interim data shows promising biomarkers for IPF treatment with favorable safety profile; full results expected Q3 2025.
The interim 6-week biomarker results from GRI Bio's Phase 2a study of GRI-0621 in Idiopathic Pulmonary Fibrosis (IPF) demonstrate encouraging early signals. The data from 24 subjects show GRI-0621 treatment is associated with a reduction in fibrogenesis biomarkers (PRO-C3 and PRO-C6) alongside a favorable fibrolytic profile measured as the ratio of collagen formation to degradation. These findings suggest GRI-0621 may potentially inhibit the progression of fibrosis while simultaneously promoting the resolution of existing fibrotic tissue.
Particularly noteworthy is the evidence of increased basement membrane remodeling (C1M, C3M, C4Ma3, and C6M) and the potential activation of repair mechanisms in treated patients compared to controls. These molecular changes align with GRI-0621's mechanism as an NKT cell modulator and are consistent with the 2-week interim data previously reported.
The Independent Data Monitoring Committee's recommendation to continue the trial without modifications is a positive safety indicator. While this dataset remains preliminary with a small sample size and the study is still blinded, the directional trends are promising for a disease with only two currently approved therapies, both having significant limitations in side effects, patient compliance, and survival impact.
The fully enrolled study will provide more definitive evidence in the upcoming topline results expected in Q3 2025, with additional pulmonary function test data anticipated in the near term. These functional measurements will be crucial to determine if the observed biomarker improvements translate to clinically meaningful benefits for patients. For a disease as devastating as IPF, with limited treatment options, these early signals warrant attention while maintaining appropriate caution about drawing conclusions before the complete dataset is available.
Biomarkers at 6-week interim analysis show a positive impact on fibrogenesis, fibrolysis and potentially the initiation of a repair response
The Independent Data Monitoring Committee (IDMC) has recommended to continue the study as planned as there are no safety concerns seen in the data reviewed
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, July 31, 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 biomarker results from its ongoing Phase 2a study evaluating GRI-0621 for the treatment of Idiopathic Pulmonary Fibrosis (“IPF”).
In the second interim analysis, biomarkers of fibrogenesis and fibrolysis, or the formation and degradation of collagen and extracellular matrix (ECM) turnover in fibrosis, were assessed from the first 24 subjects at 6 weeks. GRI-0621 treated patients demonstrated a favorable reduction in fibrogenesis biomarkers (PRO-C3 and PRO-C6) and a net fibrolytic profile shown as the ratio of collagen formation to collagen degradation (e.g., PRO-C3/CTX-III, PRO-C4/C4Ma3 and PRO-C6/C6M ratios). Taken together, GRI-0621 treated patients demonstrated increased basement membrane remodeling (C1M, C3M, C4Ma3, and C6M) and induction of a potential repair mechanism compared to patients in the control arm. Based on the available interim data reviewed, the IDMC has recommended the Phase 2a study evaluating GRI-0621 to continue as planned as there are no safety concerns seen to date and that more patient data is needed to confirm the anti-fibrotic effect of GRI-0621 treatment compared to the standard of care in the control arm and to assess whether the change in baseline of GRI-0621 patients compared to placebo patients is suggestive of pulmonary function improvement.
“These 6-week interim biomarker data, while early and based on a small subset of participants, continue to be encouraging. Although the study remains blinded and we do not yet have visibility into individual patient data, background anti-fibrotic use or demographic distribution, we are seeing promising directional signals with GRI-0621, including reduced fibrogenesis, increased fibrolysis and improvement in the remodeling rate, or net changes in ECM formation versus resolution. These findings remain consistent with the results seen at the 2-week interim analysis and provide further insight into the full potential of GRI-0621,” commented Marc Hertz, PhD, Chief Executive Officer of GRI Bio. “Our team remains focused on the successful execution of the study and look forward to reporting topline data later this year, and hope to be able to report findings regarding pulmonary function in the coming weeks.”
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 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. 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.
Additionally, interim biomarker results from the first 12 subjects at 2 weeks were reviewed by the IDMC and determined that the change from baseline in PRO-C3 of GRI-0621-treated patients compared to placebo patients is suggestive of anti-fibrotic effect. Based on the available interim data reviewed, the IDMC has recommended the Phase 2a study evaluating GRI-0621 to continue as planned as there are no safety concerns seen to date.
Topline results from the Phase 2a biomarker study are expected in the third quarter of 2025. Additional pulmonary function test data are expected to be reported in the coming weeks, as well as 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 2 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 (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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