GRI Bio Showcases GRI-0621’s Potential to Reduce Inflammation, Type 1 Cytokines and Reduce Hepatic Fibrosis in Idiopathic Pulmonary Fibrosis (IPF)
GRI Bio presented positive preclinical data for GRI-0621, its lead program targeting Idiopathic Pulmonary Fibrosis (IPF), at the 8th Annual Antifibrotic Drug Development Summit. The data showed that GRI-0621 reduces inflammation and fibrotic drivers in IPF. Key findings demonstrated increased iNKT cell activity correlating with fibrosis progression, while GRI-0621 administration inhibited pro-inflammatory cytokines and decreased neutrophil accumulation. The company is currently conducting a Phase 2a clinical trial for IPF treatment, with interim data expected in Q1 2025 and topline results in Q2 2025.
GRI Bio ha presentato dati preclinici positivi per GRI-0621, il suo programma principale mirato all'Fibrosi Polmonare Idiopatica (IPF), durante l'8° Summit Annuale sullo Sviluppo di Farmaci Antifibrotici. I dati hanno mostrato che GRI-0621 riduce l'infiammazione e i fattori fibrotici nell'IPF. I risultati chiave hanno dimostrato un'aumento dell'attività delle cellule iNKT correlata con la progressione della fibrosi, mentre l'amministrazione di GRI-0621 ha inibito le citochine pro-infiammatorie e ridotto l'accumulo di neutrofili. Attualmente la società sta conducendo uno studio clinico di Fase 2a per il trattamento dell'IPF, con dati intermedi attesi per il primo trimestre del 2025 e risultati finali nel secondo trimestre del 2025.
GRI Bio presentó datos preclínicos positivos para GRI-0621, su programa principal dirigido a la Fibrosis Pulmonar Idiopática (FPI), en la 8ª Cumbre Anual de Desarrollo de Medicamentos Antifibróticos. Los datos mostraron que GRI-0621 reduce la inflamación y los factores fibroticos en la FPI. Los hallazgos clave demostraron un aumento de la actividad de las células iNKT que se correlaciona con la progresión de la fibrosis, mientras que la administración de GRI-0621 inhibió las citoquinas proinflamatorias y disminuyó la acumulación de neutrófilos. La empresa está actualmente llevando a cabo un ensayo clínico de Fase 2a para el tratamiento de la FPI, con datos intermedios esperados para el primer trimestre de 2025 y resultados generales en el segundo trimestre de 2025.
GRI Bio는 GRI-0621에 대한 긍정적인 전임상 데이터를 발표했습니다. 이는 특발성 폐섬유증 (IPF)을 대상으로 하는 주요 프로그램으로, 8회 연례 항섬유화 약물 개발 정상회의에서 발표되었습니다. 데이터에 따르면 GRI-0621은 IPF에서 염증과 섬유화 인자를 줄입니다. 주요 발견은 섬유화 진행과 상관관계를 가지는 iNKT 세포 활동 증가를 보여주었으며, GRI-0621의 투여는 염증성 사이토카인을 억제하고 호중구 축적을 감소시켰습니다. 현재 이 회사는 IPF 치료를 위한 2a 상 임상 시험을 진행 중이며, 중간 데이터는 2025년 1분기에 예상되며, 전체 결과는 2025년 2분기에 발표될 예정입니다.
GRI Bio a présenté des données précliniques positives pour GRI-0621, son programme phare visant la fibrose pulmonaire idiopathique (FPI), lors du 8ème Sommet Annuel sur le Développement de Médicaments Antifibrotiques. Les données ont montré que GRI-0621 réduit l'inflammation et les facteurs fibrogènes dans la FPI. Les résultats clés ont démontré une augmentation de l'activité des cellules iNKT corrélée à la progression de la fibrose, tandis que l'administration de GRI-0621 a inhibé les cytokines pro-inflammatoires et diminué l'accumulation de neutrophiles. Actuellement, la société mène un essai clinique de Phase 2a pour le traitement de la FPI, avec des données intermédiaires attendues au premier trimestre 2025 et des résultats globaux au deuxième trimestre 2025.
GRI Bio präsentierte positive präklinische Daten für GRI-0621, sein Hauptprogramm zur Behandlung von idiopathischer Lungenfibrose (IPF), auf dem 8. jährlichen Gipfel zur Entwicklung antifibrotischer Medikamente. Die Daten zeigten, dass GRI-0621 Entzündungen und fibrotische Treiber in der IPF reduziert. Wichtige Ergebnisse zeigten, dass die Aktivität der iNKT-Zellen mit dem Fortschreiten der Fibrose korreliert, während die Verabreichung von GRI-0621 proinflammatorische Zytokine hemmt und die Neutrophilansammlung verringert. Das Unternehmen führt derzeit eine klinische Studie der Phase 2a zur Behandlung der IPF durch, deren Zwischenberichte im ersten Quartal 2025 und Gesamtergebnisse im zweiten Quartal 2025 erwartet werden.
- Positive preclinical data showing GRI-0621 reduces inflammation and fibrotic drivers in IPF
- GRI-0621 demonstrated improvement in inflammatory, fibrotic, and pathological features in experimental models
- Phase 2a clinical trial is ongoing with data readouts expected in Q1/Q2 2025
- None.
Insights
The preclinical data for GRI-0621 demonstrates compelling evidence for its potential in treating IPF. Key findings show that iNKT cells are significantly elevated in IPF patients and play a important role in disease progression. The drug's ability to reduce inflammatory markers, decrease neutrophil accumulation and inhibit pro-fibrotic cytokines including TGF-β represents a novel therapeutic approach.
The ongoing Phase 2a study, with results expected in Q2 2025, will be pivotal. Current IPF treatments like nintedanib have limitations and GRI-0621's unique mechanism targeting NKT cells could offer a new treatment paradigm. The oral administration route and positive preliminary safety data enhance its clinical potential.
The correlation between enhanced iNKT activity and fibrosis progression, coupled with the drug's demonstrated ability to improve multiple pathological features in preclinical models, suggests a promising therapeutic profile.
The IPF market represents a significant opportunity, with current treatments generating over
Key catalysts include interim data in Q1 2025 and topline results in Q2 2025. The positive preclinical data and clear mechanism of action reduce development risk. However, investors should note that success in preclinical models doesn't guarantee clinical efficacy and the company will need substantial funding to complete development.
Workshop, poster and oral presentation of data given as part of the 8th Annual Antifibrotic Drug Development (AFDD) Summit
Data demonstrate that NKT cells are activated in airways in IPF patients and inhibition of iNKT cell activity with GRI-0621 ameliorates pulmonary fibrosis in a preclinical model
Ongoing Phase 2 study with GRI-0621 in IPF patients to examine iNKT activity along with key biomarkers; Topline data readout expected in Q2 2025
LA JOLLA, CA, Nov. 21, 2024 (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 the presentation of positive preclinical data demonstrating its lead program GRI-0621 reduces important inflammatory and fibrotic drivers in Idiopathic Pulmonary Fibrosis (IPF).
The data were presented as part of an invited talk titled, "A New Approach to Inflammatory Diseases," delivered by Marc Hertz PhD, Chief Executive Officer of GRI Bio, at the 8th Annual Antifibrotic Drug Development (AFDD) Summit, held November 19-21, 2024, in Boston, MA.
“We were pleased to participate at this prestigious event and engage with thought leaders in the field and present our novel approach for the treatment of inflammatory diseases. There remains a significant unmet need for therapeutic solutions that halt disease progression of fibrotic diseases such as IPF. Based on the growing body of positive data demonstrated by our lead program GRI-0621, we believe we have a validated and derisked clinical approach to address that need,” commented Marc Hertz, PhD, Chief Executive Officer of GRI Bio. “We believe GRI-0621 has the potential to provide meaningful benefit to IPF patients and we look forward to advancing it development and realizing its full value.”
Key Highlights
- Enhanced iNKT activity correlates with progression of fibrosis in MASH patients and key proinflammatory genes in BAL from IPF patients
- iNKT cells are activated and accumulate in liver and lung in experimental fibrosis models
- iNKT promote Type 1, Type 2 and Type 3 immune pathways involved in fibrosis
- iNKT-deficient mice have reduced inflammatory damage and fibrosis
- Daily oral administration of GRI-0621 in experimental animals
- Inhibits key pro-inflammatory cytokines and inflammation
- Decreases accumulation of neutrophils and activation of pro-fibrotic fibroblasts
- Inhibits key fibrogenic cytokines including TGF-β
Additionally, the Company presented a poster titled, “Involvement of Type 1 Invariant Natural Killer T Cells in Driving Lung Fibrosis,” outlining flow cytometry and quantitative PCR analysis in bronchoalveolar lavage (BAL) fluid from IPF patients and healthy controls to characterize NKT cells. A bleomycin (3.0 IU/Kg via the intratracheal route) model was used with or without daily administration of nintedanib or a small molecule selective inhibitor of iNKT activity, GRI-0621, during the fibrotic phase to study the role of iNKT cells in pulmonary fibrosis in a treatment protocol.
Results highlighted in the poster demonstrated that IPF patients had increased expression of pro-fibrotic molecules in BAL, including Collagen 1-α1, osteopontin and TGF-β. There was an increase in IFN-γ producing CD45+CD3+CD56+ NKT cells in IPF patients compared to controls. In a second cohort, we confirmed the iNKT phenotype using an anti-Vα24-Jα18 TCR antibody. In the bleomycin model, GRI-0621 inhibition of iNKT cells improved a majority of inflammatory, fibrotic, and pathological features, including a reduction in lung injury, myofibroblast activity, collagen deposition, and fibrosis.
GRI Bio’s lead program, GRI-0621, is a small molecule RAR-βɣ dual agonist that inhibits the activity of human iNKT cells. In preliminary trials to date and previous 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 Company is currently advancing the development of GRI-0621 in a Phase 2a, randomized, double-blind, multi-center, placebo-controlled, parallel-design, 2-arm study for the treatment of IPF. Interim data from the Phase 2a biomarker study is expected in the first quarter of 2025 and topline results are expected in the second 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 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 1 invariant (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 NKT 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 about the timing and outcome of regulatory approvals and potential regulatory approval pathways, the Company’s expected milestones for the first half of 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 Nasdaq 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 28, 2024 and subsequently filed reports. 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
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