GRI Bio Receives Authorization to Conduct Phase 2a Biomarker Study Evaluating GRI-0621 in Australia
GRI Bio (NASDAQ: GRI) has received authorization from the Australian MHRA and HREC to initiate a Phase 2a biomarker study evaluating GRI-0621 for the treatment of Idiopathic Pulmonary Fibrosis (IPF) in Australia. This expands the global reach of their clinical development and is expected to accelerate enrollment. The company remains on track to report interim data in Q4 2024 and topline data in Q1 2025.
The study will enroll approximately 36 subjects with IPF, randomized in a 2:1 ratio for GRI-0621 4.5mg or placebo, administered orally once daily for 12 weeks. The primary endpoint is safety and tolerability, with secondary endpoints including changes in serum biomarkers, pharmacokinetics, and pharmacodynamic activity. The study also includes a sub-study examining NKT cells in bronchoalveolar lavage fluid.
GRI Bio (NASDAQ: GRI) ha ricevuto l'autorizzazione dalla MHRA e dall'HREC australiani per avviare uno studio biomarker di fase 2a che valuta GRI-0621 per il trattamento della Fibrosi Polmonare Idiopatica (IPF) in Australia. Questo espande la portata globale del loro sviluppo clinico e si prevede che acceleri l'arruolamento. L'azienda rimane in programma per riportare dati intermedi nel Q4 2024 e dati principali nel Q1 2025.
Lo studio arruolerà circa 36 soggetti con IPF, randomizzati in un rapporto 2:1 per GRI-0621 4.5mg o placebo, somministrato per via orale una volta al giorno per 12 settimane. L'endpoint primario è la sicurezza e la tollerabilità, mentre gli endpoint secondari includono cambiamenti nei biomarcatori sierici, farmacocinetica e attività farmacodinamica. Lo studio include anche uno studio secondario che esamina le cellule NKT nel fluido di lavaggio broncoalveolare.
GRI Bio (NASDAQ: GRI) ha obtenido autorización de la MHRA y el HREC australianos para iniciar un estudio de biomarcadores de fase 2a que evalúa GRI-0621 para el tratamiento de la Fibrosis Pulmonar Idiopática (IPF) en Australia. Esto amplía el alcance global de su desarrollo clínico y se espera que acelere la inscripción. La compañía sigue en camino de informar datos preliminares en el Q4 de 2024 y datos finales en el Q1 de 2025.
El estudio inscribirá aproximadamente 36 sujetos con IPF, aleatorizados en una proporción de 2:1 para GRI-0621 4.5mg o placebo, administrado por vía oral una vez al día durante 12 semanas. El objetivo principal es la seguridad y tolerabilidad, con objetivos secundarios que incluyen cambios en biomarcadores séricos, farmacocinética y actividad farmacodinámica. El estudio también incluye un sub-estudio que examina las células NKT en el líquido de lavado broncoalveolar.
GRI Bio (NASDAQ: GRI)는 호주 MHRA 및 HREC로부터 GRI-0621을 사용하여 특발性 폐섬유증(IPF) 치료를 평가하는 2a 단계 바이오마커 연구를 시작하도록 승인받았습니다. 이는 임상 개발의 글로벌 범위를 확대하며 등록을 가속화할 것으로 예상됩니다. 회사는 2024년 4분기에 중간 데이터, 2025년 1분기에 최종 데이터를 보고할 계획입니다.
이 연구에는 IPF 환자 약 36명이 등록되며, GRI-0621 4.5mg 또는 위약 군으로 2:1 비율로 무작위 배정되어 12주 동안 매일 한 번 경구 투여됩니다. 주요 Endpoint는 안전성과 내약성이며, 이차 Endpoint는 혈청 바이오마커의 변화, 약물 동태 및 약물 작용 활성 등을 포함합니다. 본 연구에는 기관지 폐포 세척액에서 NKT 세포를 조사하는 부연구도 포함됩니다.
GRI Bio (NASDAQ: GRI) a reçu l'autorisation de la MHRA et de l'HREC australiens pour lancer une étude biomarqueur de phase 2a évaluant GRI-0621 pour le traitement de la Fibrose Pulmonaire Idiopathique (IPF) en Australie. Cela élargit la portée mondiale de leur développement clinique et devrait accélérer l'inscription. L'entreprise reste sur la bonne voie pour rapporter des données intermédiaires au T4 2024 et des données principales au T1 2025.
L'étude recrute environ 36 sujets atteints d'IPF, randomisés dans un rapport de 2:1 pour GRI-0621 4,5 mg ou placebo, administré par voie orale une fois par jour pendant 12 semaines. L'objectif principal est la sécurité et la tolérabilité, avec des objectifs secondaires comprenant des changements dans les biomarqueurs sériques, la pharmacocinétique et l'activité pharmacodynamique. L'étude comprend également une sous-étude examinant les cellules NKT dans le liquide de lavage bronchoalvéolaire.
GRI Bio (NASDAQ: GRI) hat die Genehmigung der australischen MHRA und HREC erhalten, um eine Phase-2a-Studie zu Biomarkern zu beginnen, die GRI-0621 zur Behandlung von idiopathischer pulmonaler Fibrose (IPF) in Australien bewertet. Dies erweitert die globale Reichweite ihrer klinischen Entwicklung und wird voraussichtlich die Einschreibung beschleunigen. Das Unternehmen liegt im Zeitplan, Zwischenergebnisse im Q4 2024 und Hauptdaten im Q1 2025 zu berichten.
In der Studie werden voraussichtlich 36 Patienten mit IPF eingeschlossen, randomisiert im Verhältnis 2:1 für GRI-0621 4,5 mg oder Placebo, das einmal täglich über 12 Wochen oral verabreicht wird. Der primäre Endpunkt ist Sicherheit und Verträglichkeit, während die sekundären Endpunkte Veränderungen in Serum-Biomarkern, Pharmakokinetik und pharmakodynamische Aktivität umfassen. Die Studie beinhaltet außerdem eine Substudie zur Untersuchung von NKT-Zellen in Bronchoalveolarwäscheflüssigkeit.
- Authorization received to expand Phase 2a study to Australia, potentially accelerating enrollment
- On track to report interim data in Q4 2024 and topline data in Q1 2025
- Study design includes both primary and secondary endpoints to evaluate safety, tolerability, and efficacy
- None.
Insights
The authorization for GRI Bio's Phase 2a biomarker study in Australia is a positive development for the company's clinical program. This expansion into Australia, alongside ongoing trials in the U.S. and UK, may accelerate patient enrollment for their lead candidate GRI-0621 in treating Idiopathic Pulmonary Fibrosis (IPF).
Key points to consider:
- The study will enroll approximately 36 subjects, randomized 2:1 for GRI-0621 vs. placebo
- Primary endpoint focuses on safety and tolerability after 12 weeks of treatment
- Secondary endpoints include changes in serum biomarkers, pharmacokinetics and pharmacodynamic activity
- Interim data expected in Q4 2024, with topline data in Q1 2025
While this news doesn't guarantee success, it demonstrates progress in GRI Bio's clinical development strategy. The focus on biomarkers and multiple endpoints could provide valuable insights into GRI-0621's potential efficacy in IPF, a disease with treatment options and poor prognosis.
This clinical trial expansion is a positive step for GRI Bio, but investors should temper expectations. Key financial considerations include:
- Market opportunity: IPF is a rare disease, limiting the potential patient population but possibly commanding premium pricing if successful
- Cash burn: Expanding trials internationally likely increases expenses; investors should monitor the company's cash position and potential need for additional funding
- Timeline: With data readouts expected in Q4 2024 and Q1 2025, significant revenue generation is still years away if the drug proves successful
- Risk profile: As a small-cap biotech (
$1.29 billion market cap) focused on a single lead candidate, GRI Bio carries substantial risk
While the news is encouraging for GRI Bio's development progress, it's important to note that many biotech companies fail in Phase 2 trials. Investors should carefully consider the risk-reward profile and the company's ability to fund operations through key milestones before making investment decisions.
MHRA and HREC authorization in Australia further expands and will potentially accelerate enrollment in ongoing U.S. and UK Phase 2a biomarker study evaluating lead program GRI-0621 for the treatment of Idiopathic Pulmonary Fibrosis (“IPF”)
Company on track to report interim data Q4 2024 and topline data Q1 2025
LA JOLLA, CA, Sept. 26, 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 authorization of its Clinical Trial Application (CTA) by the Australian Medicines and Healthcare products Regulatory Agency (MHRA) and the Human Research Ethics Committee (HREC) to initiate a Phase 2a biomarker study evaluating GRI-0621 for the treatment of IPF in Australia.
“Receiving authorizations from the Australian MHRA and HREC further expands the global reach of our clinical development for GRI-0621 and enables us to have access to the right patients for the study which we believe will accelerate enrollment. We are pleased with the continued progress in the U.S. and UK with our ongoing Phase 2a study and remain on track to report important data readouts in Q4 2024 and Q1 2025,” Marc Hertz, PhD, Chief Executive Officer of GRI Bio.
IPF is a rare chronic progressive pulmonary disease with abnormal scarring of the lung blocking the movement of oxygen into the bloodstream. The architectural destruction of the lung results in breathlessness, significant decline in quality of life and an average untreated survival of 3.5 years from diagnosis. Currently available treatments for IPF are limited with only two approved drugs that come with significant side-effects, limited compliance and no impact on survival1.
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.
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, potential acceleration of enrollment, 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 stakeholder 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 2024, including the potential availability of clinical trial data, and the Company’s beliefs and expectations regarding the sufficiency of its existing cash and cash equivalents to fund its operating expenses 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
1 T. M. Maher et al., Global incidence and prevalence of idiopathic pulmonary fibrosis. Respir Res 22, 197 (2021)
FAQ
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