GRI Bio Presents Positive Preclinical Data Demonstrating GRI-0621’s Ability to Inhibit Invariant Natural Killer T (iNKT) Cell Activity and Reduce Important Inflammatory and Fibrotic Drivers in Idiopathic Pulmonary Fibrosis (IPF)
GRI Bio (NASDAQ: GRI) presented positive preclinical data for its lead program GRI-0621 at the 22nd International Colloquium on Lung and Airway Fibrosis. The data demonstrated GRI-0621's ability to inhibit invariant Natural Killer T (iNKT) cell activity and reduce inflammatory and fibrotic drivers in Idiopathic Pulmonary Fibrosis (IPF).
Key findings include:
- Increased expression of pro-fibrotic factors in IPF patients
- Increased IFN-γ producing NKT cells in IPF patients
- GRI-0621 treatment improved inflammatory, fibrotic, and pathological features in a bleomycin model of pulmonary fibrosis
GRI Bio is currently conducting a Phase 2a biomarker study of GRI-0621 in IPF patients, with interim data expected in Q4 2024 and topline results in Q1 2025.
GRI Bio (NASDAQ: GRI) ha presentato dati preclinici positivi per il suo programma principale GRI-0621 durante il 22° Colloquio Internazionale sulla Fibrosi Polmonare e delle Vie Aeree. I dati hanno dimostrato la capacità di GRI-0621 di inibire l'attività delle cellule T naturali invariante (iNKT) e di ridurre i fattori infiammatori e fibrotici nella Fibrosi Polmonare Idiopatica (IPF).
I risultati chiave includono:
- Aumento dell'espressione di fattori pro-fibrotici nei pazienti con IPF
- Aumento delle cellule NKT produttrici di IFN-γ nei pazienti con IPF
- Il trattamento con GRI-0621 ha migliorato le caratteristiche infiammatorie, fibrotiche e patologiche in un modello di fibrosi polmonare indotto da bleomicina
Attualmente, GRI Bio sta conducendo uno per GRI-0621 nei pazienti con IPF, con dati intermedi attesi nel quarto trimestre del 2024 e risultati principali nel primo trimestre del 2025.
GRI Bio (NASDAQ: GRI) presentó datos preclínicos positivos para su programa líder GRI-0621 en el 22º Coloquio Internacional sobre Fibrosis Pulmonar y de las Vías Respiratorias. Los datos demostraron la capacidad de GRI-0621 para inhibir la actividad de las células T natural invariante (iNKT) y reducir los factores inflamatorios y fibrosos en la Fibrosis Pulmonar Idiopática (IPF).
Los hallazgos clave incluyen:
- Aumento de la expresión de factores pro-fibroticos en pacientes con IPF
- Aumento de las células NKT productoras de IFN-γ en pacientes con IPF
- El tratamiento con GRI-0621 mejoró las características inflamatorias, fibróticas y patológicas en un modelo de fibrosis pulmonar inducida por bleomicina
GRI Bio está llevando a cabo actualmente un estudio de biomarcadores de Fase 2a de GRI-0621 en pacientes con IPF, con datos intermedios esperados para el cuarto trimestre de 2024 y resultados finales en el primer trimestre de 2025.
GRI Bio (NASDAQ: GRI)는 제22회 국제 폐 및 기도 섬유증 콜로키움에서 GRI-0621의 긍정적인 전임상 데이터를 발표했습니다. 이 데이터는 GRI-0621이 불변 자연 살해 T(iNKT) 세포 활동을 억제하고 특발성 폐 섬유증(IPF)에서 염증 및 섬유화 요인을 줄일 수 있는 능력을 보여주었습니다.
주요 발견 사항은 다음과 같습니다:
- IPF 환자에서 섬유화 촉진 인자의 발현 증가
- IPF 환자에서 IFN-γ 생성 NKT 세포 증가
- GRI-0621 치료가 블레오마이신 모델의 폐 섬유증에서 염증적, 섬유화적, 병리학적 특징을 개선함
GRI Bio는 현재 IPF 환자를 대상으로 GRI-0621의 2a상 바이오마커 연구를 진행 중이며, 중간 데이터는 2024년 4분기, 최종 결과는 2025년 1분기로 예정되어 있습니다.
GRI Bio (NASDAQ: GRI) a présenté des données précliniques positives pour son programme phare GRI-0621 lors du 22e colloque international sur la fibrose pulmonaire et des voies respiratoires. Les données ont démontré la capacité de GRI-0621 à inhiber l'activité des cellules T natural killers invariantes (iNKT) et à réduire les facteurs inflammatoires et fibrotiques dans la fibrose pulmonaire idiopathique (IPF).
Les principaux résultats incluent :
- Augmentation de l'expression des facteurs pro-fibrotiques chez les patients atteints d'IPF
- Augmentation des cellules NKT produisant de l'IFN-γ chez les patients atteints d'IPF
- Le traitement avec GRI-0621 a amélioré les caractéristiques inflammatoires, fibrotiques et pathologiques dans un modèle de fibrose pulmonaire induite par la bléomycine
GRI Bio mène actuellement une étude de biomarqueurs de Phase 2a sur GRI-0621 chez des patients atteints d'IPF, avec des données intermédiaires prévues pour le 4e trimestre 2024 et des résultats globaux au 1er trimestre 2025.
GRI Bio (NASDAQ: GRI) hat beim 22. Internationalen Kolloquium über Lungen- und Atemwegsfibrose positive präklinische Daten für sein Hauptprojekt GRI-0621 präsentiert. Die Daten zeigten die Fähigkeit von GRI-0621, die Aktivität von invariantem natürlichen Killer-T-Zellen (iNKT) zu hemmen und entzündliche sowie fibrotische Faktoren bei idiopathischer pulmonaler Fibrose (IPF) zu reduzieren.
Wichtige Ergebnisse sind:
- Erhöhte Expression pro-fibrotischer Faktoren bei IPF-Patienten
- Erhöhte IFN-γ produzierende NKT-Zellen bei IPF-Patienten
- Die Behandlung mit GRI-0621 verbesserte entzündliche, fibrotische und pathologische Merkmale in einem Bleomycin-Modell der pulmonalen Fibrose
GRI Bio führt derzeit eine Phase-2a-Biomarker-Studie mit GRI-0621 bei IPF-Patienten durch, wobei Zwischenberichte für das 4. Quartal 2024 und Gesamtergebnisse für das 1. Quartal 2025 erwartet werden.
- Positive preclinical data demonstrating GRI-0621's ability to inhibit iNKT cell activity and reduce inflammatory and fibrotic drivers in IPF
- GRI-0621 treatment improved inflammatory, fibrotic, and pathological features in a bleomycin model of pulmonary fibrosis
- Phase 2a biomarker study of GRI-0621 in IPF patients is ongoing
- Interim data from Phase 2a study expected in Q4 2024
- Topline results from Phase 2a study expected in Q1 2025
- None.
Insights
The preclinical data for GRI-0621 in Idiopathic Pulmonary Fibrosis (IPF) is promising. Key findings show increased expression of pro-fibrotic factors and IFN-γ producing NKT cells in IPF patients compared to controls. GRI-0621 treatment in a bleomycin model of pulmonary fibrosis demonstrated improvements in several inflammatory and fibrotic features.
These results support the potential of iNKT cell inhibition as a therapeutic approach for IPF. However, it's important to note that preclinical success doesn't always translate to clinical efficacy. The upcoming Phase 2a biomarker study will be critical in validating these findings in humans.
The interim data expected in Q4 2024 and topline results in Q1 2025 will be significant milestones for GRI Bio. Positive results could position GRI-0621 as a potential new treatment option in a field with effective therapies. Investors should monitor these upcoming data releases closely, as they will likely have a substantial impact on GRI Bio's stock performance and future prospects in the competitive IPF market.
From a financial perspective, this preclinical data is a positive development for GRI Bio (NASDAQ: GRI). With a market cap of
The IPF market is substantial, with estimates suggesting it could reach
Investors should note that biotech companies at this stage are high-risk investments. Positive Phase 2a results could lead to substantial stock appreciation, while negative results could significantly impact the stock price negatively. The Q4 2024 interim data and Q1 2025 topline results will be important inflection points for the company's valuation.
Given the company's small market cap, successful development of GRI-0621 could lead to outsized returns. However, investors should be prepared for high volatility and consider the company's cash position and burn rate leading up to these key data readouts.
Data suggest that NKT cells are activated in airways in Idiopathic Pulmonary Fibrosis (IPF) patients and inhibition of iNKT cell activity can treat bleomycin-induced pulmonary fibrosis
Company advancing Phase 2a biomarker study of GRI-0621 in patients with IPF with interim data expected Q4 2024 and topline data in Q1 2025
Data presented at the 22nd International Colloquium on Lung and Airway Fibrosis
LA JOLLA, CA, Oct. 16, 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 poster titled, “Involvement of Type 1 Invariant Natural Killer T Cells in Driving Lung Fibrosis,” was presented by Vipin Kumar Chaturvedi, PhD, Chief Scientific Officer of GRI Bio highlighting results of an analysis of bronchoalveolar lavage (BAL) fluid from IPF patients and GRI-0621 in a treatment model of pulmonary fibrosis was presented at the 22nd International Colloquium on Lung and Airway Fibrosis (ICLAF 2024) being held October 12-16, 2024 in Athens, Greece.
Marc Hertz, PhD, Chief Executive Officer of GRI Bio, commented, “We continue to believe in our therapeutic targets, and this preclinical data provides further helpful insight into the effects of targeting the inhibition of iNKT cell activity in later stages of a preclinical model of IPF. We believe GRI-0621 has the potential to provide significant benefit to IPF patients and we remain focused on its advancement toward interim data and topline data from our Phase 2a biomarker study in the coming quarters.”
Key Highlights
- IPF patients had increased expression in whole BAL pellets of pro-fibrotic factors as Collagen 1-α1, osteopontin and TGF-β, as assessed by qPCR.
- Researchers detected an increase in IFN-γ producing NKT cells in IPF, compared to controls and confirmed iNKT cell phenotype in a second cohort, using an antibody against Vα24-Jα18 of the iNKT TCR.
- GRI-0621 treatment, administered during the fibrotic phase of the bleomycin model of pulmonary fibrosis, improved a majority of inflammatory, fibrotic and pathological features including a reduction in lung injury, myofibroblast activity, collagen deposition and fibrosis.
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.
GRI Bio is currently advancing its lead program GRI-0621, a small molecule RAR-βɣ dual agonist candidate that inhibits the activity of human iNKT cells, 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 fourth quarter of 2024 and topline results are expected in the first quarter of 2025.
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
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 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, and the Company’s beliefs and expectations regarding the sufficiency of its existing cash and cash equivalents to fund its planned operatings, its ability to raise additional funds, which may not be available to the Company on acceptable terms or at all, its ability to resume development of GRI-0863 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)
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