GRI Bio Completes Enrollment in Phase 2a Study of GRI-0621 for the Treatment of Idiopathic Pulmonary Fibrosis (鈥淚PF鈥�)
GRI Bio (NASDAQ: GRI) has completed patient enrollment in its Phase 2a clinical trial evaluating GRI-0621 for the treatment of Idiopathic Pulmonary Fibrosis (IPF). The study enrolled approximately 35 subjects randomized in a 2:1 ratio to receive either GRI-0621 4.5mg or placebo once daily for 12 weeks.
The company reported positive interim safety results, with GRI-0621 demonstrating safety and tolerability in both 2-week (12 patients) and 6-week (24 patients) analyses. Notably, no hyperlipidemia was observed in treated patients, and interim biomarker results from the first 12 subjects at 2 weeks suggested potential anti-fibrotic effects.
The study's primary endpoint focuses on safety and tolerability after 12 weeks of treatment, with secondary endpoints including changes in serum biomarkers, pharmacokinetics, and pharmacodynamic activity. The company expects to report 6-week interim biomarker data in July 2025 and topline results in Q3 2025.
GRI Bio (NASDAQ: GRI) ha completato il reclutamento dei pazienti per il suo studio clinico di Fase 2a che valuta GRI-0621 nel trattamento della Fibrosi Polmonare Idiopatica (IPF). Lo studio ha arruolato circa 35 soggetti randomizzati con un rapporto 2:1 per ricevere GRI-0621 4,5 mg o placebo una volta al giorno per 12 settimane.
L'azienda ha riportato risultati preliminari positivi sulla sicurezza, con GRI-0621 che ha dimostrato sicurezza e tollerabilit脿 sia nelle analisi a 2 settimane (12 pazienti) che a 6 settimane (24 pazienti). In particolare, nei pazienti trattati non 猫 stata osservata iperlipidemia e i risultati preliminari dei biomarcatori dai primi 12 soggetti a 2 settimane hanno suggerito potenziali effetti antifibrotici.
L'endpoint primario dello studio 猫 la sicurezza e tollerabilit脿 dopo 12 settimane di trattamento, mentre gli endpoint secondari includono variazioni nei biomarcatori sierici, farmacocinetica e attivit脿 farmacodinamica. L'azienda prevede di comunicare i dati preliminari sui biomarcatori a 6 settimane a luglio 2025 e i risultati principali nel terzo trimestre del 2025.
GRI Bio (NASDAQ: GRI) ha completado la inscripci贸n de pacientes en su ensayo cl铆nico de Fase 2a que eval煤a GRI-0621 para el tratamiento de la Fibrosis Pulmonar Idiop谩tica (IPF). El estudio incluy贸 aproximadamente 35 sujetos asignados aleatoriamente en una proporci贸n 2:1 para recibir GRI-0621 4,5 mg o placebo una vez al d铆a durante 12 semanas.
La compa帽铆a inform贸 resultados interinos positivos de seguridad, con GRI-0621 demostrando seguridad y tolerabilidad tanto en los an谩lisis a 2 semanas (12 pacientes) como a 6 semanas (24 pacientes). Cabe destacar que no se observ贸 hiperlipidemia en los pacientes tratados, y los resultados interinos de biomarcadores de los primeros 12 sujetos a las 2 semanas sugirieron posibles efectos antifibr贸ticos.
El objetivo principal del estudio es evaluar la seguridad y tolerabilidad tras 12 semanas de tratamiento, mientras que los objetivos secundarios incluyen cambios en biomarcadores s茅ricos, farmacocin茅tica y actividad farmacodin谩mica. La compa帽铆a espera informar los datos interinos de biomarcadores a las 6 semanas en julio de 2025 y los resultados principales en el tercer trimestre de 2025.
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GRI Bio (NASDAQ : GRI) a termin茅 le recrutement des patients pour son essai clinique de phase 2a 茅valuant GRI-0621 dans le traitement de la fibrose pulmonaire idiopathique (FPI). L'茅tude a inclus environ 35 sujets randomis茅s selon un ratio 2:1 pour recevoir soit GRI-0621 4,5 mg, soit un placebo une fois par jour pendant 12 semaines.
La soci茅t茅 a rapport茅 des r茅sultats interm茅diaires positifs en mati猫re de s茅curit茅, avec GRI-0621 d茅montrant s茅curit茅 et tol茅rabilit茅 lors des analyses 脿 2 semaines (12 patients) et 脿 6 semaines (24 patients). Notamment, aucune hyperlipid茅mie n'a 茅t茅 observ茅e chez les patients trait茅s, et les r茅sultats interm茅diaires des biomarqueurs des 12 premiers sujets 脿 2 semaines ont sugg茅r茅 des effets antifibrotiques potentiels.
Le crit猫re principal de l'茅tude porte sur la s茅curit茅 et la tol茅rabilit茅 apr猫s 12 semaines de traitement, les crit猫res secondaires incluant les modifications des biomarqueurs s茅riques, la pharmacocin茅tique et l'activit茅 pharmacodynamique. La soci茅t茅 pr茅voit de communiquer les donn茅es interm茅diaires des biomarqueurs 脿 6 semaines en juillet 2025 et les r茅sultats principaux au troisi猫me trimestre 2025.
GRI Bio (NASDAQ: GRI) hat die Patientenrekrutierung f眉r seine Phase-2a-Studie abgeschlossen, in der GRI-0621 zur Behandlung der idiopathischen pulmonalen Fibrose (IPF) untersucht wird. Die Studie schloss etwa 35 Probanden ein, die im Verh盲ltnis 2:1 randomisiert wurden, um entweder GRI-0621 4,5 mg oder Placebo einmal t盲glich 眉ber 12 Wochen zu erhalten.
Das Unternehmen berichtete 眉ber positive vorl盲ufige Sicherheitsdaten, wobei GRI-0621 in den Analysen nach 2 Wochen (12 Patienten) und 6 Wochen (24 Patienten) Sicherheit und Vertr盲glichkeit zeigte. Bemerkenswert ist, dass bei den behandelten Patienten keine Hyperlipid盲mie auftrat und die vorl盲ufigen Biomarkerdaten der ersten 12 Probanden nach 2 Wochen auf potenzielle antifibrotische Wirkungen hindeuteten.
Der prim盲re Endpunkt der Studie ist die Sicherheit und Vertr盲glichkeit nach 12 Wochen Behandlung, sekund盲re Endpunkte umfassen Ver盲nderungen der Serum-Biomarker, Pharmakokinetik und pharmakodynamische Aktivit盲t. Das Unternehmen erwartet, die vorl盲ufigen Biomarkerdaten nach 6 Wochen im Juli 2025 und die Hauptergebnisse im dritten Quartal 2025 zu berichten.
- Successful completion of patient enrollment for Phase 2a trial
- Positive 2-week and 6-week interim safety results showing GRI-0621 to be safe and well-tolerated
- Early biomarker data suggesting potential anti-fibrotic effect
- No hyperlipidemia observed in treated patients
- Independent Data Monitoring Committee (IDMC) recommended study continuation with no safety concerns
- Currently available IPF treatments have significant side-effects and limited patient compliance
- Existing IPF treatments show no impact on survival
Insights
GRI Bio's Phase 2a IPF trial completes enrollment with positive early safety data; key efficacy results coming in Q3 2025.
GRI Bio has reached a significant clinical milestone with the completion of enrollment in their Phase 2a study of GRI-0621 for Idiopathic Pulmonary Fibrosis (IPF). The company is targeting a substantial unmet medical need, as current IPF treatments are limited to just two approved drugs with significant side-effects, limited patient compliance, and no impact on survival.
The trial design shows methodological rigor with approximately 35 subjects randomized 2:1 to receive either GRI-0621 4.5mg or placebo daily for 12 weeks. The inclusion of a bronchoalveolar lavage fluid sub-study for up to 12 subjects provides a deeper mechanistic evaluation of NKT cell activity directly in the lung tissue.
Crucially, the pre-planned interim analyses at both 2 and 6 weeks have demonstrated that GRI-0621 is safe and well-tolerated in the first 12 and 24 patients evaluated, respectively. The absence of hyperlipidemia (measured by HDL, LDL, and triglyceride levels) is particularly noteworthy, as metabolic side effects can limit patient compliance in chronic treatments.
The most promising signal comes from the initial biomarker results showing that changes in PRO-C3 levels compared to placebo are "suggestive of anti-fibrotic effect" after just 2 weeks of treatment. PRO-C3 is a biomarker of collagen formation and fibrotic activity, so early movement here could indicate GRI-0621 is affecting the underlying disease pathology.
With 6-week interim biomarker results expected this month (July 2025) and full topline data in Q3 2025, GRI Bio is approaching critical inflection points that will determine GRI-0621's potential as a novel therapeutic option for IPF patients.
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
2- and 6-week interim safety results demonstrated GRI-0621 to be safe and well-tolerated in the first 12 and 24 patients evaluated, respectively
Results on track for 6-week interim biomarker analysis (n=24) in July 2025 and topline data in Q3 2025
LA JOLLA, CA, July 01, 2025 (GLOBE NEWSWIRE) -- (NASDAQ: GRI) (鈥淕RI Bio鈥� or the 鈥淐ompany鈥�), a biotechnology company advancing an innovative pipeline of Natural Killer T (鈥淣KT鈥�) cell modulators for the treatment of inflammatory, fibrotic and autoimmune diseases, today announced the completion of patient enrollment for its Phase 2a study evaluating GRI-0621 for the treatment of Idiopathic Pulmonary Fibrosis (鈥淚PF鈥�).
鈥淲e are pleased to complete enrollment of this important trial and take another step toward potentially providing a much needed treatment option for patients with IPF. Looking ahead, we remain on track to report 6-week interim biomarker results in July 2025, followed by topline data expected in the third quarter of this year. Our team is diligently working to bring this trial across the finish line and we look forward to providing updates in the near future,鈥� commented Marc Hertz, PhD, Chief Executive Officer of GRI Bio.
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 (鈥淏AL鈥�) 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. Hyperlipidemia, as assessed by LDL, HDL and triglyceride (TG) levels, was not seen in the 12 patients assessed at the 2-week visit nor the 24 patients assessed at the 6-week visit. There were no meaningful changes in HDL, LDL or TG levels in patients receiving GRI-0621 observed in either interim analysis. The interim analysis committee recommended the study should continue as planned following each interim analysis. The interim results show that GRI-0621鈥檚 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.
The Company expects to report 6-week interim biomarker data in July 2025. Topline results from the Phase 2a biomarker study are expected in the third quarter of 2025.
For more information about the Phase 2a study, please visit 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鈥檚 therapies are designed to target the activity of Natural Killer T (鈥淣KT鈥�) 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 (鈥渋NKT鈥�) cells play a critical role in propagating the injury, inflammatory response, and fibrosis observed in inflammatory and fibrotic indications. GRI Bio鈥檚 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 (鈥渄NKT鈥�) 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 鈥渇orward-looking statements鈥� within the meaning of the 鈥渟afe harbor鈥� provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words such as 鈥渁nticipate,鈥� 鈥渂elieve,鈥� 鈥渃ontemplate,鈥� 鈥渃ould,鈥� 鈥渆stimate,鈥� 鈥渆xpect,鈥� 鈥渋ntend,鈥� 鈥渟eek,鈥� 鈥渕ay,鈥� 鈥渕ight,鈥� 鈥減lan,鈥� 鈥減otential,鈥� 鈥減redict,鈥� 鈥減roject,鈥� 鈥渢arget,鈥� 鈥渁im,鈥� 鈥渟hould,鈥� 鈥渨ill,鈥� 鈥渨ould,鈥� or the negative of these words or other similar expressions. These forward-looking statements are based on the Company鈥檚 current beliefs and expectations. Forward-looking statements include, but are not limited to, statements regarding: the Company鈥檚 expectations with respect to development and commercialization of the Company鈥檚 product candidates, the timing of initiation or completion of clinical trials and availability of resulting data, the potential benefits and impact of the Company鈥檚 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鈥檚 beliefs and expectations regarding potential shareholder value, the Company鈥檚 beliefs and estimates about its cash and available resources and its ability to fund its planned operations through any particular date, the Company鈥檚 beliefs about the timing and outcome of regulatory approvals and potential regulatory approval pathways, and the Company鈥檚 expected milestones in 2025. 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鈥檚 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鈥檚 product development activities; (5) the inability of the Company to obtain and maintain regulatory clearance or approval for its respective product candidates, and any related restrictions and limitations of any cleared or approved product candidates; (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鈥檚 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鈥檚 estimates regarding expenses, future revenue, capital requirements and needs for and the ability to obtain additional financing; (11) the Company鈥檚 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鈥檚 filings with the U.S. Securities and Exchange Commission (the 鈥淪EC鈥�), including the risks and uncertainties described in the 鈥淩isk Factors鈥� section of the Company鈥檚 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:
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Jenene Thomas
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FAQ
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