GRI Bio Advances GRI-0621 in Phase 2a IPF Study with Safety Focus
Promising Safety Results from GRI Bio's Phase 2a Study
The Independent Data Monitoring Committee has encouraged the continuation of the ongoing Phase 2a study of GRI-0621 without any safety concerns reported in the interim data.
Interim measurements reveal that GRI-0621 has been safe and well-tolerated among the initial 12 participants in the study.
Biomarker results are anticipated in the second quarter of 2025, with topline data expected in the third quarter of the same year.
Current treatments for Idiopathic Pulmonary Fibrosis (IPF) are limited, involving only two approved medications that carry significant side effects, leading to challenges in patient compliance and offering no survival benefits.
GRI Bio and Its Innovative Approach
GRI Bio, Inc. (NASDAQ: GRI), a biopharmaceutical company dedicated to developing cutting-edge treatments, reports significant interim results from its Phase 2a study investigating GRI-0621 for IPF.
GRI-0621 is a dual agonist targeting the RAR-?? receptor, which inhibits the activity of Type 1 Invariant NKT cells. In prior clinical trials, GRI-0621 showed promise in mitigating fibrosis across multiple disease models and enhancing liver function in patients.
The interim analysis conducted after two weeks indicated that GRI-0621 (administered as a 4.5 mg oral dose daily) is well-tolerated, with no adverse effects identified in lipid levels among the first 12 participants. LDL, HDL, and triglyceride levels remained stable, with no significant changes noted.
Leader's Insight on Clinical Developments
Marc Hertz, CEO of GRI Bio, expressed optimism about these initial results, stating they align with the company’s expectations. He emphasized the importance of safety data, reinforcing the potential of GRI-0621 to offer a much-needed treatment option for patients suffering from IPF, particularly given the limitations associated with existing therapies.
There is a significant unmet need in IPF management. The current approved medications primarily focus on slowing lung function decline and do not provide a cure or improve survival rates—factors that contribute to their limited use due to adverse side effects.
Details of the Phase 2a Study Design
The Phase 2a study is a randomized, double-blind, multi-center, placebo-controlled trial, aiming to enroll about 36 subjects with IPF. These participants will be allocated into two groups: one receiving GRI-0621 and the other receiving a placebo, following a 2:1 ratio.
Throughout the study, a thorough examination will be undertaken, including monitoring the safety and tolerability of GRI-0621 through clinical evaluations, vital signs, and adverse event reports over a 12-week administration period. Secondary objectives include measuring changes in serum biomarkers at specified intervals and assessing the pharmacokinetics of GRI-0621.
Future Developments on the Horizon
The company is poised to release vital interim biomarker data in the second quarter of 2025, with expectations of topline results becoming available in the subsequent quarter.
About GRI Bio, Inc.
GRI Bio is pioneering novel therapeutic strategies to alter the course of inflammatory, fibrotic, and autoimmune diseases. Their focus is on manipulating Natural Killer T cell activity to interrupt disease progression and restore immune balance. The company is progressing with advanced drug candidates such as GRI-0621, aimed at treating IPF, as well as a broader pipeline addressing diseases like systemic lupus erythematosus.
As a clinical-stage biopharmaceutical company, GRI Bio continues to expand its portfolio, leveraging a diverse library of proprietary compounds to fuel innovation.
Frequently Asked Questions
What is the primary focus of GRI Bio?
GRI Bio focuses on developing therapies for inflammatory, fibrotic, and autoimmune diseases, particularly through targeting Natural Killer T cells.
What are the results of the Phase 2a study for GRI-0621?
The interim results indicate that GRI-0621 is safe and well-tolerated, with no significant adverse effects noted in early trial participants.
What are the current treatment options for IPF?
Current options for IPF are limited to two approved medications that can slow the progression of the disease but do not offer a cure or improve survival rates.
When are the topline results from the Phase 2a study expected?
Topline results from the Phase 2a biomarker study are anticipated to be available in the third quarter of 2025.
Who can I contact for more information about GRI Bio?
For inquiries, you can reach out to Jenene Thomas at JTC Team, LLC via phone at (908) 824-0775 or email at GRI@jtcir.com.
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