GRI Bio has reached a significant milestone in its clinical development program, completing enrollment for the interim analysis of its Phase 2a trial evaluating GRI-0621 in patients with idiopathic pulmonary fibrosis (IPF). The company has randomized 24 out of a planned 36 patients, meeting requirements for the 6-week interim review in this potentially groundbreaking study targeting a serious disease with limited treatment options.
The Phase 2a trial is designed as a randomized, double-blind, placebo-controlled, multi-center study where participants receive either a daily oral dose of 4.5 mg GRI-0621 or placebo in a 2:1 ratio for 12 weeks. The study includes a specialized sub-study evaluating NKT cells in bronchoalveolar lavage (BAL) fluid of eligible participants.
"We are pleased with the progress made in this Phase 2a biomarker study," said Marc Hertz, PhD, Chief Executive Officer of GRI Bio. "With the patient participation seen in the trial to date, we remain on track to report interim data later this quarter and topline results from this important study in the third quarter of this year."
Promising Safety Profile Emerges
Early safety data from the first 12 patients in the trial has been encouraging. A planned 2-week safety analysis revealed GRI-0621 appears to be safe and well-tolerated, with no significant changes observed in lipid levels, including LDL, HDL, and triglycerides. All values remained within normal ranges, prompting the independent analysis committee to recommend the study continue as planned.
This safety profile aligns with previous studies of tazarotene, a related oral compound that has been tested in over 1,700 patients for up to a year, providing additional confidence in GRI-0621's potential safety profile.
Addressing a Significant Unmet Need
IPF represents a substantial unmet medical need, characterized by progressive lung scarring that blocks oxygen transfer to the bloodstream. Currently, only two approved drugs exist for IPF treatment, both associated with significant side effects, limited patient compliance, and no demonstrated impact on overall survival.
GRI-0621 represents a novel approach to treating IPF. As a small molecule RAR-βγ dual agonist, it inhibits the activity of human invariant Natural Killer T (iNKT) cells, which play a critical role in propagating injury, inflammatory response, and fibrosis in various conditions.
"The momentum with enrollment, combined with our recently announced interim safety results, bolsters our confidence in the potential of GRI-0621 to provide a much needed treatment option for the treatment of IPF, where there remains significant unmet need," added Dr. Hertz.
Comprehensive Study Endpoints
The primary objective of the Phase 2a study is to evaluate GRI-0621's safety and tolerability through clinical laboratory tests, vital signs, and reported side effects after 12 weeks of treatment. Secondary objectives include:
- Changes in serum biomarkers at weeks 6 and 12
- Measurement of GRI-0621 blood levels to understand pharmacokinetics
- Assessment of the drug's impact on iNKT cell activity in blood and BAL fluid
Additional exploratory endpoints will examine pulmonary function and changes in gene expression and immune cell behavior over time.
Strong Financial Position Supports Development
GRI Bio has strengthened its financial position, raising $13.9 million in gross proceeds since the beginning of 2024. This funding extends the company's expected cash runway into mid-Q1 2025, sufficient to cover the planned interim data readout from the GRI-0621 Phase 2a biomarker study.
As of September 30, 2024, the company reported cash and cash equivalents of approximately $4.7 million, with a net loss of $6.3 million for the first nine months of 2024.
Expanding Intellectual Property Protection
In parallel with clinical development, GRI Bio has expanded intellectual property protection for its proprietary NKT cell modulators with the granting of a Japanese patent titled "Prevention and Treatment of Inflammatory Conditions." This strengthens the company's global IP position as it advances its innovative pipeline.
Looking Forward: Key Milestones
GRI Bio has outlined clear milestones for its GRI-0621 development program:
- Q1 2025: Report interim data from the Phase 2a biomarker study
- Q2 2025: Report topline results from the Phase 2a biomarker study
The company is leveraging the 505(b)(2) regulatory pathway for GRI-0621, potentially streamlining the development process.
"We continue to make fundamental progress on the development and regulatory fronts of our lead program GRI-0621 for the treatment of IPF," commented Dr. Hertz. "As we drive towards our interim data readout early next year, we are generating a robust and growing body of encouraging preclinical data with an innovative approach that we believe continues to validate and derisk our clinical approach."
