Summary of GRI Bio Conference Call Company Overview - Company: GRI Bio - Focus: Clinical stage biotech company targeting inflammatory fibrotic and autoimmune diseases through regulation of NKT cells [2][5] Lead Program - Product: GRI o six two one - Type: Type one invariant natural killer T cell antagonist - Indication: Treatment of idiopathic pulmonary fibrosis (IPF) - Current Stage: Phase 2a study with top line data expected in Q3 2025 [6][18] Mechanism of Action - NKT Cells: Critical lymphocytes involved in chronic inflammation and fibrosis - Therapeutic Approach: Inhibiting NKT cell activity to interrupt disease progression and restore immune homeostasis [5][8] - Biomarker Potential: Increased NKT cells correlate with worsening fibrotic disease, suggesting their role as a useful biomarker [9][39] Clinical Trial Details - Trial Design: - 36 patients, 2:1 randomization (24 on GRI o six two one, 12 on placebo) - Duration: 12 weeks, with primary endpoints focusing on safety and tolerability [16][18] - Enrollment Status: Approximately 80% enrolled, with interim data expected in Q2 2025 [18][22] Data and Results - Interim Analysis: Positive recommendation from the Independent Data Monitoring Committee (IDMC) after 12 patients completed two weeks [21] - Early Signals: Antifibrotic signal observed in pro-collagen type III (pro C3) after two weeks [21][26] Market Context - Market Size: IPF is an orphan indication; Nintanadib, one of the approved drugs, generated approximately $4 billion in sales last year [35] - Challenges: Current treatments slow disease progression but do not improve overall survival; significant side effects limit patient compliance [29][30] Competitive Landscape - Current Treatments: Nintanadib and Perfinetone are the two approved drugs, both with limitations in efficacy and tolerability [35][36] - Future Positioning: GRI o six two one aims to address the disease earlier in the inflammatory cascade compared to existing therapies [30][31] Regulatory Considerations - Expedited Approval: Potential for a single registration trial due to existing safety data from other indications [43][44] Pipeline Opportunities - Future Programs: GRI o eight zero three targeting type two NKT cells for systemic lupus erythematosus; additional 500 compounds in the library for future development [46][47] Conclusion - GRI Bio is positioned to potentially disrupt the IPF treatment landscape with GRI o six two one, focusing on early intervention in the inflammatory process and leveraging NKT cells as biomarkers for disease progression [5][39]
GRI Bio (GRI) Conference Transcript