Aldeyra Therapeutics Announces Positive Results from Phase 2 Clinical Trial in Alcohol-Associated Hepatitis, Focuses RASP Product Candidate Pipeline on Next-Generation Molecules

Core Insights - Aldeyra Therapeutics announced positive results from a Phase 2 clinical trial for ADX-629, showing statistically significant improvement in liver function in patients with alcohol-associated hepatitis [1][2][3] - The company is shifting its focus towards next-generation RASP modulators, specifically ADX-248 and ADX-246, for treating immune-mediated diseases [1][3][4] - The cash runway has been extended into the second half of 2027, allowing for continued development of its therapeutic pipeline [4][6] Clinical Trial Results - ADX-629 was administered orally for one month in a single-arm, multicenter Phase 2 clinical trial involving four patients with mild to moderate alcohol-associated hepatitis [2] - Statistically significant improvements were observed in the Model for End-Stage Liver Disease (MELD) score (P=0.001), triglyceride levels (P<0.0001), and C-Reactive Protein levels (P<0.0001) [2] - No serious adverse events were reported, indicating a favorable safety profile for ADX-629 [2] Pipeline Updates - ADX-248 has replaced ADX-743 for treating metabolic inflammation, with an Investigational New Drug (IND) application anticipated in 2026 [5] - ADX-246 has replaced ADX-631 for the treatment of dry age-related macular degeneration (AMD), with the IND application also expected in 2026 [5] - Clinical development of ADX-629 has been discontinued pending further testing in Sjögren-Larsson Syndrome [5] Financial Outlook - The operational runway based on cash, cash equivalents, and marketable securities has been extended into the second half of 2027, supporting ongoing and future projects [4][6] - The company is committed to developing a robust pipeline of novel therapeutics while maintaining fiscal prudence [6]