Aldeyra ADX-629 achieves statistically significant improvement in liver function

Aldeyra (ALDX) announced achievement of statistically significant improvement in liver function in patients treated with ADX-629, an investigational new drug candidate, and focused the RASP modulator product candidate pipeline on next-generation molecules ADX-248 and ADX-246. ADX-629, a signal-finding RASP modulator for proof-of-concept clinical testing, was administered orally for one month in a single-arm, multicenter Phase 2 clinical trial in four patients with mild to moderate alcohol-associated hepatitis. Relative to baseline, statistically significant improvement was observed in clinically relevant objective markers of hepatic function and inflammation, including the Model for End-Stage Liver Disease score, triglyceride levels and levels of C-Reactive Protein. No serious adverse events were reported, and no adverse events were deemed related to ADX-629. Based on Phase 1 clinical trial results generated to date in healthy volunteers, which suggest high levels of exposure following once-daily oral dosing, RASP modulator ADX-248 replaced ADX-743 for the treatment of metabolic inflammation, including obesity and hypertriglyceridemia; anticipated timing for the filing of an investigational new drug application was updated to 2026. Based on favorable results in an animal model of a dry form of age-related macular degeneration, RASP modulator ADX-246 replaced ADX-631 for the treatment of dry AMD; anticipated timing for the filing of an IND application was updated to 2026. Clinical development of ADX-629 was discontinued, pending further investigator-sponsored clinical testing in Sjogren-Larsson Syndrome, a RASP-mediated inborn error of metabolism. As a result of the pipeline updates, projected operational runway based on cash, cash equivalents, and marketable securities has been extended into the second half of 2027.