공시 • Oct 28
Aldeyra Therapeutics, Inc. Announces Positive Results from Phase 2 Clinical Trial in Alcohol-Associated Hepatitis, Focuses Rasp Product Candidate Pipeline on Next-Generation Molecules
Aldeyra Therapeutics, Inc. announced positive results from Phase 2 Clinical Trial in Alcohol-Associated Hepatitis, which focuses 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. Consistent with clinical trials in patients with atopic dermatitis, psoriasis, chronic cough, and asthma, the orally administered RASP modulator ADX-629, relative to baseline, demonstrated activity in improving liver function and reducing inflammation in patients with moderate alcohol-associated hepatitis, a chronic and challenging disease that proves difficult to manage in many cases, stated Todd C. Brady, M.D., Ph.D., President and Chief Executive Officer of Aldeyra. The RASP modulator product candidate pipeline was updated: 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 (IND) application was updated to 2026. Based on favorable results in an animal model of a dry form of age-related macular degeneration (dry AMD), RASP modulator AD X-246 replaced ADX-631 for the treatment of dry AMD; anticipated timing for the filing the filing of an IND application was updated to 2026; anticipated timing for the filing to 2026. Based on favourable results in an animal model of an dry form of age-related Macular degeneration (dry AMD"), RASP modulatorADX-246 replaced ADX- 631 for the treatment of dry Advanced AMD; anticipated timing for the filed of an IND application was updated. The approach is to develop pharmaceuticals that modulate protein systems, instead of directly inhibiting or activating single protein targets, with the goal of optimizing multiple pathways at once while minimizing toxicity. This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding: the goals, opportunity, and potential for Aldeyra'sRASP modulator product candidates and pipeline; the outcome and timing of any clinical trials of Aldeyra's RASP modulator product candidates; anticipated timing of regulatory filings; and Aldeyra's projected cash runway. All of Aldeyra's development timelines may be subject to adjustment depending on recruitment rate, regulatory review, preclinical and clinical results, funding, and other factors that could delay the initiation, enrollment, or completion of clinical trials. important factors that could cause actual results to differ materially from those reflected in Aldeyra's forward-looking statements include, among others, the timing of enrollment, commencement and completion of preclinical studies and clinical trials conducted by Aldeyra and its development partners; delay in or failure to obtain regulatory approval of Aldeyra's product candidates, including as a result of the FDA not accepting Aldeyra's regulatory filings, issuing a complete response letter, or requiring additional clinical trials or data prior to review or approval of such filings or in connection with resubmissions of such filings; the ability to maintain regulatory approval of Aldeyra' product candidates, and the labeling for any approved products; the risk that prior results, such as signals of safety, activity, or durability of effect, observed from preclinical or clinical trials, will not be replicated or will not continue in ongoing or future studies or clinical trials involving Aldeyra's product candidates in clinical trials involving Aldeyra' product candidates in clinical trials focused on the same or different indications; the scope, progress, expansion, and costs of developing and commercializing Aldeyra's product candidates.