Aldeyra Advances RASP Platform for Inflammatory Diseases

Aldeyra Therapeutics, a leading biotech firm specializing in therapies for immune-mediated diseases, has made significant strides in advancing its RASP modulator platform. The company has outlined its progress in several clinical trials and regulatory submissions for its RASP modulators, ADX-629, ADX-246, and ADX-248.
The Phase 2 clinical trial for ADX-629, aimed at Sjögren-Larsson Syndrome, has shown promising biomarker responses in adults, prompting Aldeyra to plan an expansion to include pediatric patients. The company intends to submit this proposal to the FDA in 2024. Additionally, a Phase 2 clinical trial for ADX-629 in moderate alcoholic hepatitis has commenced, with preliminary results expected later in the year.
Aldeyra has also submitted an IND application for ADX-246 to the FDA, marking the beginning of a Phase 1 clinical trial in healthy volunteers. This trial is set to expand to encompass patients with atopic dermatitis. Furthermore, the company anticipates submitting an IND application for ADX-248 in 2024, with a Phase 1/2 clinical trial planned for patients with dry age-related macular degeneration and dark adaptation deficit.
In light of feedback from the FDA, Aldeyra has revised the clinical trial protocol and statistical analysis plan for reproxalap, which is being developed for dry eye disease. The company's focused pipeline includes the prioritization of key clinical indications for future development, with some previous programs being de-prioritized due to regulatory and feasibility issues.
Aldeyra's approach to treating immune-mediated diseases involves modulating the immune system with pharmaceuticals, rather than targeting single proteins, aiming to optimize multiple pathways and minimize toxicity. The company's product candidates, including ADX-629, ADX-246, and ADX-248, are RASP modulators with potential applications in treating a range of systemic and retinal diseases.
ADX-629, currently under development, has shown potential in treating various immune-mediated diseases, with no consistent adverse events identified in over 100 volunteers and patients. ADX-246, an analog of ADX-629, is set to begin clinical testing in 2024, with results expected by the year's end. ADX-248, designed for retinal diseases, is also slated for clinical testing in 2024.
Aldeyra's CEO, Dr. Todd C. Brady, expressed excitement about the company's progress, stating, "We anticipate 2024 to provide a variety of clinical-stage catalysts, as Aldeyra continues to progress its novel RASP platform." The company's commitment to innovation in immune-mediated disease treatment is evident in its robust pipeline and ongoing clinical trials.