- Signs of Pharmacodynamic and Clinical Activity Generated Across Three Phase 2 Proof-of-Concept Clinical Trials in Patients with Immune-Mediated Disease; No Safety or Tolerability Issues Observed
- ADX-629 to Be Advanced to New Development Indications: Ethanol Toxicity, Chronic Cough, Minimal Change Disease, and Sjögren-Larsson Syndrome
- Novel RASP Modulators for Systemic and Retinal Disease Expected to Initiate Clinical Testing in 2023
- Live Audio Webcast of R&D Day Scheduled to Begin at 10:00 a.m. ET Today
LEXINGTON, Mass.--(BUSINESS WIRE)-- Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a biotechnology company discovering and developing innovative therapies for the treatment of immune-mediated diseases, today will announce at its 2022 Research & Development Day that three clinical trials of ADX-629, a first-in-class orally administered RASP modulator, generated signs of pharmacodynamic and clinical activity consistent with broad-based reduction in pathologic inflammation.
“The promising results exhibited by ADX-629 represent the first clinical data supportive of RASP modulation as a novel pharmacology for the potential treatment of systemic disease,” stated Todd C. Brady, M.D., Ph.D., President and CEO of Aldeyra. “Accordingly, we plan to advance our proprietary RASP modulator platform, which includes ADX-629 and other novel molecules, into new indications mediated by RASP, effecting a new milestone for Aldeyra as we continue to expand our focus to systemic and retinal diseases.”
Top-Line Data from Phase 2 Proof-of-Concept Trials of ADX-629
Autoimmune Disease: Psoriasis
Following treatment of ten moderate psoriasis patients with ADX-629 for 12 weeks, psoriasis area and severity index (PASI) scores were statistically significantly decreased (p=0.0008 vs. baseline at Week 12), and peak PASI 50% and PASI 75% responder percentages were 57% (p=0.001) and 25% (p=0.051), respectively. Investigator global assessment scores decreased over the duration of treatment (p=0.01 vs. baseline at Week 12). Lesional pan-gene expression analysis suggested a trend toward normalization of global gene expression patterns; by Week 12 no gene expression pathways in lesional tissue were dysregulated compared to non-lesional skin. Plasma levels of the commonly described pro-inflammatory RASP malondialdehyde were reduced relative to baseline as soon as four weeks after initiation of treatment (p=0.02).
Allergic Inflammation: Asthma
In a placebo-controlled crossover trial of eight mild asthma patients treated for 7 days, asthma symptom scores and sputum eosinophil cell counts were numerically reduced following treatment with ADX-629 relative to treatment with placebo. Compared to placebo treatment, treatment with ADX-629 led to statistically significant reductions in plasma levels of the pro-inflammatory cytokines IL-5 (p=0.02) and TNFα (p