The primary endpoint of the clinical trial was safety. Over three months of treatment with ADX-2191, four patients received monthly injections and four patients received twice-monthly injections. "Based on compelling proof-of-concept clinical activity that is consistent with a well-defined mechanism of action supported by preclinical evidence, we are excited to meet with regulatory authorities to discuss initiation of a potentially pivotal Phase 2/3 clinical trial, as we enthusiastically advance ADX-2191 to the next stage of development."īased on preclinical evidence suggesting that methotrexate may facilitate the clearance of mutated rhodopsin 1, a protein critical for visual cycle function, an open-label, single-center Phase 2 clinical trial of ADX‑2191 was performed in eight retinitis pigmentosa patients with rhodopsin misfolding mutations. Brady, M.D., Ph.D., President and CEO of Aldeyra. "The improvement in retinal function relative to baseline observed in this retinitis pigmentosa clinical trial of ADX-2191 may offer hope to patients that today have no therapeutic options," stated Todd C. Relative to baseline, the clinical trial demonstrated statistically significant improvement in retinal function across a number of different physiological and psychophysical assessments.
(Nasdaq: ALDX) (Aldeyra), a biotechnology company devoted to discovering and developing innovative therapies designed to treat immune-mediated diseases, today announced positive top-line results from the Phase 2 clinical trial of intravitreal ADX-2191 (methotrexate injection, USP), an investigational drug candidate, in patients with retinitis pigmentosa. LEXINGTON, Mass., June 29, 2023-( BUSINESS WIRE)- Aldeyra Therapeutics, Inc. Planned Phase 2/3 Clinical Trial to be Discussed with Regulatory AuthoritiesĬompany to Discuss Results in Conference Call and Webcast at 8:00 a.m. Best Corrected and Low‑Light Visual Acuity Statistically Significantly ImprovedĪs Assessed by Electroretinography, Time to Retinal Response Statistically Significantly ImprovedĪs Assessed by Macular and Dark-Adapted Perimetry, Retinal Sensitivity Statistically Significantly ImprovedĪDX‑2191 Was Well Tolerated and No Safety Concerns Were Identified
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