- Top-Line Results from the Phase 2 Clinical Trial of ADX-2191 in Retinitis Pigmentosa Expected in the Second Quarter of 2023
- Top-Line Results from the Phase 2 Clinical Trial of ADX-629 in Chronic Cough Expected in the Second Quarter of 2023
- Top-Line Results from the Phase 3 INVIGORATE-2 Trial of Reproxalap in Allergic Conjunctivitis Expected in the Second Quarter of 2023
- NDA Priority Review PDUFA Date for ADX-2191 for the Treatment of Primary Vitreoretinal Lymphoma is June 21, 2023
- NDA PDUFA Date for Reproxalap for the Treatment of Dry Eye Disease is November 23, 2023
- Cash and Cash Equivalents of $165.0 Million as of March 31, 2023
LEXINGTON, Mass.--(BUSINESS WIRE)-- Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a biotechnology company devoted to discovering and developing innovative therapies designed to treat immune-mediated diseases, today reported recent corporate highlights and financial results for the quarter ended March 31, 2023.
“Aldeyra continues to build a robust pipeline of novel drug candidates for the treatment of immune-mediated diseases,” stated Todd C. Brady, M.D., Ph.D., President and Chief Executive Officer of Aldeyra. “Multiple regulatory and clinical catalysts are planned for the coming quarters, including PDUFA dates for ADX-2191 and reproxalap, top-line results from our Phase 2 clinical trials in retinitis pigmentosa and chronic cough, and top-line results from our Phase 3 INVIGORATE-2 trial in allergic conjunctivitis.”
Recent Corporate Highlights
- Enrollment Completed in the Phase 2 Clinical Trial of ADX‑2191 in Retinitis Pigmentosa: The open-label, single-center Phase 2 clinical trial enrolled a total of eight retinitis pigmentosa patients with rhodopsin gene mutations, including the P23H gene mutation. Patients receive either monthly or twice-monthly intravitreal doses of ADX‑2191 for three months. The primary endpoint of the trial is safety. Secondary endpoints include change from baseline in visual acuity; retinal function, as assessed by foveal microperimetry, electroretinography, and dark adaptation; and retinal morphology, as assessed by optical coherence tomography. ADX-2191, an investigational drug candidate, is a novel intravitreal formulation of methotrexate, which in preclinical models of retinitis pigmentosa facilitates the clearance of misfolded rhodopsin, a critical visual cycle protein susceptible to genetic mutation.1 Top-line results from the Phase 2 clinical trial are expected in the second quarter of 2023.
- Enrollment Completed in the Phase 2 Clinical Trial of ADX-629 in Chronic Cough: The multicenter, randomized, double-blind, placebo-controlled, two-period Phase 2 crossover trial enrolled 51 patients with refractory or unexplained chronic cough, which is often defined as a cough that persists for more than eight weeks. Patients were randomized to receive ADX-629 or placebo twice daily for two weeks, followed by a two-week washout period prior to crossing over to two weeks of treatment with ADX-629 or placebo, whichever was not received in the first period. The primary endpoint of the trial is safety. Secondary endpoints include awake cough frequency, 24-hour cough frequency, patient-reported cough severity, quality of life, and patient and clinician global impression of change. ADX-629, an investigational new drug candidate, is a novel, orally administered RASP (reactive aldehyde species) modulator for the potential treatment of systemic immune-mediated diseases. RASP were observed in a preliminary observational study to be elevated in the bronchioalveolar lavage fluid of patients with chronic cough,2 and may contribute to neurosensory dysfunction as well as inflammation. Top-line results from the Phase 2 clinical trial are expected in the second quarter of 2023.
- First Patient Enrolled in the Phase 2 Clinical Trial of ADX-629 in Atopic Dermatitis: The multicenter, adaptive, two-part Phase 2 clinical trial will evaluate the safety and efficacy of ADX‑629 alone and in combination with standard of care in adults with mild, moderate, or severe atopic dermatitis. In Part 1, approximately 10 patients will receive open-label ADX‑629 twice daily for three months. Outcomes will include improvement in Investigator Global Assessment and Eczema Area and Severity Index scores. In patients with atopic dermatitis, the pro-inflammatory RASP malondialdehyde is elevated compared to levels observed in healthy controls.3 Top-line results from Part 1 are expected in the second half of 2023. Pending the results of Part 1, Part 2 will randomize patients to receive either ADX‑629 or placebo treatment twice daily for three months.
- Enrollment Completed in the Phase 3 INVIGORATE-2 Clinical Trial of Reproxalap in Allergic Conjunctivitis: The randomized, double-masked, crossover, vehicle-controlled Phase 3 clinical trial enrolled 131 seasonal allergic conjunctivitis patients who were evaluated for 3.5 hours in an allergen chamber designed to simulate real-world pollen exposure. Consistent with pivotal trials of approved allergic conjunctivitis products, the primary endpoint of INVIGORATE-2 is patient-reported ocular itching. The protocol of INVIGORATE-2 is substantially identical to that of the Phase 3 INVIGORATE clinical trial and a Phase 2 clinical trial,4 both of which achieved the ocular itching endpoint (P