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Aldeyra Therapeutics Reports First-Quarter 2020 Financial Results
and Announces New Clinical Programs
ADX-629 Expected to Begin Phase 2 Clinical Trials in COVID-19 Respiratory Compromise, Atopic Asthma, and Psoriasis in 2020
Type C Meeting Scheduled with FDA to Discuss Remaining NDA Requirements for Reproxalap in Dry Eye Disease
Results from Phase 3 INVIGORATE Trial of Reproxalap in Allergic Conjunctivitis Expected in First Half of 2021
Cash Runway Extended into 2022
Management to Host Conference Call at 8:00 a.m. ET Today
Lexington, Mass., May 7, 2020 Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a clinical-stage biotechnology company focused on the development of novel therapies with the potential to improve the lives of patients with immune-mediated diseases, today reported financial results for the first quarter ended March 31, 2020, announced new clinical trials in systemic inflammatory diseases, and provided an update on ocular disease programs.
Based on the success of the novel RASP inhibitor ADX-629 in Phase 1 clinical testing, we are pleased to announce a new comprehensive clinical initiative in systemic inflammatory diseases, complementing our late-stage pipeline in ocular disease, said Todd C. Brady, M.D., Ph.D., President and CEO of Aldeyra. Although the COVID-19 pandemic has affected clinical trial enrollment timelines, our cash position remains strong, and we are extending our projected cash runway guidance into 2022.
New Clinical Programs in Systemic Inflammatory Diseases
Aldeyra plans to assess the activity of ADX-629 in three types of severe inflammation: cytokine release syndrome, autoimmune disease, and allergy. In preclinical models, ADX-629 treatment reduced levels of TH1, TH2, and TH17-related cytokines, suggesting potential activity across a broad array of inflammatory diseases. The timing of clinical trial initiation depends, in part, on restrictions related to COVID-19, the availability of clinical research facilities and staffing, and the ability to recruit patients.
COVID-19 Respiratory Compromise: A Phase 2 clinical trial of ADX-629 is expected in subjects with COVID-19-associated respiratory compromise, defined as hypoxia and pulmonary radiographic involvement, immediately following admission to the hospital. Severe inflammation, characterized in part by cytokine release syndrome, leads to acute respiratory distress syndrome and other conditions that require mechanical ventilation. The clinical trial, contingent on
The following information was filed by Aldeyra Therapeutics, Inc. (ALDX) on Thursday, May 7, 2020 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-Q Quarterly Report statement of earnings and operation as management may choose to highlight particular information in the press release.
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