Aldeyra to Screen Clinical-Stage Compounds for Activity in COVID-19 Infection
LEXINGTON, Mass.--(BUSINESS WIRE)--Mar. 24, 2020 -- Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra) today announced that it will begin screening its library of novel reactive aldehyde species (RASP) inhibitors, including ADX-629 and reproxalap, for potential anti-inflammatory and antiviral activity in the treatment of COVID-19 infection.
ADX-629 and reproxalap are structurally related to chloroquine and hydroxychloroquine, drugs currently in clinical testing for the treatment of COVID-19 infection.
“We are committing scientific expertise and development resources associated with our RASP platform to help reduce the impact of the COVID-19 global healthcare crisis,” stated Todd C. Brady, M.D., Ph.D., President and CEO of Aldeyra. “Given the strong association between RASP and acute respiratory distress syndrome (ARDS), as well as the structural similarity of reproxalap and ADX-629 to chloroquines, we are researching the potential of our novel RASP inhibitors to mitigate the clinical severity of COVID-19 infection.”
Reproxalap1 and ADX-6292 have been shown to diminish inflammation in animal models of cytokine storm. Reproxalap has also demonstrated preliminary activity in a preclinical model of ARDS3.
Aldeyra also announced that, in response to a recent U.S. Department of Health and Human Services solicitation, Aldeyra has submitted a proposal to the Biomedical Advanced Research and Development Authority (BARDA) for the development of ADX-629 for the treatment of COVID-19 infection. ADX-629 has completed a single and multiple ascending dose Phase 1 clinical trial. Initiation of a Phase 2 clinical trial of ADX-629 in patients with immune-mediated disease is planned for the second half of 2020.
Aldeyra is also seeking healthcare industry partners that may be interested in testing ADX-629 pursuant to the U.S. Food and Drug Administration’s Emergency Use Authorization guidelines. Physicians wishing to use ADX-629 under a single patient Investigational New Drug (IND) application for Compassionate or Emergency Use should email Dr. James Gow, Senior Vice President of Clinical Development, at firstname.lastname@example.org.
“We believe that ADX-629 could potentially be an important tool for physicians treating patients who are experiencing ARDS associated with COVID-19, either as a single agent or as an adjunct to other therapies,” Dr. Brady stated.
ADX-629 is an orally administered RASP inhibitor with potential antiviral and anti-inflammatory activity. The compound has completed a single-ascending and multiple-ascending dose Phase 1 clinical trial in 85 subjects with no drug-related adverse events observed. ADX-629 is a member of the same chemical class as reproxalap, a RASP inhibitor in Phase 3 clinical testing for ocular inflammation.
Reproxalap is a novel, small-molecule immune-modulating covalent inhibitor of RASP (reactive aldehyde species), which are elevated in ocular and systemic inflammatory disease, and lead to activation of intracellular inflammatory factors, including NF-kB, inflammasomes, and Scavenger Receptor A. The mechanism of action of reproxalap has been validated with the demonstration of statistically significant and clinically relevant activity in multiple physiologically distinct late-phase clinical indications.
About Aldeyra Therapeutics
Aldeyra Therapeutics is a biotechnology company devoted to developing and commercializing next-generation medicines to improve the lives of patients with immune-mediated diseases. Aldeyra's lead investigational drug product candidates are potential first-in-class treatments in development for dry eye disease, allergic conjunctivitis, and proliferative vitreoretinopathy. The company is also developing other product candidates for retinal and systemic inflammatory diseases.
- 1 Cullen V, Mechanic J, Welihinda A, Young S, Amento E, Brady T. The small molecule aldehyde trap NS2 exhibits potent anti-inflammatory activity in 3 murine models of inflammation. Poster session presented at: American Academy of Allergy Asthma & Immunology 2015 Annual Meeting; 2015 Feb 20-24; Houston, TX.
2 Data on file.
3 Macdonald SG, Cullen V, Brady T, Beal D, Andreotta PW, Young SL. The Novel Aldehyde Trap, ADX-102, Reduces Inflammation-Mediated Lung Infiltrate in a Mouse Model of LPS-Induced Acute Lung Injury. Poster session presented at: World Congress on Inflammation 2017 Meeting; 2017 Jul 8-12; London, United Kingdom.
Source: Aldeyra Therapeutics, Inc.