Business
Aldeyra Therapeutics to Advance ADX-1612, an Investigational New HSP90 Inhibitor with Potential Nanomolar Potency Against SARS-CoV-2, to Clinical Testing for COVID-19; ADX-629 Accepted for BARDA CoronaWatch Meeting
ADX-1612 Demonstrates Nanomolar SARS-CoV-2 Antiviral Potency In Vitro Pending FDA Feedback, IND Submission for ADX-1612 Expected in Third Quarter 2020 IND
About this update from Aldeyra Therapeutics, Inc.
[{"type":"text","content":"\n\nADX-1612 Demonstrates Nanomolar SARS-CoV-2 Antiviral Potency In Vitro\n\n\nPending FDA Feedback, IND Submission for ADX-1612 Expected in Third Quarter 2020\n\n\nIND Submission for ADX-629 Expected in June 2020\n\n\nManagement to Host Conference Call at 8:00 a.m. ET Today\n\n\n LEXINGTON, Mass.--(BUSINESS WIRE)--\nAldeyra 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 announced the planned advancement of the investigational new HSP90 inhibitor ADX-1612 to clinical testing for COVID-19, and provided an update on ADX-629, a novel investigational RASP inhibitor in development for COVID-19 and other inflammatory diseases.\n\n\nADX-1612, which has been clinically tested in more than 1,600 subjects for the potential treatment of cancer, is an inhibitor of chaperone protein HSP90, a target widely implicated in viral disease.1 Aldeyra announced that ADX-1612 has demonstrated nanomolar potency similar to or greater than that of remdesivir in an in vitro model. Complementary to the nucleic acid inhibition mechanism of action of remdesivir and related antiviral compounds, ADX-1612 potentially leads to the inhibition of proteins associated with viral replication and infection, and thereby may enhance the activity of other antiviral drugs for the treatment of COVID-19. Importantly, via comprehensive expression profiling of human cell lines infected with SARS-CoV-2, HSP90 was recently identified as a key pharmaceutical target for viral inhibition.2 Pending FDA feedback, an Investigational New Drug (IND) submission for ADX-1612 is expected in the third quarter of 2020.\n\n\nAldeyra also announced that ADX-629, a novel orally administered investigational RASP inhibitor, has been granted a BARDA CoronaWatch meeting. ADX-629 has completed pre-IND discussions with the Pulmonary Division of the U.S. Food & Drug Administration, and Aldeyra expects to submit an IND application in June 2020. Severe COVID-19 is characterized by cytokine release syndrome, which may lead to respiratory compromise, often including the requirement for mechanical ventilation. In a preclinical model of cytokine storm, ADX-629 has demonstrated broad-based reductions across a variety of TH1, TH2, and TH17...