Qualigen Therapeutics has completed the recertification of its supply of AS1411, and has begun final formulation and filling for use in the Company's proposed Phase 2a efficacy trials of AS1411 for the treatment of patients with COVID-19. Qualigen plans to seek U.S. Food and Drug Administration (FDA) approval for and to begin these trials in the first half of calendar 2021.
Qualigen's lead compound AS1411 is a nucleolin-targeting DNA aptamer drug candidate for the treatment of COVID-19 and other viruses. Preclinical studies at the University of Louisville's (UofL) Center for Infectious Disease have demonstrated the ability of AS1411 to protect cells from the damaging effects of the novel coronavirus. In addition, AS1411 holds potential as a broad antiviral therapeutic agent, which could expand its applications and market potential.
"Even with the roll-out of COVID-19 vaccines, we see this virus being around for many years to come in different forms. The mechanism by which AS1411 is believed to work, by blocking the ability of viruses to replicate in the body, may make our therapeutic effective against future mutations in COVID-19 as well as against other dangerous viruses including the flu," said Michael Poirier, President, Chief Executive Officer and Chairman of Qualigen.
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"Recertification of our AS1411 inventory represents another critical step in advancing our antiviral development program in a cost-efficient manner. We continue to move forward with our IND-enabling studies and are on track to commence the efficacy stage of human trials in the first half of next year, upon obtaining IND approval from the FDA. We believe there is great potential for this drug to be an effective therapeutic for COVID-19, in addition to other viral infections," Poirier said.
In June 2020, Qualigen signed an exclusive license agreement with UofL for U.S. patent rights covering the treatment of COVID-19 with AS1411, adding to Qualigen's other AS1411 license exclusivities. Qualigen intends to work with UofL to complete investigational new drug (IND)-enabling studies and plans to file an IND application with the FDA in early calendar 2021. Qualigen's aim is to initiate a Phase 2a clinical study in COVID-19 patients in the first half of calendar 2021.