Qualigen Receives Positive Pre-IND Response from FDA for COVID-19 Treatment

Qualigen Therapeutics announced receipt of written feedback to its Type B Pre-IND (Pre-Investigational New Drug application) meeting request from the U.S. Food and Drug Administration (FDA) that is in general agreement with the Company's planned clinical development of AS1411, a nucleolin-targeting DNA aptamer drug candidate, for the treatment of COVID-19.

The FDA's response solidifies Qualigen's intention to reprioritize its clinical development program and to first advance AS1411 into clinical trials (for treatment of COVID-19) in the first half of calendar 2021, to be followed next by seeking to advance ALAN into clinical trials against acute myeloid leukemia.  ALAN is AS1411 attached to a gold nanoparticle.

"We are delighted with the FDA's thoughtful and thorough response to our Pre-IND meeting request which provides a pathway for us to move forward with filing the IND application and initiation of a clinical trial in the first half of calendar 2021," said Michael Poirier, President, Chief Executive Officer and Chairman of Qualigen. "We are in agreement with the FDA's additional recommendations and believe their responses provided the clarity needed to move forward to get AS1411 into clinical trials for the treatment of hospitalized patients with COVID-19. In addition, we look forward to further investigating the potential use of AS1411 as a broader spectrum antiviral therapeutic."

In its Pre-IND meeting request, the Company requested regulatory guidance on its planned randomized, multicenter study to evaluate the safety and efficacy of AS1411 in hospitalized patients with COVID-19.  The FDA's recommendation is to commence with a Phase 2a proof-of-concept study to evaluate safety and initial efficacy in determining the appropriate dose with outcomes assessed at Day 28. The Company and the FDA agree that a Phase 1 clinical trial is not needed here, because in a previous clinical trial against cancer AS1411 has already been shown to meet Phase 1 safety requirements.

"There continues to be a need for novel treatments for COVID-19," said Paula Bates, PhD, Professor of Medicine at the University of Louisville, who co-invented the technology. "We know that nucleolin plays an important role in the infectivity of viruses and were able to demonstrate in our AS1411 preclinical studies, the aptamer was effective against the SARS-CoV-2 virus at doses indicated to be safe in humans by previous research. As a result, we believe AS1411 has the potential to be a promising therapeutic for COVID-19, as well as for other viral infections."

Preclinical research conducted at the University of Louisville has demonstrated that AS1411 has potent anti-viral activity against SARS-CoV-2 infection, the novel coronavirus responsible for COVID-19. Qualigen has held an exclusive license to AS1411 since 2018, and in June 2020 Qualigen entered into an exclusive license agreement for the University of Louisville's pending U.S. patent for the use of AS1411 for inhibiting or treating COVID-19.