The feedback from the FDA came in response to Qualigen's preinvestigational new drug (IND) application meeting request. In the application, Qualigen asked the FDA for guidance on its planned randomized multicenter trial of AS1411, a nucleolin-targeting DNA aptamer drug candidate, for the treatment of COVID-19.

The FDA's feedback on Qualigen's plan was "thoughtful and thorough," according to the company. Qualigen said the FDA gave the company a pathway to follow in order to file an IND application and initiate a clinical trial.

The FDA advised Qualigen start its investigation with a phase II proof-of-concept study with outcomes assessed at day 28 in order to determine the appropriate dose of ASA1411 for future research. In addition, the agency said a phase I trial wasn't needed because the candidate had already met safety requirements in a previous clinical trial investigating its use as a cancer therapy.

The FDA's response aligns with Qualigen's current plan to begin a clinical trial of AS1411 in patients hospitalized with COVID-19 in the first half of 2021. The company plans to follow this trial with one investigating ALAN, a version of AS1411 combined with a gold nanoparticle.

AS1411 is a DNA-coated gold nanoparticle that targets and binds nucleolin, a protein that plays a role in how viruses attack and utilize cells for replication. Preclinical studies, conducted at University of Louisville Center for Infectious Disease, showed that AS1411 protected cells from the damaging effects of SARS-CoV-2 by binding nucleolin.

Qualigen has held an exclusive license for the candidate since 2018. It has also entered into an exclusive license agreement with the University of Louisville for a U.S. patent on its use for COVID-19 therapies.