Cytocom announced the successful completion of a Type B pre-IND meeting with the U.S. Food and Drug Administration (FDA) in relation to the Company's planned Phase 2 clinical trial of CYTO-201 for the treatment of SARS-CoV-2, the virus responsible for COVID-19. Based on the FDA's feedback, Cytocom plans to revise the study protocol and quickly initiate enrollment.

Cytocom has proposed a randomized, Phase 2 study to evaluate the safety and efficacy of CYTO-201 as a treatment to slow or halt the progression of the SARS-CoV-2 infection from mild/moderate (stage 1-2A) to severe (stage 2B-3).

The FDA provided guidance on Cytocom's plans for the proposed Phase 2 trial, as well as expedited review paths and 505(b)(2) premarketing requirements for CYTO-201. Cytocom provided the agency with data from preclinical in vitro studies that demonstrated the potential of CYTO-201 to inhibit the replication of the SARS-CoV-2 virus in human lung cells. Further, Cytocom has demonstrated in previous human studies that CYTO-201 can dampen harmful inflammation and possibly promote protection from reinfection. These are particularly important features in the fight to tamp down the spread of COVID-19.

"Our positive interactions with the FDA, combined with the expedited regulatory process, places CYTO-201 on an accelerated positive NDA submission path. This represents a significant milestone for Cytocom and patients suffering from the debilitating and life threatening consequences that stem from COVID-19," Michael Handley, Cytocom CEO, said.