Policy & Regulation
Cytocom Completes Type-B Pre-IND Meeting with FDA Regarding Proposed Phase 2 Clinical Trial of CYTO-201 in COVID-19 Patients
29 June 2020 - - US-based biopharmaceutical company Cytocom, Inc has completed a Type B pre-IND meeting with the US Food and Drug Administration 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 randomised, 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.

Cytocom is a clinical-stage biopharmaceutical company developing novel immunotherapies targeting autoimmune, inflammatory, infectious diseases and cancers based on a proprietary platform that is designed to rebalance body's immune system.


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