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.
Blacksmith Medicines granted US patent for antibacterial compounds targeting LpxC
Seegene launches STAgora infectious disease analytics platform
Alvotech and Advanz Pharma sign European deal for Cimzia biosimilar
Amgen's Phase 3 bemarituzumab plus chemotherapy clinical trial meets primary endpoint
TuHURA Biosciences acquires Kineta
Tyra Biosciences doses first patient in TYRA-300 Phase 2 study for bladder cancer
hVIVO supports Cidara Therapeutics' positive Phase 2b influenza study results
Sanofi's riliprubart receives orphan drug designation in Japan for CIDP
HUTCHMED gains China approval for ORPATHYS and TAGRISSO combination in lung cancer
Mabwell and Qilu Pharmaceutical enter licence agreement for Albipagrastim alfa for Injection
FDA approval streamlines access to Bristol Myers Squibb CAR T cell therapies