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.
NeoImmuneTech names new president and chief executive officer
BenevolentAI reports positive Phase Ia safety and pharmacokinetic data for BEN-8744
Thermo Fisher Scientific unveils CorEvitas registry for generalized pustular psoriasis
Nektar Therapeutics commences Phase 2b rezpegaldesleukin clinical trial for alopecia areata
Innovent Biologics doses first participant in first-in-human phase one clinical trial of IBI3002
Ananda Developments secures CBD Drug Supply Agreement for endometriosis clinical trial
Trellus Health secures agreement with major US health plan for IBD management
argenx receives FDA priority review for VYVGART Hytrulo in CIDP
AffaMed Therapeutics' DEXTENZA NDA accepted by Singapore regulator
AbbVie showcases gastroenterology portfolio at ECCO Congress
Japan approves Sanofi's Dupixent for chronic spontaneous urticaria
Ono partners with Shattuck Labs for bifunctional fusion proteins