KBio has announced that the FDA has cleared its investigational new drug application for EV68-228-N, a human monoclonal IgG1 antibody targeting enterovirus D68 capsid. This antibody is intended for intravenous treatment of acute flaccid myelitis (AFM), a rare neurological condition causing muscle weakness and paralysis without approved specific treatments.

Manufactured using KBio's Rapid Protein Production Platform (RP3) based on Nicotiana benthamiana, EV68-228-N underwent FDA review alongside KBio's Drug Master File (DMF) for the IND submission. The Phase 1 study, at Vanderbilt University Medical Center (VUMC), assesses safety and pharmacokinetics of single ascending doses of EV68-228-N in healthy adults. This placebo-controlled, double-blinded trial involves 36 participants aged 18 to 49, with six receiving placebo and thirty receiving varying EV68-228-N doses.

Dr. Matthew Vogt's EV68-228-N discovery, initially at Vanderbilt University Medical Center, underscores collaboration with Dr. C. Buddy Creech, principal investigator from the Vanderbilt Vaccine Research Program, and partnerships with KBio and ZabBio. KBio CEO Patrick Doyle highlighted FDA EV68-228-N clearance, emphasizing potential AFM patient impact via innovative, cost-effective biologic production.

National Institute of Allergy and Infectious Diseases (NIAID) and conducted via the Infectious Diseases Clinical Research Consortium (IDCRC), this study advances monoclonal antibody therapies for AFM and other infectious diseases. KBio's RP3 platform offers rapid scalability and production, addressing unmet medical needs in various therapeutic areas.

 

Source: globenewswire.com

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