U.K. MHRA Clears CytoDyn to File its BLA for Leronlimab as One Injection per Week for Combination HIV Therapy
VANCOUVER, Washington, Oct. 26, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (“CytoDyn” or the “Company"), a late-stage biotechnology company developing leronlimab (PRO
140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced today the Medicines & Healthcare product Regulatory Agency (MHRA) of the U.K. government has cleared
CytoDyn to file its Biologics License Application (BLA) for leronlimab as a combination therapy for multi-drug resistance HIV patients in the U.K.
The MHRA’s clearance for the BLA filing included a treatment regimen of one injection per week of 350 mg of the Company’s product leronlimab, as contrasted to the dosage used in the Phase 3 clinical trial conducted in the U.S. for this indication of two consecutive injections of 175 mg per week. During a recent 2-hour meeting between the CytoDyn BLA team and the MHRA, the parties discussed in detail the primary components of the BLA filing: non-clinical, clinical and manufacturing. In connection with the manufacturing section, the Company confirmed it had the necessary one-year of stability data for a 350 mg dose of leronlimab for patients in need of this treatment.
Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn, commented, “We are very pleased with the MHRA’s decision to clear our BLA for filing and our team is finalizing the remaining details to ensure a complete filing very soon. We hope to receive notice of acceptance within two weeks of our filing. The MHRA also had questions about CytoDyn’s recent COVID-19 Phase 3 severe-to-critical population interim analysis. We are very excited with all of the opportunities we are able to explore for leronlimab’s potential indication in the U.S. and abroad. Should CytoDyn receive approval in the U.K. for HIV combination therapy, we will follow up immediately with a label expansion of monotherapy in U.K.”
About Leronlimab’s Ability to Cross Blood-Brain Barrier
The blood-brain barrier (BBB) mediates the communication between the periphery and the central nervous system (CNS). The BBB separates the circulation from the brain. It is a highly selective permeable border of endothelial cells and acts as a metabolic barrier, transport interface, and secretory body. The BBB prevents solutes in the circulating blood from non-selectively crossing into the central nervous system's extracellular fluid where neurons reside. The blood vessels that vascularize the central nervous system (CNS) possess unique functions. The BBB allows precise control of CNS homeostasis. It serves to allow for proper neuronal function and also protects the neural tissue from toxins and pathogens. Alterations of these barrier properties are an important component of central nervous system diseases.