CytoDyn Inc (OTCQB:CYDY), a biotechnology company developing leronlimab (PRO 140) for multiple indications, revealed on Tuesday that the UK government’s Medicines and Healthcare products Regulatory Agency (MHRA) has cleared CytoDyn to file its Biologics License Application (BLA) for leronlimab as a combination therapy for multi-drug resistance HIV patients in the UK.
Vancouver, Washington-based CytoDyn said that the MHRA’s greenlight for the BLA filing included a treatment regimen of one injection per week of 350 mg of leronlimab, as contrasted to the dosage used in the Phase 3 clinical trial conducted in the US for this indication of two consecutive injections of 175 mg per week.
CytoDyn noted that during a recent two-hour-long meeting between its BLA team and the MHRA, they discussed in detail the primary components of the 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.
In a statement, CytoDyn CEO Nader Pourhassan said: “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.”
He added: “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 US and abroad.”
Dr Pourhassan noted that should CytoDyn receive approval in the UK for leronlimab as a HIV combination therapy, the firm will “follow up immediately with a label expansion of monotherapy in UK.”
The company continues to focus its energies on enrolling more patients in its severe-to-critical COVID-19 Phase 3 trial. Dr Pourhassan said that in addition to moving “forward rapidly” to complete the BLA for HIV, in multiple countries, the company plans to file a protocol and IND for Phase 2 clinical trials for leronilimab for both stroke and coronavirus “long haulers” who suffer symptoms months later.
Meanwhile, the US Food and Drug Administration has granted Fast Track designation to CytoDyn for a combination therapy with HAART for HIV-infected patients and metastatic triple-negative breast cancer.
Contact the author Uttara Choudhury at [email protected]
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