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CytoDyn Receives the UK's MHRA Approval for Phase 3 COVID-19 Study

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CytoDyn Inc. shares traded higher after the company reported it received authorization from the U.K.'s MHRA to proceed with its Phase 3 study of leronlimab in patients with severe-to-critical COVID-19.

Late-stage biotechnology company CytoDyn Inc. (CYDY:OTCQB), which is focused on the development of a CCR5 antagonist, leronlimab (PRO 140), for multiple potential therapeutic indications, announced late last week that the "Clinical Trials Unit of the Medicines & Healthcare product Regulatory Agency (MHRA) of the U.K. government authorized the company to enroll for its ongoing Phase 3 COVID-19 trial for severe-to-critical patients in the U.K." The firm noted that the decision by the MHRA followed many months of review of its manufacturing processes and the safety profile of leronlimab.

The company's President and CEO Nader Pourhassan, Ph.D., commented, "We are very pleased with the MHRA's confidence in leronlimab to initiate enrollment of patients in the U.K. for our current CD12 protocol. CytoDyn recently requested 'fast track approval' from the MHRA for its completed Phase 2 COVID-19 trial for the mild-to-moderate population, with strong efficacy and safety data. We believe leronlimab has multiple opportunities for several clinical indications and we are very optimistic about our future based upon how far we have advanced this drug in about 5 years. In addition, we plan to file a Biologics License Application (BLA) for HIV in the U.K. within the next 4 weeks."

The firm indicated that it completed its randomized Phase 2 clinical trial (CD10) for COVID-19 for mild-to-moderate patients in the U.S. and that enrollment is continuing in its ongoing Phase 3 study for severe-to-critically ill COVID-19 patients in several U.S. hospitals.

The company explained that "leronlimab (PRO 140) is an investigational humanized IgG4 mAb that blocks CCR5, a cellular receptor that is important in HIV infection, tumor metastases, and other diseases, including NASH." The firm noted that it has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for two potential indications of leronlimab for critical illnesses. The first of these approvals is as a part of a combination therapy with HAART for HIV-infected patients and the second is for metastatic triple-negative breast cancer.

CytoDyn stated that leronlimab has completed nine clinical studies in over 800 individuals and met its primary endpoints in a pivotal Phase 3 trial combination therapy trial in HIV patients. In addition, the company is presently conducting a Phase 1b/2 human clinical trial in metastatic triple-negative breast cancer.

CytoDyn has a market capitalization of around $1.9 billion with approximately 568.2 million shares outstanding. CYDY shares opened 16% higher today at $3.99 (+$0.56, +16.33%) over Friday's $3.43 closing price. The stock has traded today between $3.61 to $4.02 per share and is currently trading at $3.72 (+$0.29, +8.45%).


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