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CytoDyn's Leronlimab Gets Philippines FDA Approval To Treat A COVID-19 Patient; Seeks EUA

CytoDyn Inc. (CYDY.OB), the developer of Vyrologix (leronlimab -PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced Monday that the Republic of the Philippines, Department of Health, Food and Drug Administration has approved the use of leronlimab to treat a COVID-19 patient.

The use of leronlimab for the patient was under Compassionate Special Permit or CSP pursuant to FDA Order No. 2016-005. CytoDyn said it is simultaneously pursuing EUA in the Philippines for leronlimab as a treatment in an effort to reduce COVID-19 mortality while expanding its access under CSP.

CytoDyn is shipping leronlimab to its partner, Chiral Pharma Corp., its importer in the Philippines.

Francis Gomez, President of Chiral Pharma said the companies will also seek CSP approval for leronlimab for COVID-19 long-hauler patients in the Philippines.

Leronlimab is an investigational humanized IgG4 mAb that blocks CCR5, a cellular receptor important in HIV infection, tumor metastases, and other diseases, including NASH.

The FDA has granted a Fast Track designation to CytoDyn for two potential indications of leronlimab for critical illnesses. The first indication is combination therapy with HAART for HIV-infected patients, and the second is for metastatic triple-negative breast cancer.

Leronlimab has completed 11 clinical trials in over 1,200 people and met its primary endpoints in a pivotal Phase 3 trial.

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