CytoDyn Inc (OTCQB:CYDY), which is developing its flagship drug leronlimab (PRO 140) to battle multiple diseases, said on Tuesday that it has appointed Chiral Pharma, a subsidiary of Philippine New Marketlink Pharmaceutical Corporation (NMPC), to register leronlimab for potential approval from the health regulator in the Philippines to treat coronavirus (COVID-19) patients.
In a statement, CytoDyn CEO Nader Pourhassan said the company was committed to “making leronlimab available in the Philippines.”
Vancouver, Washington-based CytoDyn completed its Phase 2 trial to evaluate the effectiveness and safety of leronlimab in patients with mild-to-moderate COVID-19 in July this year. Patients receiving leronlimab experienced 64% fewer serious adverse events (SAEs) during the trial than patients receiving placebo. The Phase 2 clinical trial for mild-to-moderate patients in the US produced statistically significant results on the National Early Warning Score 2 scale (NEWS2).
READ: CytoDyn to meet with UK regulators to discuss Fast-Track approval for leronlimab, schedules sitdown with FDA
CytoDyn has also enrolled the requisite number of patients for a Phase 3 randomized clinical trial for severe-to-critically ill COVID-19 patients in hospitals in the US. An interim analysis on the first 195 patients will be shared by mid-October.
The US Food & Drug Administration (FDA) has granted Fast Track designation to CytoDyn for two potential indications of leronlimab for critical illnesses. The first as a combination therapy with HAART for HIV-infected patients and the second is for metastatic triple-negative breast cancer.
Contact the author Uttara Choudhury at [email protected]
Follow her on Twitter: @UttaraProactive