On July 7, CytoDyn Inc. (OTC.QB: CYDY), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with potential clinical indications for HIV, COVID-19, cancer, GvHD (graft versus host disease), and NASH (non-alcoholic steato-hepatitis), announced the results from a preclinical macaque study evaluating leronlimab as pre-exposure prophylaxis (PrEP) to prevent sexual HIV transmission. The study evaluated the impact of a macaque-equivalent dose of either 350 mg (once weekly) or 700 mg (bi-monthly) leronlimab on acquisition of infection in a total of 18 animals, and found that the equivalent 700 mg bi-monthly leronlimab dose completely prevented rectal transmission of Simian-Human Immunodeficiency Virus (SHIV) in macaques. These results were presented today in an oral presentation titled “CCR5 Antibody Blockade Protects Rhesus Macaques from Rectal SHIV Acquisition" at the 23rd International AIDS Conference (AIDS 2020) (https://www.aids2020.org/). “The results reported here in the preclinical macaque model of HIV sexual transmission support leronlimab as a possible PrEP (pre-exposure prophylaxis) agent at a time when long-acting human HIV PrEP options are limited,” said Jonah Sacha, PhD, Professor at Oregon Health & Science University (OHSU), and the study’s lead investigator. “We are eager to build upon these preclinical results describing leronlimab’s utility in HIV prevention by initiating clinical studies for leronlimab as a PrEP treatment. Current PrEP options require a continued daily dosing regimen in order to be effective and are inherently difficult to maintain in the long-term,” said Nader Pourhassan, PhD, President and Chief Executive Officer of CytoDyn, which has developed leronlimab.
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