CytoDyn reports interim data from HIV leronlimab monotherapy trial

CytoDyn (OTCQB:CYDY) reported interim data from its dose-escalating trial of leronlimab monotherapy for the treatment of HIV.

Leronlimab is humanized monoclonal antibody that targets CCR5, a receptor by which HIV enters immune cells.

In the trial, 229, 201, and 134 HIV patients received 350 mg, 525 mg, or 700 mg of leronlimab once a week, respectively. Approximately 150 patients showed sustained viral suppression at one year.

The rate of viral load suppression post-10 weeks of monotherapy was 68%, 94%, and 85% with the 350 mg, 525 mg, and 700 mg doses, respectively.

“These results position us well for our upcoming face-to-face meeting with the FDA regarding our pivotal monotherapy trial protocol,” Nader Pourhassan, CytoDyn’s president and CEO, said in a statement.

“Even more impressive is the long-term durability of the antiviral response in some patients in our other trials, with six patients reaching three years successfully on monotherapy and another four patients nearing the five-year mark for suppressed viral load,” he added.

Leronlimab for HIV has been granted fast track designation and a rolling review process by the FDA.

Sign up for the BioTuesdays weekly newsletter

Get the latest news on the healthcare industry’s corporate and clinical developments, executive moves, and market updates. Every Tuesday, in your inbox.