CytoDyn sends leronlimab coronavirus trial results to FDA, seeks emergency approval

CytoDyn Inc (OYCQB:CYDY) has provided the topline report from its recent Phase 2 trial of leronlimab in mild-to-moderate coronavirus patients to the US Food and Drug Administration and requested emergency use approval, the company announced Monday.  The company has also sent the report to regulatory authorities in Mexico, the UK, the Philippines and the European Union. The trial utilized the National Early Warning Score (NEWS), a scale developed by the Royal College of Physicians to identify patients at risk for rapid clinical deterioration requiring critical care. NEWS2, the latest version, measures clinical parameters including respiratory rate, oxygen saturation, supplemental oxygen, temperature, systolic blood pressure, heart rate, and level of consciousness. READ: CytoDyn's leronlimab delivers health improvements for coronavirus patients in Phase 2 trial Patients in the leronlimab group were more than twice as likely to experience an improvement in NEWS2 scores than the placebo group after two weeks. Half of leronlimab patients improved by that metric, compared to 20% of placebo patients. Safety-wise, the incidence, frequency and severity of adverse events (AEs) and serious adverse events (SAEs) were lower in the leronlimab group than the placebo group. “We are very motivated to provide leronlimab to patients throughout the world who are suffering from COVID-19,” Cytodyn CEO Nader Pourhassan said in a statement. “We believe the statistically significant data of NEWS2 findings, along with impressive safety results (less SAEs or AEs with leronlimab vs. placebo), from our Phase 2 trial set forth in the topline report provides compelling data in support of leronlimab’s use to fight COVID-19.” In addition to its mild-to-moderate trial, CytoDyn said it has been approached by doctors about a clinical study of leronlimab in patients referred to as COVID-19 “long-haulers,” whose symptoms can last for months. The company is preparing a Phase 3 protocol and plans to file it as soon as possible. “We are in discussions with several regulatory agencies in other countries and hope to obtain emergency approval for its use,” Pourhassan said. “We are in a very exciting period for CytoDyn in regards to the potential role of leronlimab in three different COVID-19 populations: mild-to-moderate, severe-to-critical, and long-haulers.”     Contact Andrew Kessel at andrew.kessel@proactiveinvestors.com Follow him on Twitter @andrew_kessel