CytoDyn sends leronlimab coronavirus trial results to FDA, offers update on HIV treatment progress

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.” Leronlimab for HIV CytoDyn also provided investors with an update on the progress of its HIV programs. “We now have four paths forward for use of leronlimab in the HIV indication for different populations,” Pourhassan said in a separate statement. “The first path is a combination therapy where we successfully completed a Phase 3 trial with statistically significant p value for our primary endpoint. CytoDyn is awaiting a Type A meeting with the FDA for this treatment.” Additionally, the company said that of the 49 HIV patients who stopped their HIV medications and used leronlimab as a monotherapy, 25 have been in monotherapy trials for two to four years and five patients have been involved for nearly or over six years. Monotherapy was successful for some of these patients by switching from 350 mg to a higher dose of 525 mg or 700 mg, the company added.  CytoDyn plans to submit manuscripts for two publications in regards to its findings. “Second is our monotherapy; we will discuss the potential approval path for label expansion at the time of our Type A meeting,” Pourhassan said. “Third is our PrEP study to examine the use of leronlimab for once-a-month self-injection for HIV prevention. Our fourth path is an HIV-Cure, where 5 patients will be put to test to duplicate the Berlin and London patients’ HIV functional cure.” The company also believes that leronlimab could be a once-a-month self-injectable, subcutaneous HIV PrEP treatment. At the AIDS 2020 Virtual Conference, a macaque model of HIV sexual transmission showed that leronlimab can prevent transmission by blocking HIV’s access to the CCR5 co-receptor. CytoDyn is in discussions with potential organizations to fund its next trial in HIV PrEP. Additionally, the company said that of the 49 HIV patients who stopped their HIV medications and used leronlimab as a monotherapy, 25 have been in monotherapy trials for two to four years and five patients have been involved for nearly or over six years. Monotherapy was successful for some of these patients by switching from 350 mg to a higher dose of 525 mg or 700 mg, the company added.  CytoDyn plans to submit manuscripts for two publications in regards to its findings. “Second is our monotherapy; we will discuss the potential approval path for label expansion at the time of our Type A meeting. Third is our PrEP study to examine the use of leronlimab for once-a-month self-injection for HIV prevention. Our fourth path is an HIV-Cure, where 5 patients will be put to test to duplicate the Berlin and London patients’ HIV functional cure,” the group said. The company believes that leronlimab, which blocks the protein CCR5 on the surface of white blood cells, can be utilized as part of a cure for HIV.  CCR5 has proven to be a key molecule in mediating HIV remission, and the only two patients to be functionally cured of HIV received allogeneic stem cell transplants from CCR5-deficient donors. The company thinks that leronlimab could be used in the setting of allogeneic stem cell transplantation to functionally convert a stem cell graft from a wildtype CCR5 stem cell donor into one from a CCR5 deficient donor, and thereby functionally cure the recipient of HIV. CytoDyn plans to test this theory in a pilot clinical trial of five HIV patients with cancer who require bone marrow transplantation. Leronlimab will be used during the peri-transplant period to mimic a CCR5 deficient donor in order to achieve HIV cure. Contact Andrew Kessel at andrew.kessel@proactiveinvestors.com Follow him on Twitter @andrew_kessel