Experimental coronavirus treatment leronlimab shows 'very promising' response in some COVID-19 patients

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The experimental coronavirus treatment leronlimab has shown a “very promising” response in COVID-19 patients with mild-to-moderate symptoms, according to developer CytoDyn.

Leronlimab is a viral-entry inhibitor that targets HIV and breast cancer. The drug has also been attracting attention as a potential coronavirus treatment. In a statement released Monday CytoDyn gave an update on over 30 patients COVID-19 patients recently treated with leronlimab in more than 4 hospitals and clinics across the U.S.  Patients have received leronlimab as part of Emergency Investigational New Drug (EINDs) treatments authorized by the FDA and two CytoDyn clinical trials.

“More than 25 patients have been administered leronlimab under EINDs authorized by the U.S. Food and Drug Administration (FDA),” the biotech explained. “Rate of response in mild-to-moderate patients under EIND has been very promising with the first five patients treated being removed from oxygen.”

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Leronlimab is one of a number of drugs in the spotlight as the world scrambles to contain the coronavirus pandemic. Experts, however, have warned that people should not take drugs unless prescribed by a doctor.

CytoDyn CEO Nader Pourhassan said that the company is working to ramp up its research into leronlimab as a potential coronavirus treatment. “We continue to coordinate around the clock with healthcare professionals across the country to deliver leronlimab to patients and we are in regular contact with the FDA to ensure they receive current patient data,” he said, in the statement. “We are planning to rapidly enroll 75 patients and report the results to the FDA as quickly as possible.”

The Vancouver, Washington-based company said that, as of last week, 12 patients have been treated in a Phase 2 trial for mild-to-moderate COVID-19 indications. However, results are not yet available.  The first site cleared to enroll patients in a Phase 2b/3 trial starts Monday, according to the biotech.

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More than 25 hospitals have requested to participate in the company’s trials.

The FDA had already granted CytoDyn a “fast-track” designation for two potential uses of leronlimab – as a combination therapy with other medications for HIV patients and for patients with metastatic triple-negative breast cancer. Leronlimab blocks CCR5 (C-C motif chemokine receptor 5), a cellular receptor important in HIV infection, tumor metastases, and other diseases, according to CytoDyn. “Leronlimab has completed nine clinical trials in over 800 people, including meeting its primary endpoints in a pivotal Phase 3 trial (leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients),” explained CytoDyn, in the statement.

Separately, the experimental COVID-19 treatment remdesivir is showing early promise in the battle against the coronavirus outbreak, according to a small research study.

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The study, which was recently published in the New England Journal of Medicine, was supported by remdesivir developer Gilead Sciences.

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As of Monday morning, at least 1.86 million coronavirus cases have been diagnosed worldwide, at least 557,663 of which are in the U.S. The disease has accounted for at least 115,286 deaths around the world, including more than 22,000 people in the U.S.

Follow James Rogers on Twitter @jamesjrogers