CytoDyn Inc (OTCQB:CYDY) announced Tuesday that its drug leronlimab showed early clinical improvement in mild-to-moderate coronavirus patients in a recently completed Phase 2 trial.
In patients with a Total Clinical Symptom Score of 4 or more, with higher scores indicating a worse health state, leronlimab led to a greater improvement after three days (90% of patient scores improved) than the placebo (71% of scores improved).
"We initiated the study hoping to reduce flu-like symptoms, such as fever, cough, and muscle aches,” Senior Science Advisor Jacob Lalezari said in a statement. “In the end, use of leronlimab was not only correlated with improved symptom scores in patients with measurable symptoms at baseline, but also provided significant and consequential benefits on far more serious endpoints. Demonstrating these efficacy signals in a population with mostly mild illness at study entry bodes well for leronlimab’s activity in patients with more severe illness.”
The study also 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.
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.
“We are thrilled with the results of leronlimab in mild-to-moderate COVID-19 patients,” Chief Medical Officer Scott Kelly said. “It is paramount to determine which patients will deteriorate and require critical care interventions, including patients at risk for ICU admission, cardiac arrest, or death within 24 hours... We are pleased that leronlimab showed a statistically significant result in a randomized, double-blinded study for NEWS2.”
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. Patients treated with placebo were more than twice as likely to experience SAEs or AEs compared to patients treated with leronlimab, the company said.
“The decreased probability in serious adverse events, as well as overall adverse events with leronlimab compared to placebo further supports the use of leronlimab as a treatment option for COVID-19,” Kelly added.
Going forward, CytoDyn will report the results to the US Food and Drug Administration (FDA), the UK Medicines & Healthcare products Regulatory Agency (MHRA) and the EU European Medicines Agency.
“In the mild- to-moderate population, it is important to have a therapeutic option for COVID-19 in patients who are showing signs of rapid clinical deterioration,” CEO Nader Pourhassan said. “Patients receiving leronlimab showed a statistically significant improvement using NEWS2 clinical parameters. We will make a case for immediate approval of leronlimab for this population of COVID-19 patients, not only in the US, but in the UK and other countries around the world.”
Contact Andrew Kessel at [email protected]
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