CytoDyn Inc (OTCQB:CYDY) announced Monday that the company has enrolled and begun treating the first two patients in its Phase 2 trial of leronlimab for people with mild-to-moderate coronavirus symptoms.
The company expects enrollment to accelerate this week at multiple clinical sites.
Separately, 15 severely ill coronavius patients have been treated with leronlimab so far, primarily in New York, under an emergency investigational new drug designation granted by the US Food and Drug Administration for each individual patient.
READ: CytoDyn says coronavirus patients treated with leronlimab show initial improvements after three days
Initial results from the first four such patients after a week of treatment are “very promising,” the company said, and results from the first 10 patients will be available this week.
“We are encouraged by the positive results demonstrated with leronlimab in the New York patients,” said Bruce Patterson, the CEO of CytoDyn’s diagnostic partner and advisor IncellDX in a statement.
“Our team is working hard to distribute leronlimab to multiple clinical sites to initiate therapy in patients with severe COVID-19 disease. While every patient is experiencing different comorbidities, we are seeing similar clinical responses, which we believe is a reflection of leronlimab’s mechanism of action.”
A second clinical trial
CytoDyn expects to kick off an additional Phase 2 trial this week, this one for severely ill coronavirus patients. The second study is for 342 patients and will be double-blinded with a 2:1 drug to placebo ratio.
Patients are expected to be given leronlimab for two weeks, and the primary endpoint of the study is the mortality rate after that period. An interim analysis will be conducted after the first 50 patients.
“Our partnership with the New York medical team and now other hospitals has been exemplary,” CEO Nader Pourhassan said. “We are collaborating in every aspect to deliver leronlimab to patients in order to provide proof of concept as soon as possible.
“The outstanding coordination among the physicians, the hospital administrators, the FDA, and our team, will hopefully help mitigate the deleterious effects from this pandemic should we prove leronlimab as a solution. The lead physician in New York is a true medical hero, who deserves to be recognized for his contribution to humanity in the pandemic of COVID-19.”
In addition to its use as a potential coronavirus treatment, leronlimab has other therapeutic indications as a treatment for HIV and certain breast cancers.
Contact Andrew Kessel at [email protected]
Follow him on Twitter @andrew_kessel