CytoDyn Inc (OTCQB:CYDY) has announced encouraging early data from its long-hauler CD15 trial, which aimed to assess leronlimab administered as a weekly injection in people experiencing COVID-19 (coronavirus) symptoms for over 12 weeks.
"We are very pleased with the preliminary results from our long-haulers trial, which showed a greater improvement in the leronlimab patient group over placebo in 18 of 24 COVID-19 symptoms," said Chris Recknor, CytoDyn’s chief operating officer.
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"Although the study was not designed to show statistically significant differences due to the small sample size of 56 patients, clinically meaningful improvements in leronlimab over placebo were observed for cough, stuffy/runny nose, shortness of breath, tightness of chest, feeling of fast heartbeat, fatigue, muscle aches/cramps, muscle weakness, joint pain/swelling, chills/shivering, feeling hot or feverish, difficulty in concentration, sleep disturbance/insomnia, headache, dizziness, tingling/numbness, sense of taste, and sense of smell.
"Of the remaining six symptoms, sore throat, exertional malaise, anxiety, nausea, and vomiting had no clinically meaningful change.
"Diarrhea was worse in leronlimab-treated compared to placebo. Biomarkers at multiple time points are being analyzed to help determine reasons for response and to provide better insight into the mechanism of action of leronlimab. As in other previous trials with leronlimab, no adverse safety signals were noted. Once our final analysis is performed, we will seek to hold discussions with the FDA regarding next steps."
Nader Pourhassan, CytoDyn’s CEO, noted that before the trial had begun, the FDA had advised that the long-haulers trial was considered an exploratory trial, thus a follow-on trial would be necessary prior to potential approval.
"Our hope, following the FDA’s review of all data, is that the agency will grant us a Breakthrough Therapy designation and provide guidance for a Phase 3 trial protocol," he said.
CytoDyn is a late-stage biotech developing innovative treatments for multiple indications using leronlimab, a novel humanized monoclonal antibody targeting the CCR5 receptor.
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