CytoDyn has enrolled and dosed 20 subjects in the first ten days of its Phase II trial of Vyrologix (leronlimab-PRO 140) in patients with Covid-19 long-haulers symptoms.
A CCR5 antagonist, leronlimab possesses the potential for various therapeutic indications.
The randomised, double-blind, placebo-controlled study will analyse the efficacy and safety of leronlimab in participants with prolonged Covid-19 symptoms called long-haulers.
CytoDyn intends to enrol 50 patients in the trial. Each subject will be given eight weekly doses of leronlimab and followed up for four weeks of safety evaluation.
The endpoint measure will be at day 56, while the trial results are anticipated by June this year.
CytoDyn Clinical Development vice-president Christopher Recknor said: “This trial represents a potential solution for many patients with post-acute sequalae from Covid-19 (PASC) known as long-haulers where currently no treatment is available.
“Patients in the trial have had lingering symptoms for over 12 weeks and they need help. We are looking at sophisticated biomarkers that will help us identify who benefits and why.
“In our CD10 Covid mild-to-moderate trial with leronlimab, we noted a reduction in adverse events or symptoms including fatigue, diarrhoea, chest pain, fatigue, muscle weakness, and anxiety in treated versus placebo groups.”
Enrolment is progressing in the Phase II trial for Covid-19 long-haulers in various hospitals and clinics throughout the US.
CytoDyn president and CEO Nader Pourhassan said: “With strong CD12 results, NASH and long-hauler results not too far away, along with our BLA submission for HIV coming up, we are more confident than ever about the future of leronlimab for many indications.
“We are also equally very excited about our cancer trial and ready to file for a Breakthrough Therapy Designation meeting with the FDA this month.”