CytoDyn says 20 patients enrolled and dosed so far in Vyrologix trial in coronavirus long-haulers

CytoDyn Inc (OTCQB:CYDY) announced Thursday that 20 patients have been enrolled and dosed in the first 10 days of its Phase 2 trial of its drug Vyrologix (leronlimab-PRO 140) as a treatment for COVID-19 long-haulers symptoms.  The randomized, double-blind, placebo-controlled trial is designed to enroll 50 patients, with each receiving eight weekly doses of Vyrologix (or a placebo), followed by four weeks of safety evaluation. The endpoint measure will be at day 56, and trial data is expected by mid-summer, the company said.  “This trial represents a potential solution for many patients with post-acute sequelae from COVID-19 (PASC) known as long-haulers where currently no treatment is available,” VP of Clinical Development Christopher Recknor said in a statement.  READ: CytoDyn says Phase III trial shows safety, mortality reduction, and faster hospital discharge for COVID-19 patients treated with leronlimab “Patients in the trial have had lingering symptoms for over 12 weeks and they need help," he added. "We are looking at sophisticated biomarkers that will help us identify who benefits and why. This group of afflicted patients may represent a signal for all those who have had other post-viral complications and have lost their quality of life since the virus.” Recknor noted that coronavirus long-haulers complained of similar symptoms as people with chronic fatigue syndrome. “In our CD10 COVID mild-to-moderate trial with leronlimab, we noted a reduction in adverse events or symptoms including fatigue, diarrhea, chest pain, fatigue, muscle weakness and anxiety in treated vs. placebo groups,” Recknor said. “Since the CD10 trial did not have a restriction on the time from diagnosis of when COVID was made, some patients were post-COVID several weeks and may have been in the initial stages of PASC. Our job is to use what we learned from prior trials and show that Vyrologix can help.” Enrollment continues in the Phase 2 clinical trial for COVID-19 long-haulers in several hospitals and clinics throughout the US, including Recknor’s own Center for Advanced Research & Education LLC in Gainesville, Georgia. “We are pleased to initiate this much-awaited trial,” CEO Nader Pourhassan said. “Our NASH trial has similarly enrolled 20 patients and is moving forward with rapid speed, thanks to Dr. Chris Recknor, who is in charge of both programs. 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.” Leronlimab works by mitigating what is known as the cytokine storm, a hyperactive immune response that can cause inflammation, fatigue and, in severe cases, organ failure. Aside from COVID-19, the FDA has granted Fast Track designation to CytoDyn for two potential indications of leronlimab for critical illnesses. The first is a combination therapy with HAART for HIV-infected patients and the second is for metastatic triple-negative breast cancer. Contact Andrew Kessel at andrew.kessel@proactiveinvestors.com Follow him on Twitter @andrew_kessel