CytoDyn Inc (OTCQB:CYDY), a biotechnology company developing its flagship drug Vyrologix (leronlimab-PRO 140) for multiple indications, revealed that its coronavirus (COVID-19) long-haulers study (CD15) is now fully enrolled.
The Vancouver, Washington-based biotechnology company noted that enrollment was “faster than expected” because of the high number of patients wanting to participate, which now includes 56 patients in the trial.
This is a multicenter Phase 2, two-arm, randomized, double-blind, placebo-controlled study to evaluate the safety and effectiveness of Vyrologix in the treatment of patients with prolonged COVID-19 symptoms, a condition now known as Post-Acute COVID Syndrome (PACS).
READ: CytoDyn says 20 patients enrolled and dosed so far in Vyrologix trial in coronavirus long-haulers
Patients will be given eight weekly doses of Vyrologix or placebo, said the company. The final treatment for the last enrolled patient will be in early June, with results expected in July.
In a statement, CytoDyn Chief Operating Officer Chris Recknor said: “These patients have been suffering from COVID-19 symptoms for more than 12 weeks, many for more than six months. After reviewing the results from our earlier CD10 trial involving patients with mild-to-moderate COVID-19, we recognized Vyrologix may be a solution to PACS and have since developed a better understanding of the mechanism of action and how Vyrologix works in PACS.”
“We believe CytoDyn is now well-positioned to potentially be the first to offer an effective treatment for this condition, where no other therapy is currently available,” he added.
Meanwhile, Scott Kelly, who is the chief medical officer and head of CytoDyn’s business development, noted that PACS is “rapidly evolving” into a “global health emergency.”
“At the current rate of COVID-19 infections, global cases are expected to exceed 200 million by the end of 2021. It is estimated 10-30% of those infected will have persistent symptoms, leaving 20 to 60 million patients without effective treatment options,” added Kelly.
Kelly noted that coronavirus long-haulers complained of similar symptoms as people with Chronic Fatigue Syndrome, where the fatigue worsens with activity but doesn’t improve with rest.
“PACS is devastating to patients’ quality of life, and its economic impact is ruinous. PACS shares many features of Chronic Fatigue Syndrome/Myalgic Encephalomyelitis (CFS/ME), and approximately 50-75% of CFS/ME patients are unable to work or attend school,” added Kelly. “If Vyrologix is successful in treating PACS, then trials in other post-viral syndromes will be the logical next step.”
CytoDyn’s flagship drug Vyrologix also 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 in COVID-19 patients.
Aside from COVID-19, the US Food & Drug Administration (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 the author Uttara Choudhury at uttara@proactiveinvestors.com
Follow her on Twitter: @UttaraProactive