CytoDyn Inc (OTCQB:CYDY), which is developing its flagship drug leronlimab (PRO 140) to battle multiple diseases, said Wednesday that its Phase 2 study of leronlimab for mild-to-moderate coronavirus (COVID-19) patients has been selected for an oral presentation at the upcoming "Special isirv-Antiviral Conference on Therapeutics for COVID-19.”
The three-day conference starting on October 6 is sponsored by the UK-based International Society for Influenza and other Respiratory Virus Diseases.
“The acceptance of this oral abstract by this highly regarded scientific organization is very rewarding for all of the medical professionals who provided care and treatment to the COVID-19 patients during our Phase 2 trial,” said CytoDyn CEO Nader Pourhassan.
“We also view this acceptance as a validation of leronlimab as a potential therapeutic for this disease and we look forward to the upcoming interim analysis from our Phase 3 trial for severe-to-critical COVID-19 patients.”
Vancouver, Washington-based CytoDyn completed its Phase 2 trial to evaluate the effectiveness and safety of leronlimab in patients with mild-to-moderate symptoms caused by COVID-19 infection in July this year.
Patients were randomized to receive weekly doses of 700 mg leronlimab, or placebo. Leronlimab and placebo were administered through injections. The patients receiving leronlimab experienced 64% fewer serious adverse events (SAEs) during the trial than patients receiving placebo
The Phase 2 clinical trial for mild-to-moderate patients in the US produced statistically significant results for NEWS2. Enrollment continues in CytoDyn’s Phase 3 randomized clinical trial for severe-to-critically ill COVID-19 patients in several hospitals in the US. An interim analysis on the first 195 patients will be shared by mid-October.
Details of the presentation are as follows:
- Abstract Title: A Phase 2 Study of Leronlimab for mild-to-moderate coronavirus disease (COVID-19).
- Abstract Confirmation Number: AAVGV0010
- Presenter: Harish Seethamraju, medical director, Advanced Lung Failure and Lung Transplant, Montefiore Medical Center, Bronx, New York.
- Presentation Date: October 6-8, 2020
- Time: 12.00-4.00pm GMT and will be available on demand.
- Additional details can be found on the conference web site here
The FDA has granted Fast Track designation to CytoDyn for two potential indications of leronlimab for critical illnesses. The first as 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 [email protected]com
Follow her on Twitter: @UttaraProactive