CytoDyn Reaches Enrollment Target of 293 Patients for 2nd DSMC Interim Analysis of Phase 3 COVID-19 Trial and Expects to Enroll the Remaining 97 Patients in the Next Few Weeks to Complete the Trial This Year
Concurrently, CytoDyn is working diligently with the FDA to initiate its Phase 2 COVID-19 Long
Hauler Trial, with more than 100 volunteers wanting to enroll
VANCOUVER, Washington, Nov. 23, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (“CytoDyn” or the “Company"), a late-stage biotechnology company developing Vyrologix (leronlimab-PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced today it has reached enrollment of 293 patients in its Phase 3 trial for COVID-19 patients with severe-to-critical symptoms, thereby meeting the requested criteria for a second interim efficacy analysis by the Data Safety Monitoring Committee (DSMC).
After the first interim analysis, the DSMC requested a second interim analysis of all data after enrollment had reached 293 patients or 75% of the total patients for the trial. Approximately five weeks ago, the DSMC completed the first interim analysis on 195 patients (or 50% of the 390 planned patients) and recommended the trial continue without modification to achieve the primary endpoint and requested another interim analysis when enrollment reached 75% level (or 293 patients) to review patient mortality and other clinical outcome data.
Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn, commented, “In addition to filing our biologics license applications in Canada and the U.K. for HIV, the Company is in full swing to obtain full enrollment in the Phase 3 COVID-19 trial before year end and initiate our Phase 2 trial for COVID-19 patients with multiple long-hauler symptoms and perhaps complete enrollment in 4-6 weeks. On another front, CytoDyn is also about to enroll its first patient in the NASH trial this month. We are very appreciative of the all-out effort by our clinical operations team (especially Mr. Brian Brothen, the Company’s SVP of Global Oncology, and Dr. Kush Dhody from Amarex) and the clinical sites to expedite enrollment in this important trial and are hopeful the DSMC can complete their second interim analysis as quickly as possible. We continue to advance enrollment, without any pause to achieve the trial’s planned 390 patients and we are currently evaluating the ability to conduct an interim analysis as soon as possible. In the meantime, if the pace of enrollment we have experienced in the last two weeks continues, we will have the CD12 enrollment completed before the end of the year. These are exciting times for the Company and I am honored to be working alongside such dedicated co-workers.”