CytoDyn says US FDA accepts protocol for adding open-label extension to its Phase 3 trial; research paper published

CytoDyn Inc. (OTCQB:CYDY) has announced that the US Food and Drug Administration (FDA) has accepted the protocol the group submitted on December 28, 2020, for adding an open-label extension to its Phase 3 trial (CD12).  The late-stage biotechnology company, which is developing Vyrologix (leronlimab-PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, noted that hospitals previously participating in the CD12 trial now have the option of enrolling additional eligible patients, with all patients receiving leronlimab. Treatment for eligible patients will continue until further notified by the FDA and/or CytoDyn.  READ: CytoDyn to add open-label extension to its Phase 3 trial of leronlimab for severe-to-critical COVID-19 patients The group said the FDA also provided specific guidance for the benefit of physicians seeking access to leronlimab under an eIND for coronavirus (COVID-19) patients, which must first meet the inclusion/exclusion criteria of the CD12 study. The agency specified certain subgroups of patients will be excluded from the eIND authorization process: mild/moderate COVID-19, mechanically ventilated with PEEP <15 cmH20 with Pa02/FiO2 >150 mmHg and on vasopressors >48 hours. In a statement, Mahboob Rahman, CytoDyn's chief scientific officer and head of Clinical Development commented: “We appreciate the specificity of the guidance from the FDA, as this will facilitate a prompt and efficient review and approval process for qualified patients. As the pace of this pandemic is not slowing down in the foreseeable future, providing a safe and effective treatment is the highest priority for all.” Nader Pourhassan, CytoDyn's president and chief executive officer added: “We are most thankful to the FDA for their acceptance of the open-label extension to allow access to leronlimab for eligible patients and the definitive criteria provided for the benefit of physicians considering an eIND for their COVID-19 patients.” CytoDyn has completed its Phase 2 clinical trial (CD10) for COVID-19, a double-blinded, randomized clinical trial for mild-to-moderate patients in the US. which produced statistically significant results for NEWS2. The company has completed enrollment of 390 patients in its Phase 2b/3 randomized clinical trial for the severe-to-critically ill COVID-19 population and expects to release results in mid-January 2021. Research manuscript submitted In a separate statement on Thursday, CytoDyn also announced that a research manuscript submitted by Dr Nicholas J. Agresti has been accepted for publication in the Journal of Translational Autoimmunity. Dr Agresti’s research findings were based on four critically ill COVID-19 patients treated with leronlimab under eIND. The manuscript is entitled 'Disruption of CCR5 Signaling to Treat COVID-19-Associated Cytokine Storm: Case Series of Four Critically Ill Patients Treated with Leronlimab.' it can be accessed via the following link: https://d1io3yog0oux5.cloudfront.net/cytodyn/files/pages/cytodyn/db/256/content/JTAUTO-D-20-00043_R1+_3__1_.pdf. Agresti said: “We are very thankful with the clinical outcomes for these patients and are honored by the acceptance of our research for publication. We hope this work will continue to advance research to understand how to effectively mitigate the effects of COVID-19.” CytoDyn's Pourhassan added: “We are appreciative of Dr. Agresti’s work and view his publication as a validation of leronlimab as an important potential therapeutic in the treatment of seriously ill COVID-19 patients. Dr Agresti’s four patients were treated with leronlimab under eIND. All four patients were on mechanical ventilator and they fully recovered.” CytoDyn has successfully completed a Phase 3 pivotal trial with leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients. The FDA met telephonically with Company key personnel and its clinical research organization and provided written responses to the Company’s questions concerning its recent Biologics License Application (BLA) for this HIV combination therapy in order to expedite the resubmission of its BLA filing for this indication. The company has also has completed a Phase 3 investigative trial with leronlimab as a once-weekly monotherapy for HIV-infected patients. CytoDyn plans to initiate a registration-directed study of leronlimab monotherapy indication. If successful, it could support a label extension. Clinical results to date from multiple trials have shown that leronlimab can significantly reduce viral burden in people infected with HIV. CytoDyn is also conducting a Phase 1b/2 clinical trial with leronlimab in metastatic triple-negative breast cancer. Contact the author at jon.hopkins@proactiveinvestors.com