Vancouver based late-stage biotechnology company CytoDyn Inc. has reportedly announced that it will apply for pre-submission meeting requests for leronlimab in the UK as HIV treatment in combination with HAART for high treatment-experienced HIV patients. It will also seek approval for leronlimab for COVID-19 patients with mild-to-moderate symptoms (Phase 2 - CD10).
Along with the Clinical Trial Summary (CSR), CytoDyn will have the Phase 2 topline test. Afterward, the company will prepare requests for pre-submission meetings in European Union member countries.
The submission to Medicines and Healthcare Products Regulatory Agency (MHRA), U.K. based executive agency which is sponsored by the Department of Health and Social Care, will start the process to pursue approval for leronlimab as a combination therapy for HIV patients using a 350 mg weekly dose for CytoDyn.
Phase 3 trial for leronlimab has already been completed by the company, as a combination therapy for highly treatment HIV patients for the trial based on a 350 mg dosage.
As per people familiar with the knowledge of the matter, the purpose of the Phase 2 trial was to evaluate the safety and efficiency of leronlimab in patients with COVID-19 who are showing mild-to-moderate symptoms. The same was completed in July 2020.
Random patients received 700 mg leronlimab or placebo weekly doses via subcutaneous injection. Patients receiving leronlimab had recorded 64% fewer SAE’s (serious adverse events) during the clinical trial than patients receiving placebo.
A separate DSMC (Data Safety Monitoring Committee), which reported no findings of justification to change its analysis, reviewed ongoing phase 3 (CD12) of CytoDyn leronlimab research in patients with moderate to serious COVID-19. There are now 173 registered patients in Phase 3 research, and after registering 195 patients, they will perform a full interim review as set out in the trial protocol.