CytoDyn Inc (OTCQB:CYDY) announced that it has submitted a dose justification report on its Vyrologix (leronlimab-PRO 140) drug to the US Food and Drug Administration (FDA), which will be followed by an official submission for an IND (investigational new drug).
The late-stage biotechnology company is developing leronlimab to battle multiple diseases, including coronavirus (COVID-19). Most significantly, it is working to develop a significant advance in HIV treatment beyond the “AIDS cocktail” combination of pills that has kept millions of people alive since the mid-1990s.
READ: CytoDyn pleased with preliminary results from long-haulers coronavirus trial
The company noted the submission is an integral step in the resubmission process for the Biologics License Application (BLA) for HIV patients with multiple resistance to current standard of care. The dose justification report is a key component for the BLA and includes receptor occupancy analysis, among other factors, to determine the optimal marketed dose for leronlimab.
Following FDA feedback on this critical step, the company will begin submission of BLA modules by specified timelines in accordance with FDA guidance and approval.
“We have a great molecule with many opportunities being evaluated in parallel to the BLA, including COVID, NASH and Oncology,” CytoDyn’s chief operating officer and head of clinical development Dr Chris Recknor said in a statement.
“We are on track for the top-line report for the COVID-19 long-haulers symptoms/biomarker trial and will soon start two COVID-19 trials in Brazil,” he added.
CytoDyn also said its Phase 2 NASH (nonalcoholic steatohepatitis) trial has enrolled the 60th patient on schedule and it is currently working on its CCR5 solid tumor cancers basket trial. Its triple-negative breast cancer dose-escalation portion is completed with the main trial beginning in July.
“Dr Recknor and the team he has assembled in a short period of time continue to comprehensively address the previously noted deficiencies in our initial BLA submission, while concurrently pushing forward with our complete agenda for 2021,” said CytoDyn president and CEO Dr Nader Pourhassan.
“The HIV BLA is a significant undertaking, and we are very encouraged about our progress. Since the commencement of clinical trials with leronlimab about 7 years ago, we have positioned leronlimab for potential approval for multiple indications, namely, 22 solid tumor cancers, NASH, and three indications in COVID-19, and the opportunities continue to grow,” he added.
Contact the author at stephen.gunnion@proactiveinvestors.com