CytoDyn Inc (OTCQB:CYDY) said Monday that the US Food and Drug Administration (FDA) has sought more information from the company to complete a substantive review of its flagship drug leronlimab for the treatment of HIV in combination with the cocktail known as highly active antiretroviral therapy (HAART).
The Vancouver, Washington-based late-stage biotechnology company said it is “confident” it can provide “all information requested by the FDA.”
On May 11, CytoDyn reported that it had submitted all remaining parts of its Biologics License Application (BLA) for leronlimab. In keeping with guidelines, CytoDyn informed the FDA it had submitted a complete BLA for rolling review. The FDA has now informed the company its BLA doesn’t contain certain information needed to complete a substantive review, and has therefore not filed the BLA at this time.
CytoDyn said it intends to request a Type A meeting with the FDA to discuss its request for additional information. Significantly, the FDA’s request does not require any additional clinical trials to be conducted, rather the company will conduct additional analysis of completed trials.
In a statement, CytoDyn CEO Nader Pourhassan said: “We are 100% committed and confident we can provide the necessary information to the FDA as soon as possible. No additional trials will be required and all the information the FDA has requested is obtainable.”
Leronlimab was previously granted Fast Track designation by the FDA for the treatment of HIV in combination with HAART, and for metastatic triple-negative breast cancer, a rare variety which doesn’t respond to some treatments.
For coronavirus (COVID-19) treatment, the FDA has granted a so-called rolling review for the drug as part of CytoDyn's BLA application submission. The company has been granted more than 60 emergency Investigational New Drug authorizations by the FDA and plans to provide clinical updates for this patient population in the coming weeks.
In July, CytoDyn started enrolling a Phase 2b/3 clinical trial for 390 severe and critically ill COVID-19 patients, which were randomized in a 2:1 ratio, in an active drug to placebo-controlled trial.
CytoDyn also said it has met its 75-patient enrollment target in its Phase 2 clinical trial for COVID-19, a randomized clinical study for mild-to-moderate COVID-19 patients in the US.
“While we await upcoming results in our two major COVID-19 Phase 2 and Phase 3 trials, we are confident July will be a very important month for our shareholders,” said Dr Pourhassan.
“I understand many of our shareholders are very eager to see these results soon and I welcome the opportunity to answer any questions from our shareholders during today’s conference call held by the company,” he added.
Dr Pourhassan, CytoDyn chief medical officer Scott Kelly, CytoDyn chief technology officer Nitya Ray, and Kush Dhody, the senior VP of clinical operations at Amarex Clinical Research will host an investment community conference call on July 13, at 1:00 pm PT/4:00 pm ET to provide an update on the regulatory developments.
Management will address questions from analysts and investors after opening remarks by the CEO.
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