CytoDyn Inc (OTCQB:CYDY) said a Phase III trial of its leronlimab treatment, known as Vyrologix, for severe-to-critical patients with coronavirus (COVID-19) has demonstrated continued safety, a substantial improvement in the survival rate, and faster hospital discharge in critically ill COVID-19 patients.
The biotechnology company said the trial data has been reported to the US Food and Drug Administration (FDA), the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), and Health Canada (HC), and that it is in discussions with each regulator to determine the best path forward for the approval of leronlimab for the treatment of COVID-19 in the critically ill population. A manuscript of the trial’s data is also being prepared and will be submitted for publication in one or more major medical journals.
READ: CytoDyn says data from its Phase 2b/3 Vyrologix coronavirus trial will be made public, pending regulatory talks
Highlights of the trial data included a 24% reduction in all-cause mortality in patients treated with leronlimab versus placebo, as well as a reduction in the average length of hospital stay by six days and an improved probability of being “discharged alive” at Day 28.
CytoDyn also said that given the size of this critically ill population relative to the trial’s size (62 out of 384 patients), it has concurrently filed an additional protocol with the FDA using the existing sites from its CD12 trial to quickly enroll patients in this population during the pendency of these ongoing regulatory discussions. The company added that it has continued to enroll patients through the open-label arm of the CD12 trial and is working with regulators to expedite this process.
“Today, there are no approved drugs to effectively address the unmet medical need for critically ill COVID-19 patients. Our CD12 study demonstrates leronlimab is particularly effective in treating this patient population. We believe these results are the best results ever achieved for this population in a Phase III clinical trial. A recently approved IL-6 blocker used to treat severe to critical hospitalized COVID-19 patients requiring mechanical ventilation, reduced mortality by 2% compared to the placebo group,” CytoDyn President and Chief Executive Nader Pourhassan said in a statement.
“In contrast, leronlimab demonstrated a reduction of 24% in mortality compared to the SoC treated group, which is 12 times better in reducing all-cause mortality for critically ill COVID-19 patients. The company is very excited about these results and is concurrently working with regulators here and abroad to expedite leronlimab’s approval to treat COVID-19,” he added.
In a separate announcement, the company said that the MHRA has told the company it will accept more data from the open-label portion of the current CD12 trial, and that to date, an additional 46 patients have been enrolled, but the results have not yet been communicated to any agency.
CytoDyn also said it anticipates that a Health Canada Interim Order (IO) could allow it to sell leronlimab in Canada, while additional critical COVID-19 patients are enrolled. These discussions are ongoing, it said, adding that it has also initiated the process to submit an IO with Health Canada.
The group also confirmed that the FDA has received its protocol for enrolling 140 critically ill COVID-19 patients with the primary endpoint defined as the length of hospital stay.
CytoDyn added that it has performed an “age adjustment” analysis on its data for critically ill COVID-19 patients, which it said showed “consistent numerical superiority over the placebo group, with some secondary endpoints approaching statistical significance”.
“We are grateful for the chance to help critically ill COVID-19 patients. We continue to be pleased with the results from over 80 EINDs, 394 patients in CD12, and another 46 patients in the continuation of CD12’s open-arm access, as well as the results published in two different peer- reviewed journals,” Pourhassan said.
“I am humbled by comments from the families whose lives they believe were saved with leronlimab and we look forward to making leronlimab more readily available to treat patients with COVID-19 and many other indications we are working on. I’m excited to address our investment community on Monday and to congratulate our entire extended team for their tireless support of the leronlimab program,” the CEO added.
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Story by ProactiveInvestors
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