CytoDyn Inc said it has received a positive response from the US Food and Drug Administration (FDA) to conduct a Phase III randomized, double-blind, placebo-controlled trial for evaluating the efficacy and safety of leronlimab on critically ill coronavirus (COVID-19) pneumonia patients.
The trial will be performed in combination with the standard of care for COVID-19 pneumonia patients with the need for Invasive Mechanical Ventilation (IMV) or Extracorporeal Membrane Oxygenation (ECMO), the company said. Patients in the trial will be randomized in a 1:1 ratio to receive up to four doses of 700 mg leronlimab with a standard of care or placebo with a standard of care administered via IV infusion weekly over a four-week treatment period.
“As COVID-19 cases continue to surge in the U.S., we are grateful for the opportunity to move forward with the Phase 3 trial of leronlimab as a treatment option for critically ill COVID-19 patients. There continues to be an immense need for therapeutic options to support this population, and we are optimistic that Phase 3 will show promising results,” said Nader Pourhassan, CytoDyn’s CEO in a statement.
He added: “In previous trials, we had issues with our CRO that we now have overcome, and are very excited that the FDA in their recent communication with CytoDyn has stated, ‘As there are now several completed, ongoing, or planned randomized trials of PRO140 (leronlimab) that include severe or critical hospitalized COVID-19 patients, any integrated or meta-analysis would be strengthened if you prespecified analysis details and submitted these for review before results of ongoing or planned trials are Unblinded.," he added.
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Pourhassan noted that since the beginning of the current pandemic, leronlimab has received about 100 eINDs approved by the FDA for use in critically ill COVID-19 patients in the US, and as a result of these FDA approved eINDs and strong results from most of them, physicians have published four papers in peer review journals.
Meanwhile, leronlimab has also been used in the Philippines, under compassionate Special Permit for a fee by over 240 patients with a very high rate of success.
“All these accomplishments along with our current trials in Brazil, we are very hopeful that we will be part of the solution to the current pandemic in the U.S. and abroad, especially in the critically ill population,” Pourhassan said.
The FDA has also granted CytoDyn Fast Track designation to explore two potential indications using leronlimab to treat Human Immunodeficiency Virus (HIV) and metastatic cancer. The first indication is combination therapy with HAART for HIV-infected patients, and the second is for metastatic triple-negative breast cancer (mTNBC).
Leronlimab is an investigational humanized IgG4 mAb that binds to CCR5, a cellular receptor important in HIV infection, tumor metastases, and other diseases, including nonalcoholic steatohepatitis (NASH). Leronlimab has been studied in 16 clinical trials involving more than 1,200 people and met its primary endpoints in a pivotal Phase 3 trial.
Contact Ritika at ritika@proactiveinvestors.com