CytoDyn Inc has announced the treatment of the first patient with its flagship drug candidate leronlimab (Vyrologix or PRO 140) in a pivotal Phase 3 coronavirus (COVID-19) trial in Brazil for patients with severe symptoms.
The Vancouver, Washington-based late-stage biotechnology company said an interim analysis will be conducted 28 days following the enrollment of 245 patients, which is 40% of the total number of patients to be enrolled in the trial.
As previously announced, the pivotal Phase 3 trial for severe COVID-19 patients is being conducted by an Academic Research Organization (ARO) called Albert Einstein Israelite Hospital (AEIH) in São Paulo, Brazil.
READ: CytoDyn has multiple shots on goal with its flagship drug Vyrologix to treat HIV, various cancers and even coronavirus
The trial aims to provide Brazil’s regulatory authority ANVISA (Agência Nacional de Vigilância Sanitária) with the requisite data to consider advancing the availability of leronlimab to Brazilians infected with COVID-19. “The trial will be conducted in up to 35 clinical sites with 612 patients who are hospitalized and in need of oxygenation support,” said the company.
In a statement, CytoDyn CEO Nader Pourhassan said: “We are very encouraged as enrollment for this first trial is underway and look forward to reaching our interim analysis target as soon as possible. We believe our second trial in Brazil will also initiate very soon as ANVISA has cleared the trial with a condition of more information about CMC, which will be provided to ANVISA no later than September 13.”
“Today marks the first day of the much-anticipated clinical trial in Brazil that we have been waiting for and we are so grateful to our team who conducted the CD12 trial in the US that produced a wealth of information for us to be able to appropriately design and power these two studies.”
The CytoDyn boss gave a shout-out to the ARO team “for a job well done” and said the company looked forward to “many more trials to be conducted by them in Brazil with leronlimab”.
“We also thank the BIOMM team for exceptional work to finalize this protocol with ANVISA and providing very valuable guidelines to our team,” said CytoDyn.
On April 7, 2021, CytoDyn signed an exclusive supply and distribution agreement with BIOMM S.A. in Brazil to enable BIOMM to sell leronlimab in Brazil following regulatory clearance.
The US Food and Drug Administration (FDA) has 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 a combination therapy with HAART for HIV-infected patients, and the second is for metastatic triple-negative breast cancer (mTNBC).
Contact the author Uttara Choudhury at firstname.lastname@example.org
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