Therapy Areas: AIDS & HIV
CytoDyn Receives Clearance from Brazil's FDA to Commence a Pivotal Phase 3 Trial in Critically Ill COVID-19 Patients with IV Administration of Four Doses (700mg/week)
23 September 2021 - - Brazil's regulatory authority, ANVISA (Agência Nacional de Vigilância Sanitária), has approved the start of an additional Phase 3 CD16 clinical trial of leronlimab, US-based biotechnology company CytoDyn Inc. (OTCQB: CYDY) said.

The new clinical trial will focus on hospitalized COVID-19 patients in critical condition who require mechanical and invasive ventilation or Extracorporeal Membrane Oxygenation.

The trial will be carried out across 22 research centers with a total of 316 patients.

An interim analysis will be conducted after 40% of the patients have been enrolled and have completed a 28-day trial. The first goal for this trial is to enroll 127 patients as soon as possible.

The Academic Research Organization Albert Einstein Israelite Hospital in Brazil will conduct the trial in coordination with CytoDyn and BIOMM, the company's exclusive partner for the commercialization of leronlimab in Brazil.

Absorption of leronlimab into the body occurs within one to two hours post IV administration. In contrast, SQ injection could be two to three days before leronlimab is completely absorbed.

CytoDyn is a late-stage biotechnology company developing innovative treatments for multiple therapeutic indications using leronlimab, a novel humanized monoclonal antibody targeting the CCR5 receptor.

CCR5 plays a critical role in the ability of HIV to enter and infect healthy T-cells and appears to be implicated in tumor metastasis and immune-mediated illnesses, such as NASH.

CytoDyn successfully completed a Phase 3 pivotal trial using leronlimab combined with standard antiretroviral therapies in HIV-infected patients who were heavily treatment-experienced individuals with limited treatment options.
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