CytoDyn Inc. (OTCQB: CYDY) reported this morning that it has started its phase 3 clinical trial to consider the company’s investigational drug leronlimab to treat critically ill COVID-19 patients. The biotech company announced that it has started treating its first critically ill patient in Brazil.
This specific trial focuses on the possibility of the drug candidate to treat COVID-19 patients who require mechanical and invasive ventilation. The drug is administered via intravenous therapy in four doses of 700 mg for four weeks.
Leronlimab is a humanized monoclonal antibody targeted against a specific receptor in a human’s T-cell to trigger an immune system response. The US Food and Drug Administration previously granted the firm a fast track designation to use the candidate drug as a possible treatment for HIV-related diseases and metastatic cancer.
The trial is in parallel with another phase 3 trial for the same drug but is meant for patients with severe COVID-19 symptoms.
“The CytoDyn team, along with BIOMM and ARO, have worked diligently to initiate two pivotal Phase 3 trials in Brazil, and we are excited about the trials’ potential results,” said CytoDyn CEO Nader Pourhassan, Ph.D. “We are hopeful to be in a position to make leronlimab available for patients with severe or critical symptoms in the coming months.”
Following the treatment of the first COVID-19 patient in Brazil, a 28-day interim analysis will be conducted which will determine the further enrollment of 127 more patients to the trial.
Earlier this month, the biotech firm pursued legal actions against its former contract research organization Amarex Clinical Research for alleged breach of contract.
CytoDyn last traded at $1.5 on the OTCQB.
Information for this briefing was found via Sedar and the companies mentioned. The author has no securities or affiliations related to this organization. Not a recommendation to buy or sell. Always do additional research and consult a professional before purchasing a security. The author holds no licenses.