RIO DE JANEIRO, BRAZIL – Biomm informed, in a material fact sent to the Brazilian Securities and Exchange Commission (CVM) this evening, that it has entered into an exclusive agreement with the company CytoDyn Inc. for the potential supply of the drug Leronlimab in Brazil.
CytoDyn, headquartered in Vancouver, Washington (USA), is a biotechnology company that is in the process of developing innovative treatments for multiple therapeutic indications.
Considering the possible use of Leronlimab in the treatment of patients diagnosed with Covid-19 who are hospitalized and in need of oxygenation, CytoDyn has requested its emergency use from the FDA (Food and Drug Administration) in the United States, Health Canada, and the MHRA – Medicines and Healthcare Products Regulatory Agency in the United Kingdom.
Leronlimab
Leronlimab (codenamed PRO 140, tentative trade name Vyrologix) is being investigated as a potential therapy in treating COVID-19, triple-negative breast cancer, and HIV infection.
The United States Food and Drug Administration has designated PRO 140 for fast-track approval. In February 2008, the drug entered Phase 2 clinical trials, and a phase 3 trial was begun in 2015. In February 2018, Cytodyn Inc reported that the primary endpoint had been achieved in the PRO 140 pivotal combination therapy trial in HIV infection.
https://www.youtube.com/watch?v=W84-ORWbKPM&ab_channel=EUAforLeronlimab-THECOVIDLifeline
In 2020 CytoDyn submitted a fast-track biologics license application for treatment of CCR5-tropic HIV-1 Infection. In August 2020, CytoDyn submitted an emergency use authorization for the treatment of mild to moderate COVID-19.
Phase III trial for Leronlimab in COVID-19 patients disappoints
CytoDyn reported at the beginning of March 2021 on the Phase III trial of Leronlimab to treat severe-to-critical patients with COVID-19.
Despite the company putting a positive spin on the data, saying continued safety, substantial improvement in the survival rate, and faster hospital discharge in critically ill COVID-19 patients had been demonstrated, investors did not buy it, and CytDyn saw its shares tank 28% to US$2.91 by close of trading.
With information from Valor Investe