CytoDyn Inc (OTCMKTS:CYDY) has made a statement regarding its treatment of the first patient with its much-touted about drug candidate leronlimab (Vyrologix or PRO 140), in a crucial Phase 3 Covid-19 trial in Brazil. The treatment is for patients with severe symptoms. After the enrolment of 245 patients (40% of the total number in the trial), an interim analysis will be conducted after 28 days. The trial is being conducted by the Albert Einstein Israelite Hospital (AEIH) in São Paulo, Brazil.
The trial is focused on providing Brazil’s regulatory authority ANVISA (Agência Nacional de Vigilância Sanitária) with proper data to consider enhancing the availability of leronlimab to citizens of the country who are infected with Covid-19. As of now, it will be conducted in around 35 clinical sites with 612 patients who are hospitalized and require oxygen support.
Enrolment is well underway, so CytoDyn looks to reach the interim analysis target soon. CEO Nader Pourhassan is optimistic that the second trial in Brazil will initiate soon, as ANVISA has cleared the trial with a condition of more information about CMC. A few months back, they have signed an exclusive supply and distribution agreement with BIOMM S.A. in Brazil, to enable the latter to sell leronlimab in Brazil after it gets regulatory clearance.
Market Reaction:
On Tuesday, CYDY stock fell 3.29% at $1.61 with more than 2.47 million shares, compared to its average volume of 2.07 million shares. The stock has moved within a range of $1.5000 – 1.7000 after opening the trade at $1.6150.
