CytoDyn Receives Clearance from Brazil’s FDA (ANVISA) to Commence a Pivotal Phase 3 Trial in Critically Ill COVID-19 Patients with IV Administration of Four Doses (700mg/week)
Download as PDFSeptember 22, 2021 8:00am EDT
VANCOUVER, Wash.--(BUSINESS WIRE)-- CytoDyn Inc. (OTCQB: CYDY) (“CytoDyn” or the “Company”), a late-stage biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, today announced that Brazil’s regulatory authority, ANVISA (Agência Nacional de Vigilância Sanitária), has approved the start of an additional Phase 3 CD16 clinical trial of leronlimab.
The new clinical trial will focus on hospitalized COVID-19 patients in critical condition who require mechanical and invasive ventilation or Extracorporeal Membrane Oxygenation (ECMO). 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 (ARO) Albert Einstein Israelite Hospital (AEIH) in Brazil will conduct the trial in coordination with CytoDyn and BIOMM, the Company’s exclusive partner for the commercialization of leronlimab in Brazil.
Nader Pourhassan, Ph.D., CytoDyn’s President and Chief Executive Officer, commented:
“We are excited about this news and what it means for leronlimab’s potential ability to successfully treat critically ill COVID-19 patients in the future all over the world. We believe the IV treatment in this trial will have an enormous advantage over treatment via subcutaneous (SQ) injections, which was the route of administration in our last COVID-19 trial (CD12) in the US.
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. With a critically ill population, time is of the essence. In the previous trial (CD12), we believe that the 30% survival benefit (after 28 days) in the leronlimab arm versus placebo could have been much higher if IV administration had been used instead of SQ and if the treatment was with four dosages instead of only two.
Furthermore, in our CD12 study, the survival benefit in the critically ill population was 78% after the first-week post the first dose of leronlimab and 82% after the second week. The treatment with leronlimab was only for two doses (day 0 and day 7); from day 14 to 28, the survival rate declined from 82% to 30%, respectively in the absence of additional doses of leronlimab. In this trial (CD16), there will be four doses during the first four weeks of treatment, and with IV administration, we believe our chance of success is much improved. Furthermore, the primary endpoint in this study (CD16) is time to recovery. This similar endpoint in the previous study (CD12) showed the time to discharge from hospital to be 166% better than placebo in the critically ill population. This is why we are very excited to see the results of the interim analysis. We continue to be grateful to the ARO and BIOMM teams for their work in getting us to this point.”
About CytoDyn
Download as PDFSeptember 22, 2021 8:00am EDT
VANCOUVER, Wash.--(BUSINESS WIRE)-- CytoDyn Inc. (OTCQB: CYDY) (“CytoDyn” or the “Company”), a late-stage biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, today announced that Brazil’s regulatory authority, ANVISA (Agência Nacional de Vigilância Sanitária), has approved the start of an additional Phase 3 CD16 clinical trial of leronlimab.
The new clinical trial will focus on hospitalized COVID-19 patients in critical condition who require mechanical and invasive ventilation or Extracorporeal Membrane Oxygenation (ECMO). 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 (ARO) Albert Einstein Israelite Hospital (AEIH) in Brazil will conduct the trial in coordination with CytoDyn and BIOMM, the Company’s exclusive partner for the commercialization of leronlimab in Brazil.
Nader Pourhassan, Ph.D., CytoDyn’s President and Chief Executive Officer, commented:
“We are excited about this news and what it means for leronlimab’s potential ability to successfully treat critically ill COVID-19 patients in the future all over the world. We believe the IV treatment in this trial will have an enormous advantage over treatment via subcutaneous (SQ) injections, which was the route of administration in our last COVID-19 trial (CD12) in the US.
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. With a critically ill population, time is of the essence. In the previous trial (CD12), we believe that the 30% survival benefit (after 28 days) in the leronlimab arm versus placebo could have been much higher if IV administration had been used instead of SQ and if the treatment was with four dosages instead of only two.
Furthermore, in our CD12 study, the survival benefit in the critically ill population was 78% after the first-week post the first dose of leronlimab and 82% after the second week. The treatment with leronlimab was only for two doses (day 0 and day 7); from day 14 to 28, the survival rate declined from 82% to 30%, respectively in the absence of additional doses of leronlimab. In this trial (CD16), there will be four doses during the first four weeks of treatment, and with IV administration, we believe our chance of success is much improved. Furthermore, the primary endpoint in this study (CD16) is time to recovery. This similar endpoint in the previous study (CD12) showed the time to discharge from hospital to be 166% better than placebo in the critically ill population. This is why we are very excited to see the results of the interim analysis. We continue to be grateful to the ARO and BIOMM teams for their work in getting us to this point.”
About CytoDyn
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