CytoDyn’s CRO in Brazil Met with ANVISA to Modif
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Posted On: 12/08/2021 8:46:51 AM
CytoDyn’s CRO in Brazil Met with ANVISA to Modify CD16 Trial for Critically Ill COVID-19 Patients to Expedite Interim Analysis After 51 Patients, Potentially in 1Q2022
DSMB to meet after 15 patients to evaluate safety of Leronlimab
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 its CRO in Brazil (Academic Research Organization (ARO) Albert Einstein Israelite Hospital (AEIH)) met with the Brazilian Health Regulatory Agency (ANVISA) and received its agreement to modify the CD16 trial for critically ill COVID-19 patients. ANVISA has authorized CytoDyn to submit the requested changes. CytoDyn will submit the revised protocol for CD16 providing for a reduction in total enrollment from 330 to 126 patients, with interim efficacy analysis by DSMB after 40% of patients (51 patients) are enrolled and have completed follow-up to Day 28 .
In this trial, patients will be randomized in a 1:1 ratio to receive up to four weekly doses of 700 mg of leronlimab or placebo via IV infusion. By comparison, in the previous CD12 trial (a phase 3 trial for COVID-19 severe-to-critical ill patients) in the USA, patients received only two weekly doses of 700 mg of leronlimab via sub-cutaneous injections.
The subgroup analyses of 62 critically ill patients in the CD12 trial showed an 82% survival benefit at Day 14 after two doses of leronlimab on Day 0 and Day 7 (Odds Ratio 0.09 (CI 0.01, 0.72), p-value 0.0233) vs. standard-of-care plus placebo. The survival benefit fell from 82% after 2 more weeks to 30% after four weeks. The survival rate on Day 28 could be much better with four 700mg, IV doses of leronlimab administered on Day 0, 7, 14, and 21.
Nader Pourhassan, Ph.D., CytoDyn’s President and Chief Executive Officer, commented, “We are optimistic that our CRO in Brazil will be able to enroll 51 patients and conduct an interim analysis of the results in 1Q2022, with the potential for meeting the primary endpoint at the time of interim analysis. The primary endpoint in this study was based on the valuable information we had generated from the past CD12 trial. The p-value for length of hospital stay for the critically ill patients who were on invasive mechanical ventilator or ECMO was 0.005. The primary endpoint of the CD16 trial in Brazil is Time to Recovery, which is similar to this endpoint. Due to this past result from CD12 which was obtained with two sub-cutaneous doses of leronlimab, we believe four doses via IV will give us an excellent chance of success.”
https://www.cytodyn.com/newsroom/press-releas...odify-cd16
DSMB to meet after 15 patients to evaluate safety of Leronlimab
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 its CRO in Brazil (Academic Research Organization (ARO) Albert Einstein Israelite Hospital (AEIH)) met with the Brazilian Health Regulatory Agency (ANVISA) and received its agreement to modify the CD16 trial for critically ill COVID-19 patients. ANVISA has authorized CytoDyn to submit the requested changes. CytoDyn will submit the revised protocol for CD16 providing for a reduction in total enrollment from 330 to 126 patients, with interim efficacy analysis by DSMB after 40% of patients (51 patients) are enrolled and have completed follow-up to Day 28 .
In this trial, patients will be randomized in a 1:1 ratio to receive up to four weekly doses of 700 mg of leronlimab or placebo via IV infusion. By comparison, in the previous CD12 trial (a phase 3 trial for COVID-19 severe-to-critical ill patients) in the USA, patients received only two weekly doses of 700 mg of leronlimab via sub-cutaneous injections.
The subgroup analyses of 62 critically ill patients in the CD12 trial showed an 82% survival benefit at Day 14 after two doses of leronlimab on Day 0 and Day 7 (Odds Ratio 0.09 (CI 0.01, 0.72), p-value 0.0233) vs. standard-of-care plus placebo. The survival benefit fell from 82% after 2 more weeks to 30% after four weeks. The survival rate on Day 28 could be much better with four 700mg, IV doses of leronlimab administered on Day 0, 7, 14, and 21.
Nader Pourhassan, Ph.D., CytoDyn’s President and Chief Executive Officer, commented, “We are optimistic that our CRO in Brazil will be able to enroll 51 patients and conduct an interim analysis of the results in 1Q2022, with the potential for meeting the primary endpoint at the time of interim analysis. The primary endpoint in this study was based on the valuable information we had generated from the past CD12 trial. The p-value for length of hospital stay for the critically ill patients who were on invasive mechanical ventilator or ECMO was 0.005. The primary endpoint of the CD16 trial in Brazil is Time to Recovery, which is similar to this endpoint. Due to this past result from CD12 which was obtained with two sub-cutaneous doses of leronlimab, we believe four doses via IV will give us an excellent chance of success.”
https://www.cytodyn.com/newsroom/press-releas...odify-cd16
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