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CytoDyn (CYDY) Files New Protocol With FDA for COVID-19 Study
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CytoDyn Inc. (CYDY - Free Report) announced that it has filed a new protocol with the FDA to evaluate four doses of leronlimab for critical COVID-19 patients.
The company aims to duplicate or surpass 82% survival benefit with p-value of 0.0233, which was originally achieved from two weeks of treatment in CD12 study with two doses.
The decision follows several weeks of discussions with the FDA and an analysis of CD12 study data. CD12 study outcome showed a statistically significant 82% reduction in mortality rate at 14 days for critically ill COVID-19 patients with 400% improvement in clinical outcome based on an ordinal scale with discharge rate much better in leronlimab with a statistically significant p-value.
These results were achieved with just two doses of leronlimab, one dose at day 0 and a second dose at day 7. Based on these impressive findings, the company believes that an increased dosage regimen will lead to an equal or greater mortality benefit.
The company will initiate patient enrollment in multiple countries including Brazil, which currently has 20,000 COVID-19 patients in ICU. CytoDyn believes, four weeks of leronlimab treatment will be sufficient to calm the cytokine storm and will have a positive effect on the survival rate at four weeks and potentially eight weeks.
Notably, leronlimab is an investigational humanized IgG4 mAb that blocks CCR5, a cellular receptor important for HIV infection, tumor metastases and other diseases including NASH (Nonalcoholic Steatohepatitis).
CytoDyn already completed two studies in COVID-19 patients (a phase II and a phase III) and is in the process of conducting an additional COVID-19 phase III study for mechanically-ventilated critically-ill COVID-19 patients.
The company successfully completed a phase III study evaluating leronlimab combined with standard antiretroviral therapies for HIV-infected treatment-experienced patients. The company is currently working on refiling its Biologics License Application (BLA) for this HIV combination therapy as it received a Refusal to File in July 2020. CytoDyn expects to resubmit its BLA in the first half of the year.
CytoDyn’s stock has lost 49.9% in the year so far compared with the industry's decline of 2.2%.
Most biotech/pharma companies are evaluating every weapon in their arsenal to combat and prevent the coronavirus spread and help the infected.
Kaleido Biosciences, Inc. reported positive results from a study on KB109 in patients with mild-to-moderate COVID-19. Results from a non-Investigational New Drug (IND) study of KB109 in these patients showed a reduction in overall COVID-19-related healthcare utilization comprising hospitalizations, emergency room visits and urgent care visits.
Regeneron’s (REGN - Free Report) investigational antibody cocktail for COVID-19 showed efficacy against the emerging variants. It was granted an Emergency Use Authorization in November 2020 for the treatment of mild-to-moderate COVID-19 in adults as well as pediatric patients who are at least 12 years old and weighing minimum 40 kg. Vir Biotechnology, Inc (VIR - Free Report) and partner GlaxoSmithKline plc submitted an application to the FDA requesting an Emergency Use Authorization (EUA) for their investigational dual-action SARS-CoV-2 monoclonal antibody VIR-7831 (GSK4182136).
It could become the mother of all technological revolutions. Apple sold a mere 1 billion iPhones in 10 years but a new breakthrough is expected to generate more than 77 billion devices by 2025, creating a $1.3 trillion market.
Zacks has just released a Special Report that spotlights this fast-emerging phenomenon and 4 tickers for taking advantage of it. If you don't buy now, you may kick yourself in 2022.
Image: Shutterstock
CytoDyn (CYDY) Files New Protocol With FDA for COVID-19 Study
CytoDyn Inc. (CYDY - Free Report) announced that it has filed a new protocol with the FDA to evaluate four doses of leronlimab for critical COVID-19 patients.
The company aims to duplicate or surpass 82% survival benefit with p-value of 0.0233, which was originally achieved from two weeks of treatment in CD12 study with two doses.
The decision follows several weeks of discussions with the FDA and an analysis of CD12 study data. CD12 study outcome showed a statistically significant 82% reduction in mortality rate at 14 days for critically ill COVID-19 patients with 400% improvement in clinical outcome based on an ordinal scale with discharge rate much better in leronlimab with a statistically significant p-value.
These results were achieved with just two doses of leronlimab, one dose at day 0 and a second dose at day 7. Based on these impressive findings, the company believes that an increased dosage regimen will lead to an equal or greater mortality benefit.
The company will initiate patient enrollment in multiple countries including Brazil, which currently has 20,000 COVID-19 patients in ICU. CytoDyn believes, four weeks of leronlimab treatment will be sufficient to calm the cytokine storm and will have a positive effect on the survival rate at four weeks and potentially eight weeks.
Notably, leronlimab is an investigational humanized IgG4 mAb that blocks CCR5, a cellular receptor important for HIV infection, tumor metastases and other diseases including NASH (Nonalcoholic Steatohepatitis).
CytoDyn already completed two studies in COVID-19 patients (a phase II and a phase III) and is in the process of conducting an additional COVID-19 phase III study for mechanically-ventilated critically-ill COVID-19 patients.
The company successfully completed a phase III study evaluating leronlimab combined with standard antiretroviral therapies for HIV-infected treatment-experienced patients. The company is currently working on refiling its Biologics License Application (BLA) for this HIV combination therapy as it received a Refusal to File in July 2020. CytoDyn expects to resubmit its BLA in the first half of the year.
CytoDyn’s stock has lost 49.9% in the year so far compared with the industry's decline of 2.2%.
Most biotech/pharma companies are evaluating every weapon in their arsenal to combat and prevent the coronavirus spread and help the infected.
Kaleido Biosciences, Inc. reported positive results from a study on KB109 in patients with mild-to-moderate COVID-19. Results from a non-Investigational New Drug (IND) study of KB109 in these patients showed a reduction in overall COVID-19-related healthcare utilization comprising hospitalizations, emergency room visits and urgent care visits.
Regeneron’s (REGN - Free Report) investigational antibody cocktail for COVID-19 showed efficacy against the emerging variants. It was granted an Emergency Use Authorization in November 2020 for the treatment of mild-to-moderate COVID-19 in adults as well as pediatric patients who are at least 12 years old and weighing minimum 40 kg. Vir Biotechnology, Inc (VIR - Free Report) and partner GlaxoSmithKline plc submitted an application to the FDA requesting an Emergency Use Authorization (EUA) for their investigational dual-action SARS-CoV-2 monoclonal antibody VIR-7831 (GSK4182136).
CytoDyn currently carries a Zacks Rank #4 (Sell).
You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
More Stock News: This Is Bigger than the iPhone!
It could become the mother of all technological revolutions. Apple sold a mere 1 billion iPhones in 10 years but a new breakthrough is expected to generate more than 77 billion devices by 2025, creating a $1.3 trillion market.
Zacks has just released a Special Report that spotlights this fast-emerging phenomenon and 4 tickers for taking advantage of it. If you don't buy now, you may kick yourself in 2022.
Click here for the 4 trades >>