Biotech CytoDyn (CYDY) has announced that an independent Data Safety Monitoring Committee (“DSMC”) completed its first safety review of the ongoing Phase 3 clinical trial (CD12) in patients with severe and critical COVID-19 and reported it saw no cause to modify the study.
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The DSMC reviewed compiled safety data from 149 subjects enrolled in the CD12 trial. The DSMC did not raise any concerns regarding safety and recommended that the trial continue.
The Phase 3 study currently has 169 enrolled patients and CYDY says it will conduct a full interim analysis once 195 patients are enrolled, as provided in the trial’s protocol.
Nader Pourhassan, CEO of CytoDyn, stated, “We are grateful to be less than 30 patients away from our planned interim analysis enrollment goal, and we look forward to sharing those interim efficacy results as soon as possible.”
Meanwhile Jacob Lalezari, CytoDyn’s Chief Science Advisor, added, “We are very pleased the DSMC reported no safety concerns in CD12, a population with very severe illness and comorbidities at study entry.”
CD12 is a Phase 3 randomized, double blind, placebo controlled, adaptive design multicenter two arm study to evaluate the safety and efficacy of leronlimab in patients with severe or critical symptoms of respiratory illness caused by coronavirus 2019 infection.
Patients are randomized 2:1 (two leronlimab: one placebo) to receive weekly doses of 700 mg leronlimab or placebo via subcutaneous injection. The study has three phases: Screening Period, Treatment Period and Follow-Up Period. The primary outcome measured by this study is: all-cause mortality at Day 28. Secondary outcomes measured are: (1) all-cause mortality at Day 14, (2) change in clinical status of subject at Day 14, (3) change in clinical status of subject at Day 28, and (4) change from baseline in Sequential Organ Failure Assessment (SOFA) score at Day 14.
CytoDyn has already completed its Phase 2 clinical trial (CD10) for COVID-19, a randomized clinical trial for mild-to-moderate patients in the U.S. and is currently evaluating the data.
Leronlimab is an investigational humanized IgG4 mAb that blocks CCR5, a cellular receptor that is important in HIV infection, tumor metastases, and other diseases, including NASH. Leronlimab has completed nine clinical trials in over 800 people and met its primary endpoints in a pivotal Phase 3 trial (leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients).
Indeed, the FDA has granted a Fast Track designation to CytoDyn for two potential indications of leronlimab for critical illnesses- HAART for HIV-infected patients and for metastatic triple-negative breast cancer.
Shares in CYDY are currently trading up a whopping 400% year-to-date- however analyst Yi Chen of HC Wainwright is staying sidelined on the stock for now. “Leronlimab shows a better safety profile than placebo in mild-to-moderate COVID-19 patients” Chen commented on July 22,
The analyst told investors: “The data also bode well for the Phase 2b/3 trial of leronlimab in severely ill COVID-19 patients, for which a progress update could occur in the coming weeks. Looking forward to further clinical data—including evidence of efficacy—in COVID-19 patients, we reiterate our Neutral rating without a price target.” (See CytoDyn stock analysis on TipRanks).
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