The US Food and Drug Administration (FDA) has placed a complete clinical hold on Cytodyn’s Covid-19 programme in the country.
With the full clinical hold in place, the company will not launch any new clinical trials until the regulatory agency lifts the hold.
At present, CytoDyn is not carrying out any Covid-19 trials in the US, as the company is analysing the most ideal programmes to invest its resources and focus.
A clinical stage biotechnology company, CytoDyn is analysing its leronlimab, an investigational humanised IgG4 monoclonal antibody, for its potential in various treatment areas, including infectious disease, cancer and autoimmune conditions.
The FDA has also placed a partial hold on CytoDyn’s HIV programme.
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The company was not enrolling new subjects in the trials under clinical hold in the US.
The partial clinical hold placed on the HIV programme will affect the subjects who are presently enrolled in extension trials.
CytoDyn intends to transition these participants to other available therapies as it cannot commence or resume trials until the FDA lifts the partial clinical hold.
In addition, the company will hold talks with the regulatory authority to resolve the partial clinical hold.
Furthermore, the company decided to halt the Covid-19 trials in Brazil pending data from the data safety monitoring committee meeting and is currently re-assessing the timing to submit the biologics licence application (BLA) for the HIV programme.
CytoDyn chief medical officer Scott Kelly said: “CytoDyn is committed to FDA compliance.
“We are evaluating our clinical programmes and are working to resolve the issues underlying the clinical holds as soon as possible in close communication with the FDA.”
In May last year, the company announced plans to submit the data from the Phase III CD12 trial of Vyrologix (leronlimab-PRO 140) to seek regulatory approval for the drug for the treatment of severe to critically ill Covid-19 patients.
