FDA places two clinical holds on CytoDyn HIV and COVID-19 programmes
pharmafile | April 1, 2022 | News story | Medical Communications |
The FDA has placed a partial hold on CytoDyn’s HIV program, and a full clinical hold on its COVID-19 program in the US.
The company also decided to pause its COVID-19 trials in Brazil until after an analysis by an independent Data Monitoring Committee. CytoDyn has not revealed the reasons behind the clinical holds.
In May 2021, the FDA accused CytoDyn of misrepresenting clinical trial data of leronlimab for COVID-19. The statement focused on data from two clinical trials, CD10, in 86 mild-to-moderate COVID-19 patients, and CD12, in 394 patients with severe symptoms.
The company’s Phase III trial in March 2021 failed to meet the primary endpoint of reducing symptoms, and missed all secondary endpoints, including if the drug decreased mortality for COVID-19. However, CytoDyn focused on a subgroup of 62 patients on mechanical ventilation, stating that the drug resulted in a 24% decrease in all-cause mortality, and a six-day reduction in hospitalisation.
At the time, the FDA stated, “It has become clear that the data currently available do not support the clinical benefit of leronlimab for the treatment of COVID-19. None of these analyses met statistical significance when using established and reliable analytical methods that correct for multiple comparisons.”
The partial clinical hold on CytoDyn’s HIV programme affects patients enrolled in extension studies. The company indicated that these patients will be transitioned to other therapeutics, and no clinical trials can be launched or resumed until the partial hold is lifted.
The full clinical on the COVID-19 program prevents any new studies from being initiated. As it stands, it isn’t running any COVID-19 trials in the US and is now “evaluating the most optimal programs on which to focus its resources and attention.”
Lina Adams
