Ark Therapeutics has announced plans to conduct a pilot late-stage trial of Vitor, its candidate for treating weight loss and muscle-wasting associated with cancer, to help confirm the design of the full Phase III study necessary for US approval.
Under the Special Protocol Assessment process, the company has agreed with the US Food and Drug Administration that it should carry out a small pilot study in 60 patients to determine the best endpoints for assessing the drug’s potential.
This trial is due to start immediately and is expected to take around nine months, but should ultimately result in a faster review process on completion of the clinical programme, the firm said.
“The FDA’s requirements for relevant clinical endpoints and safety data in Phase III studies have become increasingly rigorous, and the SPA process has been extremely useful in understanding exactly what is required for approval before incurring the expenditure and time associated with a full Phase III trial,” commented Nigel Parker, Ark’s chief executive.
“In this environment, it is appropriate, even for products like Vitor which has been awarded Fast Track designation, to be adopting a careful approach to ensure that there are no outstanding trial design or endpoint issues which might prevent an approval in the future,” he added.