PledPharma AB (STO: PLED), an integrated pharmaceutical drug development company, announced on Thursday that the US Food and Drug Administration (FDA) has issued a clinical hold in the US of the phase III POLAR programme for its lead candidate PledOx.

As a result of this, the recruitment and dosing of patients in the POLAR-M study is halted in the US. Reportedly, this decision by the FDA is due to safety reasons based on a few numbers of observed adverse events.

According to the company, based on the evaluation of the independent Drug Safety Monitoring Board (DSMB), the overall safety profile for PledOx supports the continuation of the POLAR programme and both studies will continue as planned in Europe and Asia.

The global phase III POLAR programme for PledOx consists of two double blinded randomised placebo-controlled trials, POLAR-A and POLAR-M. POLAR-A is conducted in Europe and Asia in patients undergoing adjuvant chemotherapy treatment for colorectal cancer and was fully recruited in December 2019. POLAR-M is conducted in Europe, Asia and the US in patients undergoing chemotherapy treatment for metastatic colorectal cancer, where recruitment is ongoing.

With this clinical hold of the POLAR programme issued by the FDA, patients currently enrolled in the US will continue with their scheduled study visits and procedures, except for the dosing of study drug. Both POLAR studies will continue as planned in Europe and Asia.

PledPharma added that it will continue to work with the FDA to provide the necessary information to lift the clinical hold as soon as possible. Also, other regulatory authorities involved in the POLAR programme will be informed about the US clinical hold.