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Ark Therapeutics completes potency test qualification enabling Trinam Phase III trial to begin - Quick Facts

Ark Therapeutics Group plc.(AKT.L) announced that it has successfully completed the work requested by the US Food and Drug Administrationto qualify a potency test for Trinam. As a result, the FDA has now notified the Company that it can commence patient recruitment into its Trinam Phase III trial.

Trinam is Ark's novel gene-based medicine to prevent blood vessels blocking in kidney dialysis patients who have undergone vascular access graft surgery.

The Phase III study is a US multi-centre, randomised, controlled trial, in which the efficacy and safety of Trinam will be investigated in patients with end-stage renal disease (ESRD) requiring vascular access for haemodialysis.

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