Isis begins Phase II trial of ISIS-FXI to treat ESRD

US-based Isis Pharmaceuticals has started a Phase II trial of ISIS-FXI, an antisense drug for end-stage renal disease (ESRD) patients on haemodialysis.

In May, the company entered into an exclusive licence agreement with Bayer HealthCare to develop and commercialise ISIS-FXI for the prevention of clotting disorders.

The Phase II trial is intended to further characterise the profile of ISIS-FXI, and will provide essential data for Bayer’s future clinical development programme.

Following the completion of Phase II and Bayer’s advancement of the programme, Isis will be eligible to receive a $55m payment.

ISIS-FXI is designed to reduce liver production of Factor XI, a coagulation factor involved in the propagation of clots.

Isis Pharmaceuticals chief operating officer Lynne Parshall said: "ESRD patients receiving chronic dialysis are prone to increased thrombosis. However, antithrombotic treatment options for these patients remain limited because these patients also have a high risk of bleeding.

"ISIS-FXI is a first-in-class antisense drug in clinical development that has shown a significant reduction in clotting, without increasing bleeding events in previous clinical studies.

"Data will support Bayer’s plans for a robust development programme to optimise the clinical potential of this drug."

In the randomised, double-blind, placebo-controlled Phase II trial, ISIS-FXI will be administered to about 50 ESRD patients on hemodialysis.

Dosing has already begun in the trial, which is designed to evaluate the safety, pharmacokinetic and pharmacodynamic effects of weekly 200mg / 300mg doses for up to 12 weeks.

Under the clinical development programme, Bayer intends to evaluate the therapeutic profile of ISIS-FXI in patients resistant to current anticoagulants, such as those with a high risk of bleeding due to multiple co-morbidities.