Isis starts phase 2 study of ISIS-FXIRx drug

Earlier this year, Isis signed a license agreement with Bayer HealthCare for the development and commercialization of ISIS-FXIRx to prevent clotting disorders.

Upon completion of ongoing activities at Isis, Bayer will assume global clinical development as well as worldwide regulatory and commercialization responsibilities for the drug.

Bayer aims to assess the therapeutic profile of ISIS-FXIRx in patients for whom currently available anticoagulants may not be used, such as in patients with a high risk of bleeding due to multiple co-morbidities.

Isis will be eligible to receive a $55m payment after completion of the study and advancement of the program.

ISIS-FXIRx is designed to inhibit the production of Factor XI, a coagulation factor produced in the liver that is involved in the propagation of clots.

The first patient has already been dosed in the randomized, double-blind, placebo controlled phase 2 study. The drug will be administered to about 50 patients with ESRD on hemodialysis.

It will evaluate the safety, pharmacokinetic and pharmacodynamic effects of weekly dosing of 200mg or 300mg ISIS-FXIRx for up to 12 weeks.

Isis Pharmaceuticals COO Lynne Parshall said: "ISIS-FXIRx 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.

"This Phase 2 study furthers both our and Bayer’s goal of initially providing ISIS-FXIRx to patients with high unmet need.

"These data will support Bayer’s plans for a robust development program to optimize the clinical potential of this drug."