Exelixis initiates phase II kidney disease trial

The phase II trial is designed to enroll approximately 130 patients with diabetes who have clinically significant protein in the urine (proteinuria). Participants will be randomly assigned to receive 200mg of XL784 or placebo daily for three months.

The primary endpoint is reduction in proteinuria, and secondary endpoints will evaluate changes in renal function and cardiovascular effects.

XL784 is a potent small molecule inhibitor of the ADAM-10 metalloprotease enzyme, which plays a role in blood vessel formation and cell proliferation that can cause renal fibrosis and impairment.

“XL784 is our first product candidate to address an indication outside oncology. Data from preclinical studies indicated that XL784 has the potential to provide a substantial improvement in the treatment of renal disease, and we are excited about the clinical potential of this novel compound,” said Dr George Scangos, president and CEO of Exelixis.

Two phase I studies of XL784 have already been completed in healthy volunteers and both studies demonstrated that the compound is orally bioavailable, shows dose-proportional exposure and has an approximate 8 hour half-life.