| 2016-11-20 14:26:19|
KDMN 14:26 11/20 11/20/16
Kadmon reports new data on tesevatinib in kidney cyst patients
Kadmon announced additional data from its ongoing Phase 2a clinical study demonstrating the safety of tesevatinib for the treatment of autosomal dominant polycystic kidney disease. The data will be presented at the American Society of Nephrology Kidney Week. "Recent findings from Kadmon's ongoing Phase 2a study in patients with ADPKD have demonstrated that tesevatinib is well tolerated and have also identified tesevatinib 50 mg once daily as the optimal dose to treat ADPKD. New data reported in the poster indicate that tesevatinib is a new member of a group of drugs known as MATE 1/2-K transporter inhibitors, such as cimetidine, which mildly increase levels of serum creatinine. Normally, an increase in serum creatinine can be used to indicate kidney damage, but in the case of MATE 1/2-K inhibitors, these serum creatinine increases occur without clinically meaningful alterations in renal function. Specifically, new data demonstrated that serum creatinine levels in tesevatinib patients increased by 10%-14% during the first 28 days of treatment and reversed upon treatment discontinuation. Importantly, levels of cystatin C, another measure of renal function, were relatively unchanged during the same period. In vitro studies demonstrated that tesevatinib potently inhibits MATE1/2-K transporters at tesevatinib concentrations achieved with the 50 mg QD dose. Therefore, MATE inhibition by tesevatinib may explain mild serum creatinine increases associated with tesevatinib treatment," the company reported. "Kadmon has had discussions with the FDA to develop innovative methods to demonstrate drug safety and efficacy in PKD, a major unmet medical need. These discussions will have important implications for clinical trial designs for tesevatinib as well as other therapies in development for renal diseases, especially MATE inhibitors," noted CMO John Ryan.