SOURCE: Kadmon Corporation

Kadmon Corporation

November 02, 2015 08:30 ET

Kadmon Corporation to Present Clinical Data on Tesevatinib for the Treatment of Polycystic Kidney Disease at ASN's Kidney Week 2015

Phase 1b/2a Study Being Expanded; Planned Registration Study to Follow

NEW YORK, NY--(Marketwired - Nov 2, 2015) - Kadmon Corporation, LLC today announced data from an ongoing Phase 1b/2a clinical trial demonstrating the tolerability of tesevatinib, the Company's investigational oral tyrosine kinase inhibitor, in patients with autosomal dominant polycystic kidney disease (ADPKD). The data will be presented in a poster session (SA-PO865) at the American Society of Nephrology (ASN) Kidney Week 2015, being held November 3-8, 2015 in San Diego, CA. 

ADPKD is an inherited disorder characterized by the formation of fluid-filled renal cysts, leading to loss of kidney function and end-stage renal disease. Tesevatinib inhibits the molecular pathways central to the progression of ADPKD, namely EGFR and Src family kinases. In addition, tesevatinib accumulates in the kidneys, 15-fold greater than in blood, making it an excellent potential therapeutic product candidate for PKD. 

The Phase 1b portion of the study demonstrated that tesevatinib was generally well tolerated at 50, 100 and 150 mg QD, with rash occurring in the 150 mg QD dose cohort. The Phase 2a portion of the study evaluated tesevatinib 150 mg administered twice or three times weekly. The tolerability of these intermittent dosing schedules was improved over 150 mg QD, but rash still occurred. In order to better characterize the safety profile of tesevatinib, an additional 20 patients dosed at 50 mg QD are being enrolled into the study. 

"We believe that tesevatinib's accumulation in the kidneys and specific inhibition of EGFR and Src allow for lower dosage in ADPKD patients, making it potentially suitable for long-term use with reduced adverse events," said Mark S. Berger, M.D., Senior Vice President, Clinical Research at Kadmon. "Results from this ongoing study have indicated that tesevatinib 50 mg QD appears to be an optimal dose to treat ADPKD."

"Tesevatinib is ideally suited to treat ADPKD, a disease for which there are no FDA-approved therapies," said Harlan W. Waksal, M.D., President and CEO at Kadmon. "Since ADPKD is a chronic disease requiring lifelong treatment, we will confirm the safety profile of tesevatinib at the 50 mg QD dose before pursuing a potential registration study in this indication."

In addition to ADPKD, Kadmon is developing tesevatinib for the treatment of autosomal recessive PKD (ARPKD), a rare but more severe form of the disease affecting newborns. The Company plans to initiate a Phase 1b/2a clinical trial of tesevatinib in ARPKD in 2016. 

About Kadmon Corporation
Kadmon Corporation, LLC is a fully integrated biopharmaceutical company focused on developing innovative products for significant unmet medical needs. We have a diversified product pipeline in autoimmune and fibrotic diseases, oncology, genetic and metabolic disease. For more information, visit www.kadmon.com.

This press release contains forward-looking statements. These forward-looking statements are based on management's expectations and are subject to certain factors, risks and uncertainties that may cause actual results, outcome of events, timing and performance to differ materially from those expressed or implied by such statements. The information contained in this press release is believed to be current as of the date of original issue. Kadmon expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.

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