Kadmon Corporation Initiates Second Phase 2 Clinical Trial Evaluating KD026 In Type 2 Diabetes

NEW YORK, NY--(Marketwired - May 04, 2015) - Kadmon Corporation, LLC, today announced that the first patient has been dosed in the Company’s second Phase 2 clinical trial (Study KD026-201) evaluating the safety, tolerability and efficacy of KD026, the Company’s inhibitor of microsomal triglyceride transfer protein (MTP), in combination with metformin in patients with Type 2 diabetes mellitus. The randomized, double-blind, placebo-controlled study examines KD026 administered at doses of 100 mg, 150 mg or 200 mg twice daily (BID) or 100 mg three times daily (TID) for three months in 120 patients at ten sites in the United States.

KD026 is a potent and selective MTP inhibitor targeted to intestinal enterocytes, with less than one percent systemic distribution in humans, avoiding toxicities observed with first-generation MTP inhibitors. In the previous Phase 2 clinical study in patients with Type 2 diabetes, KD026 dosed at 100 mg BID demonstrated no clinically significant adverse events and a statistically significant decrease in HbA1c at 12 weeks. Additional benefits seen among patients were lowered plasma glucose, lowered LDL-C, lowered post-prandial lipids, and weight loss.

“Previous clinical studies have shown that KD026 lowers HbA1c and that its activity is restricted to the gastrointestinal system, offering potential safety and tolerability advantages over currently available therapies,” said John L. Ryan, Ph.D., M.D., Executive Vice President and Chief Medical Officer at Kadmon. “We believe this second Phase 2 study assessing KD026 at higher doses will identify optimal dosing and support its use in combination with metformin as well as other drugs used as treatment modalities for Type 2 diabetes.”

About Kadmon Corporation
Kadmon Corporation, LLC, is a vertically 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, monogenic diseases 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.