Kadmon Corporation, LLC, a vertically integrated biopharmaceutical company, announced that the first patient has been dosed in its second phase 2 clinical trial (Study KD026-201) evaluating the safety, tolerability and efficacy of KD026, 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, 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.”
Kadmon Corporation, LLC, is a vertically integrated biopharmaceutical company focused on developing innovative products for significant unmet medical needs.