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news.US-based biopharmaceutical firm Kadmon has started dosing in its second Phase II clinical trial (Study KD026-201) of its inhibitor of microsomal triglyceride transfer protein (MTP), KD026, in combination with metformin to treat patients with type 2 diabetes mellitus.
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Around 120 patients at ten sites in the US will be included in the randomized, double-blind, placebo-controlled trial, which will evaluate the safety, tolerability and efficacy of KD026 administered at doses of 100mg, 150mg or 200mg twice daily (BID) or 100mg three times daily (TID) for three months.
KD026 is targeted to intestinal enterocytes, with less than one percent systemic distribution in humans, avoiding toxicities observed with first-generation MTP inhibitors.
The company said that in the previous Phase II trial conducted in patients with type 2 diabetes, KD026 dosed at 100mg BID demonstrated no clinically significant adverse events and a statistically significant decrease in HbA1c at 12 weeks.
Kadmon executive vice-president and chief medical officer Dr John Ryan said: "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.
"We believe this second Phase II 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."