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news.TWi Pharmaceuticals has completed Phase IIb clinical trial of AC-201 in 259 patients with Type 2 diabetes with uncontrolled on up to three oral medications.
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AC-201 is an orally available small molecule in development which modulates the intracellular synthesis of the cytokine IL-1Beta.
TWi Pharmaceuticals acting president Calvin Chih-Kuang Chen said, "We are pleased to see AC-201 once again demonstrated a good potential to be a treatment for patients with type II diabetes; the data from patients in the US are especially encouraging."
In the intent-to-treat population, AC-201 demonstrated placebo-corrected reductions in HbA1c of 0.20%, 0.29%, and 0.35%*(* indicates statistical significance with p<0.05) after 24 weeks of treatment in the three tested dose groups of 25mg, 50mg, and 75mg twice daily (b.i.d), respectively.
In the per-protocol population, the placebo-corrected reduction in HbA1c was 0.37%, 0.42%*, and 0.49%*, for 25mg, 50mg, and 75mg b.i.d dose groups, respectively.
In the study, AC-201 showed good dose response and was well tolerated up to 75mg b.i.d, diarrhoea was the most frequent side effect mostly observed, according to the company.