Taiwan-based TWi Pharmaceuticals has announced positive results from a Phase IIb dose-ranging study of AC-201 in 259 uncontrolled type II diabetes patients on up to three oral medications.
AC-201 is an orally-available small molecule that 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% (0.35% shows a statistical significance with p<0.05) after 24 weeks of treatment in the three tested dose groups of 25mg, 50mg, and 75mg twice daily (BID), respectively.
In the per-protocol population, the placebo-corrected reduction in HbA1c was 0.37%, 0.42%, and 0.49% (0.42% and 0.49% show statistical significance with p<0.05), for 25mg, 50mg, and 75mg BID dose groups, respectively.
Fu Jen Catholic University professor of medicine and Cardinal Tien Hospital, Taipei, chief of internal medicine Dr Dee Pei said AC-201 has the ability to reduce HbA1c levels in difficult-to-treat patients.
"AC-201 could be a very useful tool when combinations of drugs are required to achieve successful control of blood sugar in certain type II diabetic patients," Dr. Pei added.
In the study, AC-201 showed good dose response and was well tolerated up to 75mg BID. According to the company, diarrhoea was the most frequently observed side effect.
The trial was conducted in the US, where 150 patients were enrolled in 13 sites, and Taiwan, where 109 patients were enrolled in eight sites.