CombinatoRx, Incorporated reported positive results for its phase-2 clinical study of CRx-401 as an add-on to metformin therapy in type-2 diabetes. Results from this trial demonstrated that CRx-401 (a synergistic combination of bezafibrate and diflunisal) performed statistically significantly better than bezafibrate on the primary efficacy endpoint of reduction in fasting plasma glucose (FPG) at day 90 with a difference of 12 mg/dL (p=0.049).
Consistent trends were observed in favour of CRx-401 on other supportive efficacy endpoints including glucose control, with reductions in HbA1c and homeostasis model assessment of insulin resistance (HOMA-IR), and inflammatory control, with a reduction in C-reactive protein (CRP), providing a favourable overall impact on the treatment of subjects with type-2 diabetes. In addition, CRx-401 treatment was associated with an expected reduction in serum triglyceride levels, consistent with the benefit of bezafibrate therapy.
"We are encouraged to see that CRx-401 achieved statistically significant and clinically relevant reductions in FPG and a positive trend in other efficacy measures including HOMA-IR," commented Alexis Borisy, president and CEO of CombinatoRx. "CRx-401 demonstrated an ability to control glucose, lipids and inflammation, presenting a beneficial overall profile with the potential for the treatment of type-2 diabetes and its associated co-morbidities. The positive anti-diabetic efficacy results observed with CRx-401, coupled with a good safety and tolerability profile, supports additional evaluation of CRx-401 in the treatment of type 2 diabetes."
The CRx-401 study enrolled 120 subjects with moderate to severe diabetes and was designed to demonstrate the synergistic anti-diabetic activity of CRx-401 compared to bezafibrate as an add-on to metformin therapy in subjects with poorly controlled diabetes. CRx-401 and bezafibrate were well-tolerated and there were no study drug-related serious adverse events reported. The most commonly reported adverse events were dizziness and nausea, with the latter reported less frequently for the combination therapy vs. bezafibrate alone. Full analysis of the clinical data, including genetic biomarker results are planned to be submitted for presentation at an appropriate scientific conference.
CRx-401 is a novel insulin sensitizer designed to provide anti-diabetic activity without promoting weight gain.
CombinatoRx, Incorporated (CRXX) is pioneering the new field of synergistic combination pharmaceuticals. Going beyond traditional combinations, CombinatoRx creates product candidates with novel mechanisms of action, striking at the biological complexities of human disease.