Takeda Pharmaceutical Co has presented positive late-stage data on a new diabetes compound called fasiglifam.
The company announced results of a Phase III trial at the Japan Diabetes Society meeting in Kumamoto, which show that 25mg and 50mg oral fasiglifam, when administered once-daily, showed statistically significant and clinically relevant HbA1c lowering effect in type 2 diabetes patients. Takeda said the drug is the first GPR40 agonist to reach late-stage development.
In the 192-patient trial, the percentage whose HbA1c levels were reduced to the glycaemic target of under 6.9% in the fasiglifam 25mg and 50mg doses were 30.2% and 54.8%, respectively, compared with 13.8% for patients on placebo. Treatment-emerging adverse events were mild to moderate for the patients who were all Japanese, with no significant differences between the fasiglifam groups and placebo.
Kohei Kaku, professor of Kawasaki Medical School who made the presentation at JDS, said that "if approved, fasiglifam has the potential to become an important new treatment option for diabetics". He noted that "it is a novel glucose dependent insulin secretagogue with low risk of hypoglycaemia".
Takeda's diabetes franchise has been hit hard by a decline in sales of off-patent Actos (pioglitazone), although the company is hoping that the decline will be offset by its recently-approved Nesina (alogliptin) as well as a fixed-dose combination of the latter and Actos, marketed in the USA as Oseni.