Takeda's once-weekly DPP-4 inhibitor moves into Phase III in Japan
This article was originally published in Scrip
Takeda has begun a Phase III clinical development programme in Japan with an oral DPP-4 inhibitor for type 2 diabetes that appears to be the most advanced in its class able to be dosed once a week rather than once-daily.
The molecule, SYR-472, was originally discovered by the US drug design venture Syrrx, which Takeda acquired in 2005 and now operates as Takeda San Diego. Phase II studies are underway in the US and EU, and previous disclosures have shown that SYR-472 is being investigated in various potential indications including in patients unresponsive to diet and exercise or this regimen plus metformin monotherapy.
Takeda has already commercialised its lead DPP-4 inhibitor alogliptin in Japan, which is marketed both as a monotherapy and in various fixed-dose and other combinations. But outside Japan, the drug has faced development delays due to a need for additional studies and has yet to be approved in the US and EU.
Alogliptin was recently resubmitted in the US for both monotherapy use and in fixed-dose combination with pioglitazone (Actos), following the complete response letters issued in 2009 (scripintelligence.com, 26 July 2011), and Phase III trials are underway in the EU.
Other new once-weekly therapies for diabetes are being developed, notably Amylin/Lilly/Alkermes' GLP-1 receptor agonist Bydureon (extended-release exenatide), which was approved in the EU in June, but these are injected. The standard release exenatide product Byetta was launched in Japan at the end of last year, and Lilly's local pipeline shows that the once-weekly form is awaiting approval in the country.
Ipsen's once-weekly injected GLP-1 receptor agonist taspoglutide has faced problems after pivotal trials were suspended around a year ago, due to gastrointestinal tolerability and hypersensitivity reactions. Former partner Roche has since returned rights, although Ipsen's Japanese partner Teijin Pharma noted in its first-quarter results in early August that the drug was still in local Phase II local trials (as ITM-077).