Biopharmaceutical company Intarcia Therapeutics’ novel sub-dermal pump ITCA 650 has significantly outperformed Januvia in phase III trials.
ITCA 650 is matchstick-sized pump currently marketed as a twice daily or once weekly injection and, if approved, would be the first diabetic treatment capable of delivering up to a whole year’s treatment from a single subdermal osmotic pump.
The trials, known as FREEDOM, pitted ITCA 650 – whose active ingredient is exanatide (sold by AstraZeneca as the once-daily Byetta and once-weekly Bydureon), against Januvia (sitagliptin) in 535 patients over 52 weeks.
They found that the continual delivery system of the pump lowered HbA1c levels more, and also led to greater weight reduction of 4kg compared to Januvia’s 1.3kg.
Kurt Graves, chairman, president and CEO of Intarcia, said: “The comparative results on all study endpoints for ITCA 650 vs. Januvia were unambiguous and compelling.
“Add to that our planned once or twice-yearly dosing [could be] a very important and new delivery alternative to daily pills and life-long self-injections that many patients have difficulty adhering to after just 3-6 months.”
The release of the trial data has led to the release of an additional $100m from investors and Intarcia is now planning to file for FDA approval in early 2016.
Merck’s Januvia, which achieved global sales of $6bn last year, therefore may face stiff competition in the future as different treatment avenues open up. Confidence in Januvia however was recently boosted as concerns about its effect on cardiovascular health were allayed.
In the UK there are currently more than three million people suffering from diabetes with the figure expected to rise dramatically to five million by 2025.
Founded in 1995, Intarcia Therapeutics is a Boston-based biopharmaceutical company that has been engaged in the development of a once-a-year diabetes treatment since 2012.
The results of the trial will please French pharma company Servier, which at the end of 2014 licensed the rights to the mini-pump in a deal worth up to $1bn.
Servier had previously said that the pump could be implanted by a qualified physician in five minutes and could also “reshape” the treatment of diabetes.