Treatment of diabetes hasn’t changed so much since the development of first human insulin by Genentech. But Boston-based Intarcia (a partner of Servier and one of the 9 billion-dollar Biotech startups worldwide) has just published positive phase III results of its implantable device aiming at changing how type 2 diabetes are treated.
November 2014: I thought I could have misread the realease, but to my surprise it’s true: France’s biggest private Pharma company has made a $1Bn partnership with a company called Intarcia. 1 Billion seemed an astronomical amount at the time, but since understanding more of what the deal entails, the scale of the partnership is more understandable.
Intarcia presented the results of its two first Phase III results at the 51st European Association for the Study of Diabetes in Stockholm, Sweden.
The trial, called FREEDOM (pretty original title for a trial, ay?), is investigating the efficacy of the active agent ITCA-650 for the treatment of type 2 diabetes. It is a combination of Intarcia’s own sub-dermal pump technology with a stabilized version of a glucagon-like peptide-1 (GLP-1) receptor agonist. This GLP-1 agonist is already on the market, but only as a self-injection, so the stabilization of the agonist permits use of the sub-dermal pump as an enhanced administration of the drug.
Intarcia’s press release contains lots of details on the results which would not be very useful to you…
So to summarize: Both clinical trials hold primary and secondary endpoints, reducing the HbA1c level and resulting in significant weight loss. These results are already linked to the GLP-1 protein injection, showing that the ITCA-650 product provides a stabilization role.
More importantly, Intarcia was able to show that the implant was completely safe. Any effects associated with the administration procedure to place and remove the ITCA-650 were generally “mild and transient”, and only a very low single digit of patients has to stop the 39-week study because of such problems (e.g. discomfort).
These two clinical trials shows the whole potential of this new generation of implant to treat type 2 diabetes. As James Gavin, the former president of the American Diabetes Association puts it:
“These [successful clinical trials] makes me optimistic that a totally new therapeutic approach is on the near-term horizon – one capable of delivering very significant progress against major unmet needs in type 2 diabetes around the world”.
Intarcia now has to submit approval to the FDA and the EMA. The billion-dollar startup will also receive milestone payments from its partner Servier.
Ultimately, if approved, the implant would represent the first injection-free GLP-1 therapy capable of delivering up to a full year of treatment from a single device – a game-changing device for the 382 million diabetes in the World.