Promising revolution, Intarcia’s diabetes device poised for filing

Intarcia Therapeutics is primed to file its potentially revolutionary diabetes drug delivery device after revealing positive cardiovascular safety results.

ITCA 650 is a subcutaneous, matchstick-sized implant that continuously delivers the glucagon-like peptide-1 (GLP-1) agonist exenatide (AstraZeneca’s Byetta), and could radically alter treatment of diabetes.

The device represents a new and convenient alternative to injections and daily pills. In contrast to these existing delivery methods, ITCA 650 only needs to be implanted just under the skin once or twice a year.

The Boston, Massachusets company has just unveiled the fourth and final part of its FREEDOM Phase 3 Clinical Trial programme, which involved a total of 4,000 patients already on a variety of approved anti-diabetes therapies.  The study showed the device to be non-inferior to existing delivery methods in terms of cardiovascular safety.

Having now passed the final stage of phase 3 testing, Intarcia is now poised to file the device with the FDA at the end of Q3. It is also preparing its manufacturing data packages, and investing $75 million in manufacturing through a new debt financing.

Kurt Graves, chairman, president and CEO of Intarcia Therapeutics commented on the results: “The FREEDOM Phase 3 clinical trial programme for ITCA 650 has come to a close at an exciting and auspicious time in the GLP-1 receptor agonist category: A time when our global phase 3 programme has successfully completed, and a time when new medical evidence from larger and longer-term trials is just emerging showing that GLP-1 receptor agonists may provide potential cardiovascular benefit to patients.”

ITCA 650 is implanted under the skin and ensures a constant delivery of exenatide.

“[It is] a totally differentiated approach for chronic medicine delivery that we aim to show can bring important potential benefits to patients, payers and providers who seek earlier and better control of type 2 diabetes, dramatically improved medication adherence and control rates over time, and an important alternative to life-long self-injections of GLP-1s and pills that the vast majority of patients with diabetes struggle to persist with after just six months of initiating therapy,” added Graves.

Intarcia is grabbing the attention of diabetes market leaders Novo Nordisk, Sanofi, Lilly and (existing collaborators) AstraZeneca, and could pose a major threat to top selling injectable and oral drugs.

In August last year it proved its value by beating Merck’s oral diabetes treatment Januvia in a phase 3 head-to-head trial, producing lower blood sugar levels and weight loss.

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