Intarcia's Novel Diabetes Treatment Succeeds In Two Late-Stage Trials
By C. Rajan, contributing writer
Intarcia Therapeutics has announced positive top-line results from two of its four ongoing phase 3 clinical trials for its long term type 2 diabetes treatment, ITCA 650 (exenatide, delivered via subcutaneous osmotic mini-pump).
"Our first phase 3 results are truly remarkable and they mark a major milestone for our company and for our mission to bring potential game-changing and life-enhancing therapies to patients, payors, and providers," said Kurt Graves, Chairman, President, and CEO of Intarcia.
The first Phase 3 trial, FREEDOM-1, tested the efficacy and safety of ITCA 650 in patients with type 2 diabetes. ITCA 650 proved to be significantly superior to placebo in bringing the patients’ blood glucose under control, while also meeting other established clinical endpoints.
The second trial, FREEDOM-1 HBL (High Baseline), enrolled patients with type 2 diabetes that had very high baseline blood glucose levels that could not be controlled with other therapies. ITCA 650 was able to lower the blood glucose threshold level in 25 percent of the patients and continued to reduce levels by 3.4 percent through the duration of the 9-month-long trial. “We now look forward to finishing the rest of our trials and working closely with global health authorities as we strive to prepare ITCA 650 for filing and registration, and then to make it available to patients and the broader healthcare system," Graves added.
In the other two Phase 3 trials, ITCA 650 is being evaluated against Merck’s blockbuster diabetes drug, Januvia, as well as undergoing tests for cardiovascular safety.
ITCA 650 is a reformulation of exenatide, a glucagon-like peptide-1 (GLP-1) receptor agonist. Exenatide is the active ingredient in currently available type 2 diabetes therapies, such as AstraZeneca’s Bydureon, which are injected twice daily or once a week.
In ITCA 650, exenatide is delivered continuously once or twice a year through a small, thin (“matchstick-sized”) miniature osmotic pump, which is placed under the skin of the abdomen. Moreover, the company’s novel reformulated version of exenatide is designed to be stable at human body temperatures for long periods of time.
ITCA 650 is Intarcia’s main drug, which is currently being evaluated in about 5,000 patients through the four Phase 3 trials. The small privately-held Boston-based biotech firm secured $200 million in private funding in April, but is otherwise working without Big Pharma partnerships, the Boston Business Journal reports.
If approved, the ITCA 650 drug-device treatment system will be the first of its kind, and the only injection-free GLP-1 therapy for type 2 diabetes capable of delivering up to a full year of treatment in a single device. The company is developing both the once yearly and twice yearly mini-pumps in the ongoing studies as well as for the additional phase 3B studies planned for next year.
Should the once-or-twice-yearly drug receive approval, it would enter the diabetes treatment rink with an advantage over current blockbuster GLP-1 therapies, such as Merck’s Januvia or Novo Nordisk's blockbuster Victoza, which require daily or weekly injections to manage diabetes. According to the Boston Business Journal. Victoza earned about $1.1 billion while Januvia earned $2.8 billion in the U.S. last year.