Intarcia Therapeutics recently released results from the Freedom-2 trial of its ITCA 650 investigational candidate injection-free GLP-1 receptor agonist delivered with its Medici drug delivery system, touting fulfilled primary and secondary endpoints.
The Medici system is comprised of a matchstick-sized osmotic minipump placed just under the skin to deliver medication, a placement system for implantation and stabilization technology designed for proteins, peptides, antibody fragments and other high-potency small molecules.
“The efficacy demonstrated by ITCA 650 in this trial has significant potential for many type 2 diabetes patients who need better glycemic control and are often non-compliant with their daily or weekly medications. Key barriers to achieving and sustaining glycemic targets in type 2 diabetes have been related to sub-optimal efficacy of some medicines, poor adherence and the lack of persistence with therapy over time – whether pills or injections. An innovative treatment like ITCA 650 may soon provide the type 2 diabetes community with a critical new tool that can ensure treatment compliance for periods of six months, and eventually up to one year, to help many patients reach and sustain their individual glycemic goals,” lead investigator Dr. Julio Rosenstock of the Dallas Diabetes and Endocrine Center at Medical City said in a press release.
Data from the trial reported that the ITCA 650 demonstrated superior efficacy when compared to Januvia in reducing HbA1c and body weight in patients on metformin with poorly controlled type 2 diabetes after 1 year of treatment, the company said. Data also indicated greater reductions in HbA1c with ITCA 650 and weight across the entirety of the trial.
“The impressive results with ITCA 650 in this 52-week, head-to-head trial against Januvia, currently the largest selling oral therapy, demonstrate that ITCA 650 can be an important new treatment option for early use with metformin. Injectable GLP-1 receptor agonists aren’t typically used early in treatment with Metformin because patients and doctors tend to reserve the choice of life-long injections until other options fail. If approved, ITCA 650 given just once or twice-yearly, can provide patients and doctors with a totally new way to deliver GLP-1 therapy much earlier with metformin,” CEO Kurt Graves, Chairman said in prepared remarks.