Dive Brief:
- Intarcia Therapeutics has developed a once-a-year diabetes therapy—ITCA-650 for hard-to-treat patients.
- Data from a phase III trial evaluating use of ITCA-650 in patients with very high glycosolated hemoglobin (A1C) levels at baseline showed significant A1C reductions after treatment.
- ITCA-650 is being developed to help patients gain control of poorly controlled diabetes, but not to replace other therapies.
Dive Insight:
The ADA recommends that people with diabetes achieve a target A1C level of 7% or lower, yet 21% of people with diabetes have a level of 9% or higher. Because A1C levels represent blood glucose levels over time, this bodes poorly for long-term outcomes, meaning increased risk for developing end-stage renal disease, neuropathy potentially leading to amputation and blindness.
In an open-label, phase III, 6-month trial, average A1C reductions in ITCA-650—treated patients with baseline levels of 10-12% were -3.2%. Many of these patients were taking up to three oral antidiabetic medication per day. Responses have been positive.