Isis Pharmaceuticals, Inc. recently announced the outcome of their Phase 2 study of ISIS-PTP1BRx in patients suffering from type 2 diabetes. Patients treated with ISIS-PTP1BRx manifested statistically significant reductions in hemoglobin A1c (HbA1c) and in body weight.
Specifically, there was a reduction of 0.7 percentage points in HbA1c after 36 weeks and from the baseline; patients given a placebo had a 0.2 percentage point reduction. Those that received ISIS-PTP1BRx noticed a body weight reduction from baseline at 36 weeks as well. The full data on this Phase 2 randomized, double-blinded and placebo-controlled study that enrolled 92 type 2 diabetic patients will be published later this year.
Despite the range of therapies available, those with type 2 diabetes continue to have problems in controlling their blood glucose levels. The insulin sensitizers available have to be used cautiously since side effects might be experienced.
Sanjay Bhanot, Isis Pharmaceuticals’ representative, said in a press release: “We designed ISIS-PTP1BRx to act as an insulin sensitizer to enhance glycemic control by specifically targeting protein-tyrosine phosphatase 1B (PTP-1B). The results from this study and our earlier clinical experience with PTP-1B suggest that addressing this novel therapeutic target for type 2 diabetes with ISIS-PTP1BRx may have the potential to offer a safer more effective approach for patients with type 2 diabetes who are progressing in their disease.” Bhanot also said that there is a lot to be excited about because of the success with body weight and glucose control improvements in the trial, and explained that longer-term treatment with ISIS-PTP1BRx will bring more positive glucose control.
ISIS-PTP1BRx cannot only delay the necessity of insulin but also increase the effectiveness of the insulin therapy.
“We and our advisors believe that ISIS-PTP1BRx could be developed for patients with type 2 diabetes who are failing oral antidiabetic therapies or GLP-1 agonists, thereby delaying the need to initiate insulin therapy. These data also support the development of ISIS-PTP1BRx for patients who are insulin-resistant, remain uncontrolled even on high doses of insulin and in whom an insulin sensitizer could provide significant benefit,” explained Lynne Parshall, Isis Pharmaceuticals’ chief operating officer. She also clarified that these findings may also represent relevant advances to address obese diabetic patients.