Pharmaceutical Business review

Islet Sciences gets notice of allowance from USPTO for new IL-12 inhibitors

The new patent will extend coverage to include a significantly broader gamut of chemical compounds, which the company might develop as immune-modulating drugs targeting an inflammatory pathway involved in a number important diseases, including diabetes and nonalcoholic steatohepatitis (NASH).

The company said that lisofylline (LSF) and its analogs have been shown to inhibit activation of pro-inflammatory immune signaling molecules IL-12 and STAT4, but clinical utility of these compounds has been limited by poor drug qualities.

Currently, the company is working to identify and develop first-in-class LSF analogs with superior chemical properties suitable for commercial drug development.

Initial screens uncovered first-generation IL-12 antagonists which were able to protect insulin-producing beta-cells and preserve islet function in vitro, as well as delay onset of type I diabetes in a mouse model.

Additional studies have shown that these immune modulators may directly reduce liver fibrosis in a rat model of NASH.

The parent molecule, LSF, has also been evaluated in three human clinical trials where it was well tolerated with no serious adverse events.

Islet Sciences chief operating officer William Wilkison said the company’s strategy is to develop a franchise of novel treatments for metabolic disease.

"This patent allowance further strengthens our dominant intellectual property position by broadening the scope of compounds we can develop as IL-12 antagonists, and in effect, potentially broadening the types of diseases we may be able to address," Wilkison said.

"In addition to diabetes and NASH, other studies suggest IL-12 inhibitors may be effective for atherosclerosis, diabetic nephropathy, and other diseases.

"We continue to create and screen additional compounds and expect to continue development of our current lead molecule ISLT-2669, as well as other lead candidates, once they are identified and sufficiently validated."