Boehringer Ingelheim has launched a 12-week North American and European Phase IIa proof of clinical principle study with a compound in the treatment of nonalcoholic steatohepatitis (NASH), a liver disorder that is often prevalent among patients with Type 2 Diabetes.
Nonalcoholic fatty liver disease is the most common liver disorder in Western industrialized nations. The more serious form of the disease, NASH, is a major cause of liver fibrosis and cirrhosis and is an area of high unmet medical need with no treatments currently available, according to a statement by Boehringer Ingelheim.
Boehringer Ingelheim, which has its U.S. headquarters in Ridgefield, acquired BI 1467335 (formerly known as PXS-4728A), from the Australian company Pharmaxis in May 2015. In a press statement, the company explained that BI 1467335 is “an oral inhibitor of amine oxidase, copper containing 3 (AOC3)1, and works by blocking leucocyte adhesion and tissue infiltration in inflammatory processes underlying NASH.” The U.S. Food and Drug Administration gave Boehringer Ingelheim Fast Track Designation last year for the development of BI 1467335 in NASH.
The new study will seek to establish proof of clinical principle, determine suitable dosing and evaluate product safety, with test patients divided between one group receiving either one of four dosages of BI 1467335 or a placebo. A subsequent Phase IIb study will be conducted to confirm the results of the Phase IIa tests.