Eight years after Japan’s Kyowa Hakko Kirin was handed an FDA rejection for its Parkinson’s drug istradefylline (KW-6002), researchers say they recorded a Phase III flop for the drug.
The drug, approved in Japan, is designed to reduce the amount of daily off-time patients experience with levodopa. But while Kyowa Hakko’s team tracked a trend in favor of the 20 mg and 40 mg doses, they did not hit statistical significance.
The drug fits into a well-studied arena of adenosine A2A receptor antagonists. Merck said back in 2013 that its late-stage program for preladenant showed it was no better than a placebo in treating Parkinson’s, causing the pharma giant to drop the therapy. But Acorda bought Biotie and its adenosine A2A receptor antagonist drug tozadenant (SYN115) in a $363 million deal at the beginning of 2016, after seeing positive mid-stage data.