Kyowa Hakko Kirin hit with a new PhIII setback on an old Parkinson’s drug

Yoichi Sato, Kyowa Hakko Kirin

Yoichi Sato, Kyowa Hakko Kirin

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.

Despite the miss for a rejected therapy, the Kyowa Hakko still believes it has a chance to win over regulators.

“The results of this global Phase 3 trial of istradefylline are not what we expected,” said Yoichi Sato, Managing Executive Officer, Vice President, Head of Research and Development Division of Kyowa Hakko Kirin. “We need to fully understand the study results and will present further findings including those from the secondary outcome measures at upcoming scientific congresses and/or in scientific journals. In addition, we will pursue a chance to work with FDA and discuss potential for successful submission.”

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