Kyowa Kirin axes Parkinson's med, saying development and regulatory hurdles are too daunting

Japan-based Kyowa Kirin says its Parkinson’s disease med may work, but it’s calling it quits regardless because the potential development and regulatory hurdles are too formidable. 

The company cited the "global regulatory landscape, development hurdles, and timelines for potential market entry" as reasons further investment into KW-6356 was untenable. The decision, announced Friday, comes even after phase 2 data for the adenosine receptor antagonist showed it had promise either as a monotherapy or in a combo therapy to treat Parkinson's disease. 

The timing of the decision is interesting given the company is now years removed from former partner Lundbeck backing out of a global licensing agreement for the drug. In August 2018, Kyowa Kirin, armed with positive proof-of-concept data, said it would continue to pursue development on its own.

Two months later, the company reported positive data when KW-6356 was given to Parkinson’s patients who were already treated with levodopa-containing preparations. Patients treated with the combo experienced statistically significant improvement in motor function compared to placebo. 

Since then, the costs and potential regulatory hurdles evidently became insurmountable. The company had not posted an update on the development progress of the drug following the positive phase 2 combo data.

The med was slated to be a follow-up to Nourianz, the company’s first adenosine-based treatment for Parkinson’s that was originally rejected by the FDA in 2008. But the company reapplied for approval in 2019, and the drug was subsequently approved in August of that year.