Bayer’s billion-dollar Parkinson’s bet pays off with FDA fast track designation

Weeks after kicking off Phase I trial, the German pharma’s Parkinson’s candidate lands fast-track designation.

Since BlueRock Therapeutics' founding back in 2016, Bayer had owned 40% of the entity, with its partner Versant Ventures owning the rest. Back in 2019, the German pharma paid $240 million to acquire the remaining stake in BlueRock. The deal, which also included payments of up to $360 million in development milestones had a total value of up to a billion. Through it, Bayer also took control of a late-preclinical candidate called DA01 - a pluripotent stem cell-derived dopaminergic neuron therapy aimed at treating Parkinson’s disease. Parkinson’s is the most common neurodegenerative movement disorder and impacts about 10 million people worldwide. While BlueRock has been allowed to continue operating independently since then, the transaction afforded Bayer the opportunity to lead the emerging cell therapy sector.

In June this year, a Phase I trial for DA01 began, looking to enrol 10 participants in the U.S. and Canada. The trial was looking to assess the safety and tolerability of DA01 cell transplantation at one-year post-transplant. Fast forward several weeks later, BlueRock announced on 19 July that “the U.S. Food and Drug Administration (FDA) had granted Fast Track designation for DA01 for advanced Parkinson’s disease (PD)”. “The FDA’s Fast Track designation is intended to facilitate the development and review of drug candidates that treat serious conditions and address an unmet medical need. A drug candidate that receives Fast Track designation may be eligible for more frequent interaction with the FDA to discuss the candidate’s drug development plan as well as eligibility for accelerated approval and priority review” read the statement.