BRIEF—IND clearance for BlueRock's DA01 in Parkinson's disease

BlueRock Therapeutics (which Germany’s Bayer acquired for around $1 billion in 2019), in collaboration with Memorial Sloan Kettering Cancer Center (MSK), today announced that the US Food and Drug Administration has cleared their Investigational New Drug (IND) application to proceed with a Phase I study in patients with advanced Parkinson’s disease (PD).

This is the first trial in the USA to study pluripotent stem cell-derived dopaminergic neurons in patients with Parkinson’s disease.

Under the IND, BlueRock and MSK will execute a Phase I clinical trial to evaluate the safety, tolerability and preliminary efficacy of DA01 in patients with PD.

“This is a big step for the stem cell field – to finally test a truly “off-the-shelf” dopamine neuron product in human PD patients,” said Dr Lorenz Studer, scientific co-founder of BlueRock and director, Center for Stem Cell Biology at MSK, adding: “We are also grateful for the visionary support by NYSTEM, the NY state-sponsored stem cell program that supported the earlier stages of this project.”