BlueRock Therapeutics Announces FDA Fast Track Designation for DA01 Cell Therapy in Advanced Parkinson’s Disease

CAMBRIDGE, Mass., July 20, 2021 /PR Newswire/ --July 19, 2021,BlueRock Therapeutics, a wholly owned clinical-stage biopharmaceutical subsidiary of Bayer AG, announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to its therapy DA01 for the treatment of advanced Parkinson’s disease (PD). DA01 is a therapy that utilizes pluripotent stem cells to generate dopaminergic neurons and is currently being evaluated in a Phase I clinical trial.

The FDA Fast Track designation is intended to facilitate the development and accelerate the approval process of novel therapies for serious conditions that address unmet medical needs. Drug candidates granted Fast Track designation will be eligible for more frequent interactions with the FDA to discuss development plans, as well as to qualify for Accelerated Approval and Priority Review.

Dr. Joachim Fruebis, Chief Development Officer at BlueRock Therapeutics, stated: "Receiving FDA Fast Track designation is an important step that will help us further accelerate the clinical development of DA01, our cell therapy for Parkinson’s disease. This is also a key step in BlueRock’s mission: to create truly transformative cell medicines, reverse devastating diseases, and fulfill our vision of improving human health."

About This Clinical Trial

The trial will enroll 10 patients in the United States and Canada. The primary objective of this Phase I clinical study is to evaluate the safety and tolerability of DA01 cell transplantation at one year post-transplantation. The secondary objectives are to assess evidence of transplanted cell survival and motor effects at one and two years post-transplantation, evaluate continued safety and tolerability at two years, and assess the feasibility of the transplantation. For more information regarding this trial, please visit clinicaltrials.gov (NCT#04802733).

About Parkinson's Disease

Parkinson's disease is a progressive neurodegenerative disorder caused by damage to nerve cells in the brain, leading to reduced dopamine levels. The worsening of motor and non-motor symptoms is driven by the loss of dopamine-producing neurons. At the time of diagnosis, patients are estimated to have already lost 60% to 80% of their dopaminergic neurons. Parkinson's disease typically begins with a tremor in one hand. Other symptoms include rigidity, muscle spasms, and movement disorders. It is the second most common neurodegenerative disease, affecting over 7.5 million people globally, including 1.3 million in North America.