The FDA Has Granted Prevail’s Parkinson’s Treatment Fast Track Designation

Posted on

Prevail Therapeutics shares were on the rise on Monday after Wall Street learned that the Food & Drug Administration had granted fast track designation for PR001 for the treatment of Parkinson’s disease patients with a GBA1 mutation.

Parkinson’s disease is a chronic, progressive neurodegenerative disorder that affects up to one million people in the United States and more than seven million people worldwide. PD-GBA affects 7% to 10% of the total Parkinson’s disease population worldwide and an estimated 90,000 individuals in the United States alone.

“We are pleased that the FDA has granted Fast Track Designation for PR001, which underscores the unmet need of patients with Parkinson’s disease with a GBA1 mutation, a chronic and progressive neurodegenerative disorder that comprises 7% to 10% of the total Parkinson’s disease population worldwide,” commented CEO Asa Abeliovich.

Abeliovich added, “With no treatments available that modify the progressive course or the underlying disease process of Parkinson’s disease, a potential disease-modifying therapy like PR001 could significantly transform the lives of patients with this disease.”

The company’s press release stated, “Following the FDA’s acceptance of Prevail’s Investigational New Drug (IND) application in June, the Company is on track to begin dosing patients in a Phase 1/2 clinical trial in the second half of 2019. The trial will investigate the safety and tolerability of PR001, and will also measure key biomarkers and exploratory efficacy endpoints, in patients with PD-GBA.”

Disclaimer: We have no position in Prevail Therapeutics Inc. (NASDAQ: PRVL) and have not been compensated for this article.