A Randomized, Placebo Surgery Controlled, Double-blinded, Multi-center, Phase 2 Clinical Trial, Evaluating the Efficacy and Safety of VY-AADC02 in Advanced Parkinson's Disease With Motor Fluctuations
Phase of Trial: Phase II
Latest Information Update: 03 Feb 2019
At a glance
- Drugs VY AADC (Primary)
- Indications Parkinson's disease
- Focus Adverse reactions; Pharmacokinetics; Registrational; Therapeutic Use
- Acronyms RESTORE-1
- Sponsors Voyager Therapeutics
- 29 Jan 2019 According to a Neurocrine Biosciences media release, the company and Voyager Therapeutics entered into a strategic collaboration under which, after the data readout from this trial, Voyager will either co-commercialise VY-AADC with Neurocrine Biosciences in the US under a 50/50 cost and profit-sharing arrangement and receive milestones and royalties based on ex-US sales, or grant full global commercial rights in exchange for milestone payments and royalties based on global sales.
- 07 Jan 2019 According to a Voyager Therapeutics media release, if positive, results from RESTORE-1 and RESTORE-2 could potentially form the basis for submission of a biologics license application (BLA) to the FDA for VY-AADC for the treatment of Parkinsons disease.
- 07 Jan 2019 According to a Voyager Therapeutics media release, based on the meeting discussion and subsequent written feedback from the FDA, Voyager plans to submit a revised trial protocol that will include an increase in the target number of patients in the RESTORE-1 Phase 2 trial, resulting in 75 to 100 total patients in the trial, and to conduct a staggered-parallel Phase 3 trial (RESTORE-2) of similar size and design to RESTORE-1.