Wired News – Voyager Therapeutics Declared Longer-term Data from Phase-1b Trial Of VY-AADC for Advanced Parkinson’s Disease
Stock Monitor: Editas Medicine Post Earnings Reporting
LONDON, UK / ACCESSWIRE / March 13, 2018 / Active-Investors.com has just released a free research report on Voyager Therapeutics, Inc. (NASDAQ: VYGR). If you want access to this report all you need to do is sign up now by clicking the following link www.active-investors.com/registration-sg/?symbol=VYGR as the Company's latest news hit the wire. On March 09, 2018, the Company announced longer-term data from its ongoing dose-ranging Phase-1b trial of VY-AADC in advanced Parkinson's disease. The results continue to demonstrate durable, dose-dependent, and time-dependent improvements across multiple measures of patients' motor function after a one-time administration of the gene therapy. Register today and get access to over 1,000 Free Research Reports by joining our site below:
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Objectives of Ongoing Phase-1b Trial of VY-AADC
The Phase-1b, open-label trial includes 15 patients with advanced Parkinson's disease and disabling motor fluctuations, treated in Cohorts 1, 2, and 3 with a single administration of VY-AADC. The primary objectives of the trial are to assess the safety and tolerability of VY-AADC and to test the distribution of ascending doses of VY-AADC administered under MRI guidance to the putamen, a region of the brain associated with impaired motor function in Parkinson's disease. Secondary objectives include assessment of AADC expression and activity in the putamen measured by positron emission tomography (PET), which reflects the capacity to convert levodopa to dopamine. Other secondary measures include assessments of motor function and activities of daily living, as measured by the Unified Parkinson's Disease Rating Scale (UPDRS-III and UPDRS-II, respectively), quality of life, and a patient-completed Hauser diary.
Updated Results of Phase-1b Trial
The results from the ongoing Phase-1b trial of VY-AADC include data from patients in Cohort 1 at three years, Cohort 2 at 18 months and Cohort 3 at one year. The updated results suggest a durable 2.1-hour improvement in patient-reported diary on-time without troublesome dyskinesia from baseline to three years for patients in Cohort 1, a durable and clinically meaningful 3.5-hour improvement from baseline to 18 months in Cohort 2, and an improvement from baseline to six months of 1.5 hours that plateaued from six to 12 months in Cohort 3.
VY-AADC also generated durable improvements in other measures of motor function including decreases in both diary off-time and diary on-time with troublesome dyskinesia and increases in both diary on-time without dyskinesia and diary on-time with non-troublesome dyskinesia. In Cohort 2 at 18 months, patients had a mean increase of 5.1 hours a day of on-time without any dyskinesia and experienced 65% less off-time. Additionally, VY-AADC improved patients' quality of life as measured by the UPDRS-II activities of daily living section. Infusions of VY-AADC have been well-tolerated with no vector-related serious adverse events (SAEs).
Voyager to Consider Cohort 2 Dose as Optimal Dose in the Pivotal Program
Voyager systematically increased the dose of VY-AADC In Phase-1b trial, to select an optimal dose prior to initiating its pivotal program. Given the improvements in motor function and wider spectrum to titrate oral levodopa with Cohort 2 dose, the Company will consider this as its likely dose in the pivotal program while still planning to review the six-month results from the Phase 1 posterior trajectory trial next quarter. Voyager plans to meet with the US Food and Drug Administration (FDA) during a Type C meeting to discuss the current Phase-1b data for the pivotal program. The Company continues to expect to dose the first patient in the pivotal Phase-2-3 program in mid-2018.
FDA Approved IND Application for VY-AADC for Advanced Parkinson's Disease
On January 23, 2018, the FDA accepted the Investigational New Drug (IND) application for VY-AADC, allowing Voyager to initiate clinical trial sites, screen and begin dosing patients for its pivotal Phase-2-3 program for advanced Parkinson's disease. As part of this IND, the chemistry, manufacturing, and controls section included data demonstrating comparability between VY-AADC produced under good manufacturing practice (GMP) using Voyager's baculovirus/Sf9 manufacturing process.
What is Parkinson's Disease?
Parkinson's disease is a neurodegenerative disorder, which leads to progressive deterioration of motor function due to loss of dopamine-producing brain cells. Most individuals with Parkinson's disease are diagnosed when they are 60 years old or older, but early-onset Parkinson's disease also occurs. Several staging systems for this disease exist depending upon the organization that treats and researches the disease. Stage 5 is the most advanced stage of Parkinson's disease. Symptoms during the advanced stages of the disease include falling, gait freezing, and difficulty with speech and swallowing, with patients often requiring the daily assistance of a caregiver.
About VY-AADC
VY-AADC, which is comprised of the adeno-associated virus-2 capsid and a cytomegalovirus promoter to drive aromatic L-amino acid decarboxylase (AADC) transgene expression, is designed to deliver the AADC gene directly into neurons of the putamen where dopamine receptors are located, bypassing the substantia nigra neurons and enabling the neurons of the putamen to express the AADC enzyme to convert levodopa into dopamine. The approach with VY-AADC, therefore, has the potential to durably enhance the conversion of levodopa to dopamine and provide clinically meaningful improvements by restoring motor function in patients and improving symptoms following a single administration.
Stock Performance Snapshot
March 12, 2018 - At Monday's closing bell, Voyager Therapeutics' stock dropped 9.71%, ending the trading session at $24.28.
Volume traded for the day: 1.36 million shares, which was above the 3-month average volume of 413.94 thousand shares.
Stock performance in the last month – up 34.81%; previous three-month period – up 76.71%; past twelve-month period – up 98.53%; and year-to-date - up 46.27%
After yesterday's close, Voyager Therapeutics' market cap was at $655.07 million.
The stock is part of the Healthcare sector, categorized under the Biotechnology industry.
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