aTyr Pharma (LIFE) Granted FDA Fast Track Status for Resolaris
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aTyr Pharma, Inc. (Nasdaq: LIFE) announced that its product candidate Resolaris™ was granted Fast Track designation by the US Food and Drug Administration (FDA) for the treatment of facioscapulohumeral muscular dystrophy (FSHD), making it the first known therapeutic candidate for the treatment of FSHD to receive the designation. Resolaris, a designated Orphan Drug in FSHD, is currently being studied in a Phase 1b/2 clinical program.
"This Fast Track designation, which is granted to drug candidates addressing serious conditions and that demonstrate the potential to address unmet medical needs, represents another step forward for our rare muscle disease franchise," said John Mendlein, PhD, CEO of aTyr Pharma. "This designation highlights the significant need to develop and ultimately approve meaningful new therapeutics to treat patients with rare myopathies, such as FSHD."
Fast Track is a process designed by the FDA to facilitate the development and expedite the review of new drugs, biologics or treatments. Product candidates may be eligible for priority review at the time of a Biologic License Application (BLA) filing and may also be eligible to submit completed sections of the BLA on a rolling basis. Importantly, the therapy's sponsors are eligible for more frequent written communication and meetings with the FDA, the benefit of which may be to develop a pivotal study design which more closely meets the FDA's criteria, thereby creating a more collaborative and efficient pathway to approval.
Resolaris is currently being studied in a Phase 1b/2 clinical program for three types of rare myopathies with an immune component. The Company expects to report data from the following three clinical trials in December 2016:
- Phase 1b/2 study in patients with early-onset FSHD (003 Trial)
- Phase 1b/2 study in patients with FSHD and Limb Girdle Muscular Dystrophy 2B (LGMD2B) (004 Trial)
- Phase 1b/2 Extension study in patients with FSHD (005 Trial)
The primary objectives of these trials are to establish a safety and tolerability database and to explore and establish activity signals, such as various endpoints and biomarkers, which will best inform aTyr's clinical development path forward, including endpoints for a BLA.
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