First patient dosed in long term-safety extension study of Resolaris for adult patients with FSHD

Sep 10 2015

aTyr Pharma, Inc. (Nasdaq: LIFE), a biotherapeutics company engaged in the discovery and development of Physiocrine-based therapeutics to address severe rare diseases, today announced that the first patient has been dosed in a newly initiated long term-safety extension study of Resolaris™ for adult patients with facioscapulohumeral muscular dystrophy (FSHD), a rare and severe genetic myopathy for which there are currently no approved treatments.

The open label study is designed to assess the long-term safety, tolerability and biological activity of Resolaris™ and will include adult patients who are currently enrolled in an ongoing, double-blind, placebo-controlled, multiple ascending dose Phase 1b/2 trial of Resolaris™ in adult patients with FSHD. Data from the Phase 1b/2 study are expected in the fourth quarter of 2015 or first quarter of 2016. The extension study is expected to continue through mid-2016.

"Our Resolaris extension study takes the next step in developing a new class of Physiocrine-based medicines for patients who currently have few options. The trial will also expand our growing safety and tolerability database over a longer treatment period," said John Mendlein, Ph.D., CEO and executive chairman of aTyr Pharma. "When given in therapeutic doses, we believe Physiocrine-based therapies may productively modulate immune processes by rebalancing the immune systems in chronic rare muscle diseases to provide new options for these severely affected patients."

Resolaris™ is the first Physiocrine-based therapeutic under investigation for any disease and is based on a naturally occurring protein identified by aTyr Pharma. The Company is also planning trials in additional indications, including early onset FSHD and limb-girdle muscular dystrophy (LGMD) 2B, and both are expected to initiate later this year.

SOURCE aTyr Pharma, Inc.