– Second Physiocrine-based therapeutic candidate enters the clinic –

– Top-line data expected in 2Q 2018 –

– iMod.Fc (ATYR1923) to target interstitial lung diseases with an immune component –

SAN DIEGO, CA, USA I November 27, 2017 I aTyr Pharma, Inc. (Nasdaq:LIFE), a biotherapeutics company engaged in the discovery and development of immuno-modulatory protein therapeutics to treat patients suffering from rare, severe, immune-mediated diseases, as well as various cancers, today announced that it has dosed the first subjects in a Phase 1 trial of iMod.Fc (ATYR1923), aTyr’s first engineered Physiocrine and second therapeutic candidate, in development for the treatment of interstitial lung diseases (ILDs). 

“The initiation of this study of iMod.Fc represents a significant milestone in the advancement of our programs and marks the second therapeutic candidate leveraging our understanding of the Resokine pathway to enter the clinic,” said Sanjay Shukla, M.D., M.S., President and CEO of aTyr Pharma. “We look forward to announcing top-line results from this study in the second quarter of 2018, which we will use to guide our future development plans for iMod.Fc as we explore the potential of the Resokine pathway in restoring tissue homeostasis in patients with interstitial lung disease.”

This first-in-human, randomized, double-blind, placebo-controlled study is designed to investigate the safety, tolerability, immunogenicity, pharmacokinetics and pharmacodynamics of intravenous iMod.Fc (ATYR1923) in healthy volunteers. Subjects will be randomized to one of six cohorts and receive a single infusion of iMod.Fc (ATYR1923) or placebo. Doses of iMod.Fc (ATYR1923) will range from 0.03 mg/kg up to 5.0 mg/kg. Primary outcome measures will assess safety and tolerability in subjects for up to one month following dosing.

For additional information on this study, please visit www.anzctr.org.au.

About iMod.Fc (ATYR1923)

aTyr Pharma engineered the first Physiocrine fusion protein, iMod.Fc (ATYR1923), to enhance the pharmacokinetic properties of the Physiocrine protein in vivo. The company is developing iMod.Fc (ATYR1923) as a potential therapeutic for patients with rare pulmonary diseases with an immune or fibrotic component, including interstitial lung diseases. This fusion protein, which utilizes the Fc region of an antibody, also potentially represents a novel Fc-Physiocrine platform for future Physiocrine-based therapies.

About Interstitial Lung Diseases

Interstitial lung disease refers to a complex group of pulmonary disorders primarily affecting the pulmonary interstitium. Most of these disorders cause progressive scarring of lung tissue, eventually affecting the ability to breathe and the transfer of oxygen into the bloodstream. ILDs can develop in response to environmental injury, auto-immune mediated inflammation, or from unknown causes. The spectrum of ILDs includes idiopathic pulmonary fibrosis, sarcoidosis, hypersensitivity pneumonitis, and connective tissue disease-associated ILDs among others.

About Physiocrines

Physiocrines comprise naturally occurring proteins that aTyr believes promote homeostasis, a fundamental process of restoring stressed or diseased tissue to a healthier state. Physiocrines are extracellular signaling regions of tRNA synthetases, an ancient family of enzymes that catalyze a key step in protein synthesis. Physiocrines offer the opportunity for modulating biological pathways through newly discovered, naturally occurring mechanisms, many of which may provide advantages over other types of immune-modulatory therapeutics, including the potential for improved patient outcomes and reduced side effect profiles.

About aTyr Pharma

aTyr Pharma is engaged in the discovery and development of innovative medicines for patients using its knowledge of Physiocrine biology, a newly discovered set of immunological and physiological pathways. To date, aTyr has generated three innovative and unique development programs based on its knowledge of the Resokine pathway to treat patients suffering from rare, severe, immune-mediated diseases, as well as various cancers. aTyr’s two lead programs, Resolaris and iMod.Fc, are agonists of the Resokine pathway designed to temper immune engagement in diseases characterized by excessive immune cell involvement. aTyr’s third program, ORCA, represents a preclinical research program that targets a novel, proprietary immuno-oncology pathway using antibodies to enhance the immune response in tumor settings. aTyr has built an intellectual property estate, to protect its pipeline, comprising over 220 issued patents or allowed patent applications that are owned or exclusively licensed, including over 300 potential Physiocrine-based protein compositions. For more information, please visit http://www.atyrpharma.com.

SOURCE: aTyr Pharma