ATYR1923 (iMod.Fc)

About ATYR1923

iMOD.fc

Our lead product candidate, ATYR1923, is a selective modulator of Neuropilin-2 that downregulates the innate and adaptive immune response in inflammatory disease states. We are developing ATYR1923 as a potential therapeutic for patients with interstitial lung diseases (ILD).

ATYR1923 is a fusion protein comprised of the immuno-modulatory domain (iMod) of histidyl tRNA synthetase (HARS) fused to the FC region of a human antibody. iMod is a naturally occurring splice variant of HARS that is relatively overexpressed in lung tissue.

Preclinical Development

ATYR1923 has demonstrated anti-inflammatory and anti-fibrotic effects in rodent models (ATS 2017, ATS 2018) of interstitial lung disease, including bleomycin induced lung fibrosis models and a scleradermatous chronic graft vs host disease model (Scleroderma Foundation Patient Conference 2018).

Clinical Development

We completed a Phase 1 trial with ATYR1923 in healthy volunteers in 2018. This randomized, double-blind, placebo controlled, single ascending dose study investigated the safety, tolerability immunogenicity and pharmacokinetics (PK) of intravenous ATYR1923 in 36 healthy volunteers. The results indicate that the drug was generally well-tolerated at all dose levels tested, with no significant adverse events and the observed PK profile supports the potential for a once-monthly intravenous dosing regimen.

We initiated a proof-of-concept Phase 1b/2a trial evaluating ATYR1923 in patients with pulmonary sarcoidosis in the fourth quarter of 2018. This Phase 1b/2a study is a multiple-ascending dose, placebo-controlled, first-in-patient study of ATYR1923 that has been designed to evaluate the safety, tolerability, steroid sparing effect, immunogenicity and PK profile of multiple doses of ATYR1923, as well as to evaluate well-established clinical endpoints and certain biomarkers to assess preliminary efficacy.

Please click here to learn more about our ongoing clinical program.

For the Phase 1b/2a trial, we are collaborating with the Foundation for Sarcoidosis Research (FSR), the nation’s leading nonprofit organization dedicated to finding a cure for sarcoidosis and improving care for sarcoidosis patients. Under the terms of the collaboration, FSR will assist with clinical trial site initiation and patient enrollment. We anticipate that up to twelve sites in the United States will participate in the study. FSR’s Clinical Studies Network (FSR-CSN), which is led by a steering committee consisting of principal investigators from leading clinical centers, has voted to support this proof-of-concept study.

Please click here to learn more about the Foundation for Sarcoidosis Research.

About Interstitial Lung Disease

Interstitial Lung Diseases (ILD) are a group of immune-mediated disorders which cause progressive fibrosis of lung tissue. There are over 100 different types of ILD, of which the four major forms are: pulmonary sarcoidosis, connective tissue disease-associated ILD (e.g., rheumatoid arthritis ILD and systemic sclerosis-associated ILD), chronic hypersensitivity pneumonitis (CHP) and idiopathic pulmonary fibrosis. Patients with ILD may experience severe morbidity and mortality with limited therapeutic options available. We believe ATYR1923 has potential to be a disease modifying therapy in several severe, progressive forms of ILD that share an immune-pathophysiology.

About Pulmonary Sarcoidosis

Sarcoidosis is an inflammatory disease characterized by the formation of granulomas, clumps of inflammatory cells, in one or more organs in the body. Sarcoidosis affects people of all ages, but typically presents before the age of 50 years, with the incidence peaking at 20 to 39 years. The disorder usually begins in the lungs, skin or lymph nodes, but can affect almost any organ. Sarcoidosis in the lungs is called pulmonary sarcoidosis and occurs in 90% or more of patients. Estimates of prevalence vary; however, aTyr believes that approximately 200,000 Americans live with pulmonary sarcoidosis. The prognosis for patients with pulmonary sarcoidosis ranges from benign and self-limiting to chronic, debilitating disease with mortality.

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