SAN DIEGO, Sept. 27, 2018 (GLOBE NEWSWIRE) -- aTyr Pharma, Inc. (Nasdaq: LIFE), a biotherapeutics company engaged in the discovery and development of innovative medicines based on novel immunological pathways, today announced that it has selected pulmonary sarcoidosis as the disease indication for its upcoming ATYR1923 clinical study. In the fourth quarter of 2018, aTyr plans to initiate a Phase 1b/2a multiple-ascending dose, placebo-controlled, first-in-patient study with ATYR1923 for the treatment of patients with pulmonary sarcoidosis. The study has been designed to evaluate safety, tolerability and immunogenicity of multiple doses of ATYR1923. In addition, aTyr intends to evaluate established clinical endpoints and potential biomarkers to assess preliminary activity of ATYR1923.
From San Antonio, the site of the CHEST Annual Meeting 2018, aTyr will host an educational webinar on Monday, October 8, 2018 at 8:00 a.m. Eastern Time featuring Daniel Culver, D.O., Director of the Interstitial Lung Disease Program at the Cleveland Clinic. Dr. Culver is also the President-elect of the World Association of Sarcoidosis and Other Granulomatous Disorders and the Chair of the Scientific Advisory Board for the Foundation for Sarcoidosis Research. During the educational webinar, Dr. Culver will provide disease education on pulmonary sarcoidosis and its impact on patients. Sanjay Shukla, M.D., M.S., president and chief executive officer, will also provide an overview of the proposed ATYR1923 Phase 1b/2a clinical study design. Following the presentation, Drs. Culver and Shukla will be available to answer questions.
"Last quarter, we announced top-line results from our ATYR1923 Phase 1 study in healthy human volunteers. As previously indicated, we have used this data, along with recent translational research results and discussions with key opinion leaders, to guide our development plans for ATYR1923,” said Dr. Shukla. "We are pleased to announce pulmonary sarcoidosis as the indication for our next study. Dr. Culver is a leading expert in the field and we appreciate his participation in our upcoming educational webinar to provide an overview of pulmonary sarcoidosis and the unmet medical need."
Conference Call and Webcast Details
Date: Monday, October 8, 2018
Time: 8:00 a.m. Eastern Time
To access the call, please dial 844-358-9116 (domestic) or 209-905-5951 (international) and ask to join the aTyr Pharma call.
The live webcast and slide presentation will be available on the Investors page of the Company's website at www.atyrpharma.com. A replay of the webcast will be archived on the Company’s website following the call.
About ATYR1923
aTyr scientists successfully engineered ATYR1923, a fusion protein comprised of the immuno-modulatory domain of histidyl tRNA synthetase (HARS) fused to the FC region of a human antibody. aTyr is developing ATYR1923 as a potential therapeutic for patients with interstitial lung diseases. aTyr announced data from a first-in-human Phase 1 clinical trial of ATYR1923 in June 2018. This randomized, double-blind, placebo-controlled 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 dosing regimen.
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 90% or more of patients with sarcoidosis have lung involvement. Pulmonary sarcoidosis is a major form of interstitial lung disease (ILD) a group of immune-mediated disorders which cause progressive fibrosis of lung tissue. Estimates of prevalence vary; however, aTyr believes that approximately 150,000 to 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.
About aTyr
aTyr is a biotherapeutics company engaged in the discovery and development of innovative medicines based on novel immunological pathways. aTyr’s research and development efforts are concentrated on a newly discovered area of biology, the extracellular functionality of tRNA synthetases. aTyr has built a global intellectual property estate directed to a potential pipeline of protein compositions derived from 20 tRNA synthetase genes. aTyr is focused on the therapeutic translation of the Resokine pathway, comprised of extracellular proteins derived from the histidyl tRNA synthetase gene family. ATYR1923 is a clinical-stage product candidate which binds to the neuropilin-2 receptor and is designed to down-regulate immune engagement in interstitial lung diseases and other immune-mediated diseases. For more information, please visit http://www.atyrpharma.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Litigation Reform Act. Forward-looking statements are usually identified by the use of words such as “anticipates,” “believes,” “estimates,” “expects,” “intends,” “may,” “plans,” “projects,” “seeks,” “should,” “will,” and variations of such words or similar expressions. We intend these forward-looking statements to be covered by such safe harbor provisions for forward-looking statements and are making this statement for purposes of complying with those safe harbor provisions. These forward-looking statements, including statements regarding the potential therapeutic benefits and applications of our product candidates; our ability to successfully advance our product candidates, undertake certain development activities (such as the initiation of clinical trials, clinical trial enrollment, the conduct of clinical trials and the announcement of top-line results) and accomplish certain development goals, and the timing of such events; and the scope and strength of our intellectual property portfolio. These forward-looking statements also reflect our current views about our plans, intentions, expectations, strategies and prospects, which are based on the information currently available to us and on assumptions we have made. Although we believe that our plans, intentions, expectations, strategies and prospects, as reflected in or suggested by these forward-looking statements, are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in these forward-looking statements and will be affected by a variety of risks and factors that are beyond our control including, without limitation, risks associated with the discovery, development and regulation of our product candidates, the risk that we may cease or delay preclinical or clinical development activities for any of our existing or future product candidates for a variety of reasons (including difficulties or delays in patient enrollment in planned clinical trials), and the risk that we may not be able to raise the additional funding required for our business and product development plans, as well as those risks set forth in our most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and in our other SEC filings. Except as required by law, we assume no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.
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