aTyr Pharma Announces Positive Topline Results from Phase 2 Clinical Trial of ATYR1923 in COVID-19 Patients with Severe Respiratory Complications
Study met primary safety endpoint in moderate to severe hospitalized COVID-19 patients.
A single dose of 3.0 mg/kg of ATYR1923 resulted in a median time to recovery of 5.5 days.
83% of patients receiving 3.0 mg/kg dose of ATYR1923 achieved recovery in less than a week.
Management to host conference call and webcast today,
“We are pleased with the results of this study which continue to demonstrate ATYR1923’s favorable safety profile in inflammatory lung conditions,” said
The study demonstrated a preliminary signal of activity through clinical improvement in the high dose cohort with the assessment of time to recovery, defined as either achieving a WHO ordinal scale score of ≤3 or hospital discharge with no requirement of supplemental oxygen. Patients who received the 3.0 mg/kg dose of ATYR1923 experienced a median time to recovery of 5.5 days compared to 6 days in the placebo group. In addition, 83% of patients receiving the high dose of ATYR1923 achieved recovery by day 6, compared to 56% in the placebo arm. Patients in the 1.0 mg/kg treatment arm experienced a median time to recovery of 7 days. All patients in the study received standard of care treatment at the time of enrollment, which included remdesivir and/or dexamethasone.
Adverse events were mostly mild or moderate in severity and generally assessed as unrelated to the study drug. This is in line with previous safety assessments of ATYR1923, including an interim safety analysis from an ongoing Phase 1b/2a trial in patients with pulmonary sarcoidosis, a chronic form of interstitial lung disease. There were two deaths observed in the study, both in the 1.0 mg/kg treatment arm, which were deemed not related to ATYR1923 by an independent data safety monitoring board.
The Phase 2 clinical trial was a randomized, double blind, placebo-controlled study of ATYR1923 in 32 hospitalized COVID-19 patients with severe respiratory complications, who did not require mechanical ventilation, at hospitals in the
“Against the backdrop of the rapidly evolving standard of care for COVID-19 patients, we have reaffirmed the positive safety profile of ATYR1923 observed in our ongoing trial in patients with pulmonary sarcoidosis, a chronic form of inflammatory lung disease. We have also elucidated a signal of drug activity from a single 3.0 mg/kg dose of ATYR9123 in this small trial. I would like to thank the clinical sites, investigators and patients that contributed to these important findings,” said
aTyr is developing ATYR1923 as a potential therapeutic for patients with inflammatory lung diseases. ATYR1923, a fusion protein comprised of the immuno-modulatory domain of histidyl tRNA synthetase fused to the FC region of a human antibody, is a selective modulator of neuropilin-2 that downregulates the innate and adaptive immune response in inflammatory disease states. aTyr recently completed enrollment in a proof-of-concept Phase 1b/2a trial evaluating ATYR1923 in patients with pulmonary sarcoidosis. This Phase 1b/2a study is a multi-ascending dose, placebo-controlled, first-in-patient study of ATYR1923 that has been designed to evaluate the safety, tolerability, steroid sparing effect, immunogenicity and pharmacokinetic profile of multiple doses of ATYR1923. In response to the COVID-19 pandemic, aTyr completed a Phase 2 clinical trial with ATYR1923 in COVID-19 patients with severe respiratory complications. This Phase 2 study was a randomized, double blind, placebo-controlled study that was designed to evaluate the safety and preliminary efficacy of a single dose of ATYR1923.
aTyr is a biotherapeutics company engaged in the discovery and development of innovative medicines based on novel biological pathways. aTyr’s research and development efforts are concentrated on a newly discovered area of biology, the extracellular functionality and signaling pathways 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 and their extracellular targets. aTyr’s primary focus is ATYR1923, a clinical-stage product candidate which binds to the neuropilin-2 receptor and is designed to down-regulate immune engagement in inflammatory lung diseases. For more information, please visit http://www.atyrpharma.com.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. 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 include statements regarding potential therapeutic benefits and applications of ATYR1923; timelines and plans with respect to certain development activities (such as the timing of data from clinical trials); and certain development goals. 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. All forward-looking statements are based on estimates and assumptions by our management that, although we believe to be reasonable, are inherently uncertain. 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, uncertainty regarding the COVID-19 pandemic, risks associated with the discovery, development and regulation of our product candidates, the risk that we or our partners 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), the possibility that existing collaborations could be terminated early, 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
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Source: aTyr Pharma, Inc.