Post-hoc analysis from Phase 1b/2a study in pulmonary sarcoidosis presented at the European Respiratory Society (ERS) International Congress 2023.

在欧洲呼吸学会（ERS）2023年国际大会上提出的肺结节病1b/2a期研究的事后分析。

7.7% of patients in the 3.0 and 5.0 mg/kg efzofitimod group relapsed following steroid taper, compared to 54.4% in the placebo and efzofitimod 1.0 mg/kg group (p=0.017).

3.0和5.0 mg/kg efzofitimod组7.7%的患者在类固醇减量后复发，而安慰剂组和efzofitimod 1.0 mg/kg组为54.4%（p=0.017）。

Rate of change for forced vital capacity (FVC) was significantly improved for the 3.0 and 5.0 mg/kg efzofitimod group compared to placebo and the efzofitimod 1.0 mg/kg group (p=0.035).

与安慰剂组和efzofitimod 1.0 mg/kg组相比，3.0和5.0 mg/kg efzofitimod组的强制肺活量（FVC）变化率显着改善（p=0.035）。

SAN DIEGO, Sept. 11, 2023 (GLOBE NEWSWIRE) -- aTyr Pharma Inc. (Nasdaq: LIFE) (aTyr or the Company), a clinical stage biotechnology company engaged in the discovery and development of first-in-class medicines from its proprietary tRNA synthetase platform, today announced the results of a post-hoc analysis of data from its Phase 1b/2a study of efzofitimod in patients with pulmonary sarcoidosis.

圣地亚哥，2023年9月11日（GLOBE NEWSWIRE）-aTyr Pharma Inc.（纳斯达克股票代码：LIFE）（aTyr或该公司），一家临床阶段生物技术公司，从事发现和开发一流药物来自其专有的tRNA合成酶平台，今天宣布了对肺结节病患者efzofitimod 1b/2a期研究数据的事后分析结果。

The analysis was presented in a poster at the European Respiratory Society (ERS) International Congress 2023, which is taking place September 9 – 13, 2023, in Milan, Italy. The poster is available on the Company’s website..

该分析在2023年9月9日至13日在意大利米兰举行的欧洲呼吸学会（ERS）国际大会2023上的海报中展示。海报可在公司的网站上找到。。

“This new data from a post-hoc analysis, which pools efzofitimod 3.0 and 5.0 mg/kg and placebo and efzofitimod 1.0 mg/kg doses from the Phase 1b/2a study of efzofitimod in patients with pulmonary sarcoidosis, is yet another indicator of the robust efficacy demonstrated in this study,” said Sanjay S.

“这项来自事后分析的新数据，汇集了来自肺结节病患者的efzofitimod 1b/2a期研究的efzofitimod 3.0和5.0 mg/kg以及安慰剂和efzofitimod 1.0 mg/kg剂量，这是另一项强有力的指标在这项研究中证明的疗效，“Sanjay S。

Shukla, M.D., M.S., President and CEO of aTyr. “The statistically significant difference in the relapse rate following steroid taper seen in the two highest efzofitimod dose groups, combined with significantly improved FVC and quality of life measures, suggests that efzofitimod has the potential to be the first steroid-sparing and disease-modifying treatment for sarcoidosis.”.

Shukla，M.D.，M.S.，aTyr的总裁兼首席执行官。“在两个最高的efzofitimod剂量组中观察到的类固醇锥度后复发率的统计学显着差异，加上显着改善的FVC和生活质量测量，表明efzofitimod有可能成为第一个类固醇保留和疾病改善治疗结节病“。

“Oral corticosteroids remain the mainstay of treatment for patients with pulmonary sarcoidosis, although long-term treatment often comes with severe side effects and toxicity. Steroid tapers in these patients are challenging, as symptoms and FVC can worsen when steroid dose is reduced,” said Robert P.

“口服皮质类固醇仍然是肺结节病患者的主要治疗方法，尽管长期治疗往往伴随着严重的副作用和毒性，这些患者的类固醇逐渐减少是具有挑战性的，因为当类固醇剂量减少时症状和FVC会恶化，”罗伯特P。

Baughman, M.D., Professor of Medicine at the University of Cincinnati Medical Center. “This analysis demonstrating a relapse rate limited to 7.7% for the efzofitimod therapeutic group is exciting, as we would normally expect to see a relapse rate as high as approximately 50% over the course of 6 months, which is what was observed in the subtherapeutic group, and the difference may even be more evident in a longer study.

Baughman，医学博士，辛辛那提大学医学中心医学教授。“这项分析显示efzofitimod治疗组的复发率限制在7.7%是令人兴奋的，因为我们通常期望在6个月内复发率高达约50%，这是在亚治疗组，并且在更长的研究中差异可能更明显。

This is one of the few studies to demonstrate a steroid sparing effect of a drug associated with a significant improvement in patient outcome. A treatment such as efzofitimod that can reduce steroid burden is greatly needed.”.

这是为数不多的证明与患者预后显着改善相关的药物的类固醇保留作用的研究之一。非常需要一种可以减轻类固醇负担的治疗方法，例如efzofitimod。”。

Therapeutic Doses of Efzofitimod Significantly Improve Multiple Pulmonary Sarcoidosis Efficacy Measures

治疗剂量的Efzofitimod显着改善多种肺结节病疗效措施

The poster presents findings from a pooled, post-hoc analysis of data from a Phase 1b/2a randomized, double-blind, placebo-controlled, multiple ascending dose (1.0, 3.0 and 5.0 mg/kg) 24-week study of efzofitimod in patients with pulmonary sarcoidosis receiving oral corticosteroid (OCS) dose ≥ 10.0 mg/day.

海报展示了来自1b/2a期随机，双盲，安慰剂对照，多次递增剂量（1.0,3.0和5.0 mg/kg）24周efzofitimod研究数据的汇总事后分析结果接受口服皮质类固醇（OCS）剂量≥10.0mg/天的肺结节病患者。

Patients were randomized 1:2 (placebo:efzofitimod) and underwent a forced steroid taper in the first 8 weeks of the study. Dose dependent improvements in steroid burden, FVC and patient reported outcomes (PRO) were noted, though the study was not powered for efficacy..

患者随机1:2（安慰剂：efzofitimod），并在研究的前8周接受强迫类固醇锥度。注意到类固醇负荷，FVC和患者报告结局（PRO）的剂量依赖性改善，尽管该研究没有效力。。

In this pooled analysis, the 3.0 mg/kg (N=8) and 5.0 mg/kg (N=9) efzofitimod arms were considered therapeutic, and pooled. The placebo (N=12) and 1.0 mg/kg (N=8) efzofitimod arm, which was considered subtherapeutic, were pooled. Time to relapse for steroid use (defined as dose of OCS increased after OCS taper to 5.0 mg or less of prednisone or equivalent for at least five consecutive days), rate of change for FVC and proportion of patients with changes that are multiples of the minimally clinically important difference (MCID) in PRO (Kings Sarcoidosis Questionnaire-Lung, or KSQ-L) were compared.

在该汇总分析中，3.0mg/kg（N=8）和5.0mg/kg（N=9）efzofitimod臂被认为是治疗性的，并且汇集。合并被认为是亚治疗的安慰剂（N=12）和1.0mg/kg（N=8）efzofitimod组。类固醇使用复发的时间（定义为OCS减量至5.0 mg或更少泼尼松或相当于至少连续5天增加OCS的剂量），FVC的变化率和变化倍数比较PRO（Kings Sarcoidosis Questionnaire Lung，或KSQ-L）中最小临床重要差异（MCID）。

Additionally, a responder endpoint was proposed (defined as reduction in OCS from baseline without worsening in FVC or PRO) and an analysis was performed. Key findings include:.

此外，还提出了一个响应者终点（定义为从基线降低OC而不使FVC或PRO恶化）并进行分析。主要发现包括：。

7.7% of patients in the therapeutic group relapsed for steroid use compared to 54.4% of patients in the placebo/subtherapeutic group (p=0.017);

治疗组中7.7%的患者复发使用类固醇，而安慰剂/亚治疗组患者为54.4%（p=0.017）；

The rate of change for FVC was significantly improved for the therapeutic group compared to the placebo/subtherapeutic group (p=0.035);

与安慰剂/亚治疗组相比，治疗组FVC的变化率显着改善（p=0.035）；

52.9% of patients in the therapeutic group showed an increase ≥12 for KSQ-L (3 times MCID) compared with 15.0% in the placebo/subtherapeutic group (p=0.032); and

治疗组52.9%的患者KSQ-L增加≥12（MCID 3倍），安慰剂/亚治疗组为15.0%（p=0.032）；和

64.7% of patients in the therapeutic group achieved response compared to 20.0% in the placebo/subtherapeutic group (p=0.008).

治疗组中64.7%的患者获得了应答，而安慰剂/亚治疗组为20.0%（p=0.008）。

aTyr is currently conducting EFZO-FIT™, a global Phase 3 randomized, double-blind, placebo-controlled 52-week study to evaluate the efficacy and safety of 3.0 mg/kg and 5.0 mg/kg of efzofitimod in 264 patients with pulmonary sarcoidosis. The trial design incorporates a forced steroid taper. The primary endpoint of the study is steroid reduction.

aTyr目前正在进行EFZO-FIT™, 一项全球3期随机，双盲，安慰剂对照的52周研究，评估264例肺结节病患者中3.0 mg/kg和5.0 mg/kg efzofitimod的疗效和安全性。试验设计包括强制类固醇锥度。该研究的主要终点是类固醇减少。

Secondary endpoints include measures of lung function and sarcoidosis symptoms..

次要终点包括肺功能和结节病症状的测量。。

About Efzofitimod

关于Efzofitimod

Efzofitimod is a first-in-class biologic immunomodulator in clinical development for the treatment of interstitial lung disease (ILD), a group of immune-mediated disorders that can cause inflammation and fibrosis, or scarring, of the lungs. Efzofitimod is a tRNA synthetase derived therapy that selectively modulates activated myeloid cells through neuropilin-2 to resolve inflammation without immune suppression and potentially prevent the progression of fibrosis.

Efzofitimod是临床开发中用于治疗间质性肺病（ILD）的一流生物免疫调节剂，间质性肺病是一组可引起肺部炎症和纤维化或瘢痕形成的免疫介导的疾病。Efzofitimod是一种tRNA合成酶衍生疗法，可通过neuropilin-2选择性调节活化的髓样细胞，从而在没有免疫抑制的情况下解决炎症，并可能预防纤维化的进展。

aTyr is currently investigating efzofitimod in the global Phase 3 EFZO-FIT™ study in patients with pulmonary sarcoidosis, a major form of ILD, and in the Phase 2 EFZO-CONNECT™ study in patients with systemic sclerosis (SSc, or scleroderma)-related ILD. These forms of ILD have limited therapeutic options and there is a need for safer and more effective, disease-modifying treatments that improve outcomes..

aTyr目前正在全球第三阶段EFZO-FIT中研究efzofitimod™ 研究主要形式为ILD的肺结节病患者和2期EFZO-CONNECT患者™ 研究系统性硬化症（SSc或硬皮病）相关的ILD患者。这些形式的ILD的治疗选择有限，因此需要更安全，更有效的疾病缓解治疗方法来改善预后。。

About aTyr

关于aTyr

aTyr is a clinical stage biotechnology company leveraging evolutionary intelligence to translate tRNA synthetase biology into new therapies for fibrosis and inflammation. tRNA synthetases are ancient, essential proteins that have evolved novel domains that regulate diverse pathways extracellularly in humans.

aTyr是一家临床阶段的生物技术公司，利用进化智能将tRNA合成酶生物学转化为纤维化和炎症的新疗法。tRNA合成酶是古老的必需蛋白质，已进化出新的结构域，可调节人类细胞外的多种途径。

aTyr’s discovery platform is focused on unlocking hidden therapeutic intervention points by uncovering signaling pathways driven by its proprietary library of domains derived from all 20 tRNA synthetases. aTyr’s lead therapeutic candidate is efzofitimod, a first-in-class biologic immunomodulator in clinical development for the treatment of interstitial lung disease, a group of immune-mediated disorders that can cause inflammation and progressive fibrosis, or scarring, of the lungs.

aTyr的发现平台专注于通过揭示由其专有的来自所有20种tRNA合成酶的结构域库驱动的信号传导途径来解锁隐藏的治疗干预点。aTyr的主要治疗候选药物是efzofitimod，它是临床开发中用于治疗间质性肺病的一流生物免疫调节剂，间质性肺病是一组免疫介导的疾病，可引起肺部炎症和进行性纤维化或瘢痕形成。

For more information, please visit www.atyrpharma.com..

欲了解更多信息，请访问www.atyrpharma.com。。

Forward-Looking Statements

前瞻性声明

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 “believes,” “can,” “expects,” “intends,” “may,” “plans,” “potential,” “will,” and variations of such words or similar expressions.

本新闻稿包含1995年“私人证券诉讼改革法”含义内的前瞻性声明。前瞻性陈述通常通过使用诸如“相信”，“可以”，“期望”，“意图”，“可以”，“计划”，“潜力”，“将会”之类的单词或类似表达的变体来标识。

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, among others, statements regarding the potential of efzofitimod to provide a differentiated approach to resolving inflammation and preventing the progression of fibrosis to be the first steroid sparing and disease-modifying treatment for sarcoidosis and to reduce steroid burden and significantly improve multiple pulmonary sarcoidosis efficacy measures, and the potential applications of efzofitimod.

我们希望这些前瞻性声明受此类安全港条款对前瞻性声明的保护，并且为了遵守这些安全港条款而作出本声明。这些前瞻性陈述除其他外，还包括关于efzofitimod提供解决炎症和预防纤维化进展的差异化方法的潜力的陈述，这是结节病的第一种类固醇保留和疾病改善治疗方法，并减轻类固醇负担并显着改善多种肺结节病疗效指标，以及efzofitimod的潜在应用。

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, strategies or prospects will be attained or achieved.

这些前瞻性陈述也反映了我们目前对我们的计划，意图，期望，策略和前景的看法，这些观点是基于我们目前可获得的信息和我们所做的假设。虽然我们认为这些前瞻性陈述所反映或暗示的我们的计划，意图，期望，策略和前景是合理的，但我们不能保证计划，意图，期望，策略或前景将得到实现或实现。

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.

所有前瞻性陈述都是基于我们管理层的估计和假设，尽管我们认为这是合理的，但本质上是不确定的。此外，实际结果可能与这些前瞻性声明中描述的结果有很大不同，并将受到影响。

Contact:

联系方式：

Ashlee Dunston

阿什莉·邓斯顿

Director, Investor Relations and Public Affairs

投资者关系和公共事务总监

adunston@atyrpharma.com

adunston@atyrpharma.com