BOSTON--(BUSINESS WIRE)--PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) ('PureTech' or the 'Company'), a clinical-stage biotherapeutics company dedicated to changing the lives of patients with devastating diseases, today announced that enrollment has been completed in the ELEVATE IPF Phase 2b clinical trial evaluating LYT-100 (deupirfenidone) in patients with idiopathic pulmonary fibrosis (IPF)..

波士顿--（商业新闻短讯）--PureTech Health plc（纳斯达克：PRTC，伦敦证券交易所：PRTC）（“PureTech”或“公司”）是一家临床阶段的生物治疗公司，致力于改变毁灭性疾病患者的生活，今天宣布已完成REVATE IPF 2b期临床试验的注册，该试验评估了特发性肺纤维化（IPF）患者的LYT-100（去吡非尼酮）。。

LYT-100 is a deuterated form of pirfenidone, which is one of the two standard-of-care treatments, along with nintedanib, approved to treat IPF. Both pirfenidone and nintedanib are efficacious but associated with significant tolerability issues, contributing to approximately 75 percent of people with IPF in the U.S.

LYT-100是吡非尼酮的氘代形式，是两种标准治疗方法之一，与nintedanib一起被批准用于治疗IPF。吡非尼酮和nintedanib都是有效的，但与严重的耐受性问题有关，在美国约有75%的IPF患者。

choosing to forego treatment.1 LYT-100 is designed to address this unmet need by retaining the beneficial pharmacology and clinically-validated efficacy of pirfenidone with a highly differentiated pharmacokinetic (PK) profile. This PK profile and the resulting favorable tolerability have been demonstrated across multiple clinical trials in more than 400 individuals..

选择放弃治疗。1 LYT-100旨在通过保留吡非尼酮具有高度分化的药代动力学（PK）特征的有益药理学和临床验证功效来解决这一未满足的需求。这种PK谱和由此产生的良好耐受性已在400多个个体的多项临床试验中得到证实。。

“Despite the severity and progressive nature of IPF, there has been a dearth of successful therapeutic innovation since the approvals of pirfenidone and nintedanib nearly a decade ago,” said Toby Maher, M.D., Ph.D., Professor of Medicine and Director of Interstitial Lung Disease at Keck School of Medicine, University of Southern California, Los Angeles, and an investigator in the ELEVATE IPF trial.

“尽管IPF具有严重性和进步性，但自近十年前吡非尼酮和宁替达尼获得批准以来，成功的治疗创新一直缺乏，”Toby Maher医学博士、洛杉矶南加州大学凯克医学院医学教授和间质性肺病主任，以及ELEVATE IPF试验的研究者说。

“LYT-100 builds on the established efficacy of pirfenidone, and data generated to date suggest it may address key tolerability issues that prevent patients from starting or continuing treatment. LYT-100 has the potential to have a profound impact on the way IPF is managed by allowing patients to start, continue and fully benefit from treatment, both as monotherapy and in combination settings with other antifibrotic therapies.

“LYT-100建立在吡非尼酮既定疗效的基础上，迄今为止产生的数据表明它可能解决阻止患者开始或继续治疗的关键耐受性问题。LYT-100有可能对IPF的管理方式产生深远影响，允许患者开始，继续并充分受益于治疗，无论是作为单一疗法还是与其他抗纤维化疗法的联合治疗。

This milestone in the ELEVATE IPF trial is very exciting, and I look forward to the full results as a potential step forward for the large, underserved IPF patient community.”.

ELEVATE IPF试验中的这一里程碑非常令人兴奋，我期待着取得全面的结果，作为大型IPF患者社区向前迈出的潜在一步。”。

The Phase 2b ELEVATE IPF trial is a randomized, double-blind, placebo-controlled, dose-finding study designed to evaluate the efficacy, tolerability, safety and dosing regimen of LYT-100 in patients with IPF compared to placebo. The trial will also assess the relative efficacy of two doses of LYT-100.

2b期ELEVATE IPF试验是一项随机，双盲，安慰剂对照，剂量发现研究，旨在评估与安慰剂相比，LYT-100在IPF患者中的疗效，耐受性，安全性和给药方案。该试验还将评估两剂LYT-100的相对疗效。

Participants have been randomized in a ratio of 1:1:1:1 to receive either 550 mg of LYT-100, 825 mg of LYT-100, pirfenidone or placebo three times a day (TID) for up to 26 weeks and includes an optional open-label extension. The primary endpoint is the rate of decline in Forced Vital Capacity (FVC) for the combined LYT-100 arms versus placebo over the 26-week treatment period using a prespecified Bayesian approach.

参与者以1:1:1:1的比例随机接受550 mg LYT-100、825 mg LYT-100、吡非尼酮或安慰剂，每天三次（TID），最多26周，包括可选的开放标签扩展。主要终点是使用预先指定的贝叶斯方法，在26周的治疗期间，联合LYT-100组与安慰剂组的用力肺活量（FVC）下降率。

Other key endpoints include tolerability measures, biomarkers and patient-reported outcomes. Both doses of LYT-100 will be compared to pirfenidone, though the trial is not powered to show a statistical difference in efficacy between LYT-100 and pirfenidone. Topline results are expected in the fourth quarter of 2024..

其他关键终点包括耐受性测量，生物标志物和患者报告的结果。两种剂量的LYT-100都将与吡非尼酮进行比较，尽管该试验无法显示LYT-100和吡非尼酮之间疗效的统计学差异。Topline业绩预计将于2024年第四季度公布。。

PureTech has previously shared data from a crossover trial showing that a 550 mg dose of LYT-100 provided bioequivalent drug exposure to the FDA-approved dose of pirfenidone, 801 mg. This dose also achieved an approximately 50 percent reduction in participants experiencing gastro-intestinal (GI) and central nervous system (CNS)-related adverse events (AEs) compared to those taking pirfenidone.

PureTech之前分享了一项交叉试验的数据，该试验显示，550 mg剂量的LYT-100可使生物等效药物暴露于FDA批准剂量的801 mg吡非尼酮。与服用吡非尼酮的患者相比，该剂量的参与者经历胃肠道（GI）和中枢神经系统（CNS）相关不良事件（AE）的人数减少了约50%。

Additionally, the data showed that a higher dose of LYT-100 (824 mg TID), which achieved a 43 percent higher drug exposure level, was well-tolerated with no additional incidence of GI or CNS AEs when titrated up from LYT-100 550 mg TID. These results reinforce the potential for LYT-100 to provide enhanced efficacy with favorable tolerability in IPF.

此外，数据显示，从LYT-100每天三次每次550毫克滴定到更高剂量的LYT-100（每天三次824毫克），其药物暴露水平提高了43%，耐受性良好，没有额外的胃肠道或中枢神经系统AE发生率。这些结果增强了LYT-100在IPF中提供具有良好耐受性的增强功效的潜力。

This hypothesis is supported by Phase 3 data with pirfenidone that showed a dose-response effect on forced vital capacity and survival in people with IPF.2 PureTech is therefore investigating the efficacy and tolerability of LYT-100 at 550 mg TID and 825 mg TID in the Phase 2b ELEVATE IPF trial..

吡非尼酮的第3阶段数据支持了这一假设，该数据显示了对IPF患者的强迫肺活量和生存率的剂量反应效应。因此，PureTech正在研究LYT-100在第2b期ELEVATE IPF试验中550 mg TID和825 mg TID的疗效和耐受性。。

PureTech plans to pursue a streamlined development program for LYT-100 in IPF and is using the same validated endpoints that have supported past antifibrotic approvals. PureTech believes the results of the Phase 2b trial, together with an additional Phase 3 trial, could serve as the basis for registration in the U.S.

PureTech计划在IPF中推行LYT-100的简化开发计划，并使用与过去抗纤维化批准相同的经过验证的终点。PureTech认为，2b期试验的结果以及另外的3期试验可以作为在美国注册的基础。

and other geographies..

和其他地理位置。。

PureTech would like to extend its gratitude to those participating in the ELEVATE IPF trial, especially the people living with IPF and their caregivers, the clinical trial sites, investigators and advocacy groups.

PureTech谨向参与ELEVATE IPF试验的人员表示感谢，特别是IPF患者及其护理人员、临床试验地点、调查人员和倡导团体。

About Idiopathic Pulmonary Fibrosis (IPF)

关于特发性肺纤维化（IPF）

IPF is a rare, progressive and fatal lung disease with a median survival of 2-5 years.3 Pirfenidone is one of only two drugs approved to treat IPF, and for those patients able to tolerate treatment, it has been shown to improve survival by approximately 2.5 years compared to supportive care alone.3 However, tolerability issues with both of the standard-of-care drugs result in patients discontinuing treatment or reducing their dose.

IPF是一种罕见的，进行性和致命的肺部疾病，中位生存期为2-5年。吡非尼酮是仅有的两种被批准用于治疗IPF的药物之一，对于那些能够耐受治疗的患者，与单独支持治疗相比，它已被证明可将生存期提高约2.5年。然而，两种标准治疗药物的耐受性问题导致患者停止治疗或减少剂量。

This contributes to nearly three out of every four people with IPF choosing to forego treatment with these otherwise efficacious medicines.1.

这有助于近四分之三的IPF患者选择放弃这些其他有效药物的治疗。

About LYT-100 (Deupirfenidone)

关于LYT-100（Depirfenidone）

LYT-100 (deupirfenidone) is being advanced for the treatment of conditions involving inflammation and fibrosis, including IPF. It is a deuterated form of pirfenidone that is designed to retain the beneficial pharmacology and clinically-validated efficacy of pirfenidone with a highly differentiated PK profile.

LYT-100（去吡非尼酮）正在用于治疗涉及炎症和纤维化的疾病，包括IPF。它是吡非尼酮的氘代形式，旨在保留吡非尼酮的有益药理学和临床验证功效，具有高度分化的PK谱。

This PK profile has translated into favorable tolerability as demonstrated across multiple clinical studies in more than 400 individuals..

这种PK谱已转化为良好的耐受性，如400多个个体的多项临床研究所证明的。。

Pirfenidone is one of the two standard-of-care treatments approved for IPF, along with nintedanib, both of which are efficacious but associated with significant tolerability issues. These tolerability issues result in treatment discontinuations and/or dose reductions below the FDA-approved dose, thereby limiting the effectiveness of these otherwise efficacious medicines.

吡非尼酮是IPF批准的两种标准治疗方法之一，与nintedanib一起使用，两者都是有效的，但与严重的耐受性问题有关。这些耐受性问题导致治疗中断和/或剂量减少低于FDA批准的剂量，从而限制了这些其他有效药物的有效性。

With LYT-100, PureTech aims to deliver better outcomes for patients by enabling individuals to maintain the same or higher pirfenidone-equivalent doses for longer. PureTech believes LYT-100 has the potential both to supplant the current standard-of-care treatments and to serve a larger market of patients who are unable to tolerate current therapies..

使用LYT-100，PureTech旨在通过使患者能够更长时间维持相同或更高的吡非尼酮等效剂量，为患者提供更好的结果。PureTech认为LYT-100既有可能取代目前的标准护理治疗，也有可能为无法忍受当前治疗的更大市场的患者提供服务。。

About PureTech Health

关于PureTech Health

PureTech is a clinical-stage biotherapeutics company dedicated to giving life to new classes of medicine to change the lives of patients with devastating diseases. The Company has created a broad and deep pipeline through its experienced research and development team and its extensive network of scientists, clinicians and industry leaders that is being advanced both internally and through its Founded Entities.

PureTech是一家临床阶段的生物治疗公司，致力于为新型药物注入活力，以改变毁灭性疾病患者的生活。该公司通过其经验丰富的研发团队以及由科学家、临床医生和行业领导者组成的广泛网络，建立了广泛而深入的渠道，这些网络正在内部和通过其成立的实体进行改进。

PureTech's R&D engine has resulted in the development of 28 therapeutics and therapeutic candidates, including two that have received both U.S. FDA clearance and European marketing authorization and a third (KarXT) that has been filed for FDA approval. A number of these programs are being advanced by PureTech or its Founded Entities in various indications and stages of clinical development, including registration enabling studies.

PureTech的研发引擎开发了28种治疗药物和候选治疗药物，其中两种已获得美国FDA批准和欧洲上市授权，第三种（KarXT）已提交FDA批准。PureTech或其成立的实体正在临床开发的各个适应症和阶段推进许多这些计划，包括注册支持研究。

All of the underlying programs and platforms that resulted in this pipeline of therapeutic candidates were initially identified or discovered and then advanced by the PureTech team through key validation points..

PureTech团队最初确定或发现了导致这一候选治疗药物管道的所有基础程序和平台，然后通过关键验证点进行了改进。。

For more information, visit www.puretechhealth.com or connect with us on X (formerly Twitter) @puretechh.

有关更多信息，请访问www.puretechhealth.com或通过X（以前的Twitter）@puretechh与我们联系。

Cautionary Note Regarding Forward-Looking Statements

关于前瞻性声明的警示说明

This press release contains statements that are or may be forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation those related to the LYT-100 development program and development plans and the timing for results from ongoing clinical trials of LYT-100, and our future prospects, developments and strategies.

本新闻稿包含的声明是或可能是1995年《私人证券诉讼改革法案》所指的前瞻性声明。本新闻稿中包含的所有与历史事实无关的声明均应视为前瞻性声明，包括但不限于与LYT-100开发计划和开发计划有关的声明，以及正在进行的LYT-100临床试验结果的时间安排，以及我们未来的前景，发展和战略。

The forward-looking statements are based on current expectations and are subject to known and unknown risks, uncertainties and other important factors that could cause actual results, performance and achievements to differ materially from current expectations, including, but not limited to, those risks, uncertainties and other important factors described under the caption 'Risk Factors' in our Annual Report on Form 20-F for the year ended December 31, 2022 filed with the SEC and in our other regulatory filings.

前瞻性陈述基于当前预期，并受到已知和未知的风险、不确定性和其他重要因素的影响，这些风险、不确定性和其他重要因素可能导致实际结果、绩效和成就与当前预期存在重大差异，包括但不限于我们向SEC提交的表20-F年度报告和其他监管文件中“风险因素”标题下描述的风险、不确定性和其他重要因素。

These forward-looking statements are based on assumptions regarding the present and future business strategies of the Company and the environment in which it will operate in the future. Each forward-looking statement speaks only as at the date of this press release. Except as required by law and regulatory requirements, we disclaim any obligation to update or revise these forward-looking statements, whether as a result of new information, future events or otherwise..

这些前瞻性陈述基于对公司当前和未来业务战略及其未来运营环境的假设。每个前瞻性声明仅在本新闻稿发布之日起生效。除法律和监管要求外，我们不承担因新信息、未来事件或其他原因而更新或修订这些前瞻性声明的任何义务。。

1 Dempsey, T., Payne, S. C., Sangaralingham, L. R., Yao, X., Shah, N., & Limper, A. H. (2021). Adoption of the Antifibrotic Medications Pirfenidone and Nintedanib for Patients with Idiopathic Pulmonary Fibrosis. Annals of the American Thoracic Society, 18(7), 1121–1128. https://doi.org/10.1513/annalsats.202007-901oc .

1邓普西，T.，佩恩，S.C.，桑加林厄姆，L.R.，姚，X.，沙阿，N.，和林珀，A.H.（2021）。特发性肺纤维化患者采用抗纤维化药物吡非尼酮和Nintedanib。美国胸科学会年鉴，18（7），1121-1128。https://doi.org/10.1513/annalsats.202007-901oc。

2 King, T. E., Bradford, W. Z., Castro-Bernardini, S., Fagan, E. A., Glaspole, I., Glassberg, M. K., Gorina, E., Hopkins, P., Kardatzke, D., Lancaster, L., Lederer, D. J., Nathan, S. D., De Castro Pereira, C. A., Sahn, S. A., Sussman, R., Swigris, J. J., & Noble, P. W. (2014). A Phase 3 Trial of Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis.

2 King，T.E.，Bradford，W.Z.，Castro Bernardini，S.，Fagan，E.A.，Glaspole，I.，Glassberg，M.K.，Gorina，E.，Hopkins，P.，Kardatzke，D.，Lancaster，L.，Lederer，D.J.，Nathan，S.D.，De Castro Pereira，C.A.，Sahn，S.A.，Sussman，R.，Swigris，J.J.，＆Noble，P.W.（2014）。吡非尼酮治疗特发性肺纤维化患者的3期临床试验。

The New England Journal of Medicine, 370(22), 2083-2092. https://doi.org/10.1056/nejmoa1402582 .

《新英格兰医学杂志》，370（22），2083-2092。https://doi.org/10.1056/nejmoa1402582.

3 Fisher, M., Nathan, S. D., Hill, C., Marshall, J., Dejonckheere, F., Thuresson, P., & Maher, T. M. (2017). Predicting Life Expectancy for Pirfenidone in Idiopathic Pulmonary Fibrosis. Journal of Managed Care & Specialty Pharmacy, 23(3-b Suppl), S17-S24. https://doi.org/10.18553/jmcp.2017.23.3-b.s17.

3 Fisher，M.，Nathan，S.D.，Hill，C.，Marshall，J.，Dejonckheere，F.，Thuresson，P.，＆Maher，T.M.（2017）。预测吡非尼酮在特发性肺纤维化中的预期寿命。管理护理与专科药学杂志，23（3-b Suppl），S17-S24。https://doi.org/10.18553/jmcp.2017.23.3-b.s17.