Long term follow-up from REVIVE Phase 2 study up to 3 years shows durable hematocrit (Hct) control (< 45%), decreased phlebotomy use, long-term tolerability, and no new safety signals in patients with polycythemia vera

从REVIVE 2期研究到3年的长期随访显示，真性红细胞增多症患者的红细胞压积（Hct）持续控制（<45%），静脉切开术使用减少，长期耐受性降低，并且没有新的安全信号

Patients receiving rusfertide in the open-label extension of the REVIVE study are eligible to roll over to the THRIVE study for an additional 2 years of treatment

在REVIVE研究的开放标签扩展中接受rusfertide治疗的患者有资格转入THRIVE研究，再接受2年的治疗

NEWARK, CA / ACCESSWIRE / June 14, 2024 / Protagonist Therapeutics, Inc. ('Protagonist' or the 'Company') announced details from two abstracts at the European Hematology Association 2024 Congress, including an oral presentation with long-term follow-up data from the Phase 2 REVIVE study with rusfertide, a mimetic of the natural hormone hepcidin with potential therapeutic value in the treatment of polycythemia vera (PV) and other disease indications.

加利福尼亚州纽瓦克/ACCESSWIRE/2024年6月14日/Protation Therapeutics，Inc.（“Protation”或“公司”）宣布了欧洲血液学协会2024年大会上两篇摘要的细节，包括一篇口头报告，其中包含来自rusfertide的2期REVIVE研究的长期随访数据，rusfertide是天然激素hepcidin的模拟物，在治疗真性红细胞增多症（PV）和其他疾病适应症方面具有潜在的治疗价值。

Copies of the presentations will be available on the Events and Presentations section of the Protagonist website..

演示文稿的副本将在主角网站的活动和演示部分提供。。

Kristen M. Pettit, M.D., Clinical Associate Professor at University of Michigan Health presented the long-term follow-up data from patients in REVIVE who continued into the open label extension (OLE). The Phase 2 trial consisted of 3 parts including 70 patients in the dose-finding Part 1 (28 weeks), 59 patients in the placebo-controlled, randomized withdrawal Part 2 (13 weeks), and 58 patients in the Part 3 OLE (52 weeks).

密歇根大学健康学院临床副教授克里斯汀·佩蒂特（KristenM.Pettit）医学博士介绍了REVIVE患者继续使用开放标签扩展（OLE）的长期随访数据。第二阶段试验由3部分组成，包括剂量发现第1部分（28周）的70名患者，安慰剂对照，随机戒断第2部分（13周）的59名患者和第3部分OLE（52周）的58名患者。

The THRIVE study provides OLE for an additional two years of treatment to patients who have completed Part 3 OLE of the Phase 2 REVIVE study. As of April 9, 2024 (data cut-off for the EHA presentation), 47 patients (81.0%) remain on rusfertide, with 48 patients treated for two or more years and 10 patients treated for three or more years.

THRIVE研究为完成2期REVIVE研究第3部分OLE的患者提供了额外两年的OLE治疗。截至2024年4月9日（EHA报告的数据截止），47名患者（81.0%）仍在使用rusfertide，其中48名患者接受了两年或更长时间的治疗，10名患者接受了三年或更长时间的治疗。

Of the 58 patients who entered the REVIVE Part 3 OLE, the median duration of therapy is 124.3 weeks as of the April 9, 2024 data cut-off, and 24 patients have rolled over to the THRIVE study for up to two additional years of rusfertide treatment..

在进入REVIVE第3部分OLE的58名患者中，截至2024年4月9日数据截止，治疗的中位持续时间为124.3周，24名患者已转入THRIVE研究，最多再接受两年的rusfertide治疗。。

'These long-term REVIVE data continue to showcase the positive clinical impact that rusfertide has on PV patients,' noted Dr. Kristen M. Pettit. 'With up to three years of data showing strong and lasting improvements in hematocrit as well as previous evidence of symptom improvement, rusfertide continues to demonstrate its potential as an important future treatment option for patients with polycythemia vera.'.

克里斯汀·M·佩蒂特（KristenM.Pettit）博士指出：“这些长期的REVIVE数据继续展示了rusfertide对PV患者的积极临床影响。”随着长达三年的数据显示血细胞比容的持续改善以及之前症状改善的证据，rusfertide继续证明其作为真性红细胞增多症患者未来重要治疗选择的潜力。

The updated long-term data showed that rusfertide when added to therapeutic phlebotomy with or without cytoreductive therapy resulted in:

最新的长期数据显示，在有或没有细胞减灭治疗的情况下，将rusfertide加入治疗性静脉切开术中会导致：

Long term durable control of hematocrit below the 45% threshold for up to 3 years

长期持久控制血细胞比容低于45%阈值长达3年

Decreased phlebotomy use, from a rate of 8.7 per year before study entry to 0.43 per year in Part 3 of REVIVE, which remained consistent with the rate of 0.36 per year observed for patients randomized to rusfertide in Part 2 of REVIVE

减少了静脉切开术的使用，从研究开始前的每年8.7次减少到REVIVE第3部分的每年0.43次，这与REVIVE第2部分随机接受rusfertide治疗的患者每年0.36次的使用率保持一致

Decreased red blood cell counts and continued improvement and normalization of serum ferritin levels

红细胞计数减少，血清铁蛋白水平持续改善和正常化

Mean leukocyte counts remained stable throughout the study; an asymptomatic increase in platelets was observed with initiation of rusfertide treatment but stabilized over time

在整个研究过程中，平均白细胞计数保持稳定；开始使用rusfertide治疗后，观察到血小板无症状增加，但随着时间的推移稳定下来

No new safety signals with the majority of adverse events being Grade 1-2 injection site reactions or adverse events consistent with the comorbidities commonly associated with polycythemia vera

没有新的安全信号，大多数不良事件是1-2级注射部位反应或不良事件，与通常与真性红细胞增多症相关的合并症一致

In REVIVE, 19 of 70 patients (27.1%) had a history of cancer prior to enrolling in the study. Among these, 10 (14.3%) had a history of skin cancer. As of April 9, 2024, there are 11 patients diagnosed with malignancies while on study (11/70; 15.7%), including 9 with skin cancer (9/70; 12.9%). All cancers occurred in patients with risk factors such as a prior history of cancer, previous cytoreductive therapy, pre-existing skin lesions that were not biopsied or photosensitive skin.

在REVIVE中，70名患者中有19名（27.1%）在参加研究之前有癌症史。其中，有10名（14.3%）有皮肤癌病史。截至2024年4月9日，有11名患者在研究期间被诊断出患有恶性肿瘤（11/70；15.7%），其中9名患有皮肤癌（9/70；12.9%）。所有癌症均发生在具有危险因素的患者中，例如既往癌症史，既往细胞减灭疗法，既往未活检的皮肤病变或光敏性皮肤。

All skin cancers were localized, early stage (in situ or stage 1) and all patients remained on rusfertide after the skin lesions were excised..

所有皮肤癌都是局部的，早期（原位或1期），所有患者在切除皮肤病变后仍服用rusfertide。。

'The long-term open label rusfertide data from REVIVE study continue to show a durable positive effect on PV symptomology and other benefits including iron deficiency as well as a solid safety profile. Patients completing the 3-year open-label extension can roll over to the THRIVE open-label study for an additional 2-years providing efficacy and safety for a total of up to 5.8 years of rusfertide treatment,' said Arturo Molina, M.D., M.S., Chief Medical Officer of Protagonist.

“REVIVE研究的长期开放标签rusfertide数据继续显示出对PV症状和其他益处（包括缺铁）的持久积极影响以及可靠的安全性。PROTAGITOR首席医疗官、医学博士、医学硕士阿图罗·莫利纳（ArturoMolina）说，完成3年开放标签延长的患者可以再转入THRIVE开放标签研究2年，为总共5.8年的rusfertide治疗提供有效性和安全性。

'We are very pleased with the continued favorable safety profile and look forward to the top-line data for the VERIFY Phase 3 study's 32-week primary efficacy endpoint by the end of the first quarter of 2025.'.

“我们对持续良好的安全性状况感到非常满意，并期待在2025年第一季度结束前获得VERIFY 3期研究32周主要疗效终点的顶线数据。”。

A separate abstract accepted for publication only was titled 'Absence of QTC Prolongation with Rusfertide, a Hepcidin Mimetic for the Treatment of Polycythemia Vera: A Thorough QT/QTC Study in Healthy Subjects.' In this study, 60 healthy subjects were randomized to receive single doses of subcutaneous rusfertide (90mg), matching placebo, or oral moxifloxacin (400mg).Rusfertide was generally well tolerated and did not result in a clinically relevant prolongation of the QTcF interval..

另一篇仅被接受发表的摘要标题为“用于治疗真性红细胞增多症的铁调素模拟物Rusfertide不存在QTC延长：对健康受试者进行全面的QT/QTC研究”在这项研究中，60名健康受试者被随机分配接受单剂量皮下注射rusfertide（90mg），匹配安慰剂或口服莫西沙星（400mg）。Rusfertide通常耐受性良好，不会导致QTcF间隔的临床相关延长。。

About Protagonist

关于主角

Protagonist Therapeutics is a biopharmaceutical company with peptide-based new chemical entities (NCEs) rusfertide and JNJ-2113 (formerly PN-235) in advanced stages of clinical development, both derived from the Company's proprietary technology platform. Protagonist and JNJ scientists jointly discovered PN-235 (now known as JNJ-2113) as part of Protagonist's Interleukin-23 receptor (IL-23R) collaboration with JNJ and followed it through IND-enabling pre-clinical and Phase 1 studies, with JNJ assuming responsibility for further clinical development.

Protation Therapeutics是一家生物制药公司，其基于肽的新化学实体（NCE）rusfertide和JNJ-2113（以前称为PN-235）处于临床开发的晚期，均来自该公司的专有技术平台。Protation和JNJ科学家共同发现了PN-235（现在称为JNJ-2113），作为Protation与JNJ合作的白细胞介素23受体（IL-23R）的一部分，并通过IND进行了临床前和1期研究，JNJ承担了进一步临床开发的责任。

Rusfertide, a mimetic of the natural hormone hepcidin, is the Company's lead drug candidate currently in a global Phase 3 development program. The randomized portion of the Phase 2 REVIVE study was unblinded, showing positive results and is now complete, with an open-label extension underway. The global Phase 3 VERIFY study of rusfertide in polycythemia vera is ongoing.

Rusfertide是天然激素hepcidin的模拟物，是该公司目前正在进行全球第三阶段开发计划的主要候选药物。第二阶段REVIVE研究的随机部分是非盲的，显示出积极的结果，现在已经完成，正在进行开放标签的扩展。rusfertide在真性红细胞增多症中的全球3期验证研究正在进行中。

Rusfertide will be co-developed and co-commercialized with Takeda pursuant to a worldwide collaboration and license agreement with Takeda entered into in January 2024 and became effective in March 2024..

根据2024年1月与武田签订并于2024年3月生效的全球合作和许可协议，Rusfertide将与武田共同开发和共同商业化。。

More information on Protagonist, its pipeline drug candidates and clinical studies can be found on the Company's website at www.protagonist-inc.com.

有关Protation及其候选药物和临床研究的更多信息，请访问该公司的网站www.protation-inc.com。

Cautionary Note on Forward-Looking Statements

关于前瞻性陈述的警示说明

This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements regarding the potential benefits of rusfertide. In some cases, you can identify these statements by forward-looking words such as 'anticipate,' 'believe,' 'may,' 'will,' 'expect,' or the negative or plural of these words or similar expressions.

本新闻稿包含1995年《私人证券诉讼改革法案》安全港条款的前瞻性声明。前瞻性声明包括关于rusfertide潜在益处的声明。在某些情况下，您可以通过前瞻性词语来识别这些陈述，例如“预期”，“相信”，“可能”，“将”，“预期”，或者这些词语或类似表达的否定或复数。

Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated, including, but not limited to, our ability to develop and commercialize our product candidates, our ability to earn milestone payments under our collaboration agreement with Janssen, our ability to use and expand our programs to build a pipeline of product candidates, our ability to obtain and maintain regulatory approval of our product candidates, our ability to operate in a competitive industry and compete successfully against competitors that have greater resources than we do, and our ability to obtain and adequately protect intellectual property rights for our product candidates.

前瞻性陈述并不能保证未来的业绩，并且可能会产生风险和不确定性，这些风险和不确定性可能导致实际结果和事件与预期产生重大差异，包括但不限于我们开发和商业化候选产品的能力，我们根据与杨森的合作协议获得里程碑付款的能力，我们使用和扩展我们的计划以构建候选产品渠道的能力，我们获得和维持候选产品监管批准的能力，我们在竞争性行业中的运营能力以及与比我们拥有更多资源的竞争对手成功竞争的能力，以及我们获得和充分保护候选产品知识产权的能力。

Additional information concerning these and other risk factors affecting our business can be found in our periodic filings with the Securities and Exchange Commission, including under the heading 'Risk Factors' contained in our most recently filed periodic reports on Form 10-K and Form 10-Q filed with the Securities and Exchange Commission.

有关影响我们业务的这些风险因素和其他风险因素的其他信息，请参阅我们向证券交易委员会提交的定期文件，包括我们最近提交的定期报告中的“风险因素”标题下的信息，这些定期报告是在向证券交易委员会提交的表格10-K和表格10-Q中提交的。

Forward-looking statements are not guarantees of future performance, and our actual results of operations, financial condition and liquidity, and the development of the industry in which we operate, may differ materially .

前瞻性报表并不能保证未来的业绩，我们的实际经营业绩、财务状况和流动性以及我们经营的行业的发展可能存在重大差异。

Investor Relations Contact

投资者关系联系人

Corey Davis, Ph.D.

科里·戴维斯博士。

LifeSci Advisors

LifeSci顾问

+1 212 915 2577

+1 212 915 2577

cdavis@lifesciadvisors.com

cdavis@lifesciadvisors.com

Media Relations Contact

媒体关系联系人

Virginia Amann

弗吉尼亚·阿曼

ENTENTE Network of Companies

公司协约网络

virginiaamann@ententeinc.com

virginiaamann@ententeinc.com

+1 833 500 0061

+1 833 500 0061

SOURCE: Protagonist Therapeutics, Inc.

资料来源：Protation Therapeutics，Inc。

View the original press release on accesswire.com

在accesswire.com上查看原始新闻稿