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MorphoSys AG: MorphoSys Expects Topline Data From Phase 3 Study of Pelabresib in Myelofibrosis in Early 2024

MorphoSys AG: MorphoSys Expects Topline Data From Phase 3 Study of Pelabresib in Myelofibrosis in Early 2024

Morphosys AG:Morphosys预计2024年初Pelabresb治疗骨髓纤维化的3期研究的Topline数据
Accesswire ·  2023/01/09 01:22

MUNICH, GERMANY / ACCESSWIRE / January 9, 2023 / MorphoSys AG (FSE: MOR; NASDAQ: MOR) announced today that topline data from the ongoing Phase 3 MANIFEST-2 study - a global, randomized, double-blind clinical trial exploring pelabresib, an investigational BET inhibitor, in combination with ruxolitinib as a first-line treatment for patients with myelofibrosis - are expected to be available in early 2024. The company previously communicated that these data were expected in the first half of 2024. Jean-Paul Kress, M.D., Chief Executive Officer of MorphoSys, will provide further updates on the pelabresib program and the rest of the company's oncology pipeline at the 41st Annual J.P. Morgan Healthcare Conference on Wednesday, January 11, 2023, at 5:15 p.m. Pacific Standard Time in San Francisco, CA.

德国慕尼黑/ACCESSWIRE/2023年1月9日/Morphosys AG(法兰克福证券交易所市场代码:MOR;纳斯达克:MOR)今天宣布,正在进行的3期MANIFEST-2研究的主要数据预计将于2024年初上市。MANIFEST-2研究是一项全球性、随机、双盲临床试验,探索贝伐他汀抑制剂贝拉贝利与鲁索利替尼联合作为治疗骨髓纤维化患者的一线药物。该公司此前曾表示,这些数据预计将在2024年上半年发布。MorPhoSys公司首席执行官Jean-Paul Kress医学博士将在2023年1月11日(星期三)下午5点15分举行的第41届J.P.摩根医疗会议上提供关于Pelabresb计划和该公司其他肿瘤学计划的进一步更新。加州旧金山的太平洋标准时间。

"For patients with myelofibrosis, depth and durability of responses are limited with current first-line therapy. The latest Phase 2 data suggest pelabresib may have the potential to enhance the standard of care, reaffirming our confidence in the Phase 3 MANIFEST-2 study," said Jean-Paul Kress. "We look forward to providing further updates on the pelabresib program and our other clinical programs during the J.P. Morgan Healthcare Conference."

Jean-Paul Kress说:“对于骨髓纤维化患者,目前一线治疗的反应深度和持久性有限。最新的第二阶段数据表明,Pelabresb可能具有提高护理标准的潜力,重申了我们对第三阶段MANIFEST-2研究的信心。”我们期待着在摩根大通医疗保健会议期间提供关于Pelabresb计划和我们的其他临床计划的进一步更新。“

To view and listen to a live webcast of the presentation, visit MorphoSys' website at . The presentation and a replay of the webcast will also be available on the company's website.

要观看和收听演示文稿的网络直播,请访问MorPhoSys的网站:。演示文稿和网络直播的重播也将在该公司的网站上观看。

About MorphoSys

关于MorPhoSys

At MorphoSys, we are driven by our mission: More life for people with cancer . As a global commercial-stage biopharmaceutical company, we use groundbreaking science and technologies to discover, develop, and deliver innovative cancer medicines to patients. MorphoSys is headquartered in Planegg, Germany, and has its U.S. operations anchored in Boston, Massachusetts. To learn more, visit us at and follow us on Twitter and LinkedIn .

在MorPhoSys,我们的动力来自我们的使命:为癌症患者提供更多的生命。作为一家全球商业阶段的生物制药公司,我们使用突破性的科学和技术来发现、开发和向患者提供创新的抗癌药物。Morphosys总部设在德国的普兰格,其美国业务的总部设在马萨诸塞州的波士顿。要了解更多信息,请访问我们,并在Twitter和LinkedIn上关注我们。

About Pelabresib
Pelabresib (CPI-0610) is an investigational selective small molecule designed to promote anti-tumor activity by inhibiting the function of bromodomain and extra-terminal domain (BET) proteins to decrease the expression of abnormally expressed genes in cancer. Pelabresib is being investigated as a treatment for myelofibrosis and has not yet been evaluated or approved by any regulatory authorities.

关于佩拉布利布
Pelabresb(CPI-0610)是一种研究中的选择性小分子,旨在通过抑制溴结构域和末端外结构域(BET)蛋白的功能来减少癌症中异常表达的基因的表达,从而促进抗肿瘤活性。Pelabreb作为治疗骨髓纤维化的药物正在接受研究,尚未得到任何监管机构的评估或批准。

About Myelofibrosis

关于骨髓纤维化

Myelofibrosis is a type of bone marrow cancer that causes extensive scarring in the bone marrow, which disrupts the body's normal production of healthy blood cells. The result is a reduction in red blood cells, which can cause weakness and fatigue, and in platelets, which increases the risk of bleeding due to deficient clotting. Myelofibrosis often causes an enlarged spleen, significantly impacting a patient's quality of life. It is most often diagnosed in people older than 50 and can occur on its own (called primary myelofibrosis) or because of another bone marrow disorder.

骨髓纤维化是一种骨髓癌,会在骨髓中造成广泛的疤痕,扰乱身体正常生产健康血细胞。其结果是红细胞和血小板的减少,前者会导致虚弱和疲劳,后者会增加由于凝血不足而出血的风险。骨髓纤维化通常会导致脾肿大,严重影响患者的生活质量。它最常在50岁以上的人群中被诊断出来,可以自行发生(称为原发性骨髓纤维化),也可以因为其他骨髓疾病而发生。

About MANIFEST-2

关于MANIFEST-2

MANIFEST-2 (NCT04603495) is a global, double-blind, randomized Phase 3 clinical trial with pelabresib in combination with ruxolitinib versus placebo plus ruxolitinib in JAK inhibitor-naïve patients with myelofibrosis. The primary endpoint of the study is a 35% or greater reduction in spleen volume (SVR35) from baseline at 24 weeks. A key secondary endpoint of the study is a 50% or greater improvement in total symptom score (TSS50) from baseline at 24 weeks. Constellation Pharmaceuticals, Inc., a MorphoSys company, is the MANIFEST-2 trial sponsor.

MANIFEST-2(NCT04603495)是一项全球性、双盲、随机的3期临床试验,使用培拉贝利联合鲁索利替尼与安慰剂加鲁索利替尼治疗JAK抑制剂-NAÏVE伴骨髓纤维化患者。研究的主要终点是在24周时脾体积(SVR35)比基线减少35%或更多。这项研究的一个关键次要终点是在24周时总症状评分(TSS50)比基线改善50%或更多。Morphy Sys公司旗下的星座制药公司是MANIFEST-2试验的赞助商。

Forward Looking Statements

前瞻性陈述

This communication contains certain forward-looking statements concerning the MorphoSys group of companies. The forward-looking statements contained herein represent the judgment of MorphoSys as of the date of this release and involve known and unknown risks and uncertainties, which might cause the actual results, financial condition and liquidity, performance or achievements of MorphoSys, or industry results, to be materially different from any historic or future results, financial conditions and liquidity, performance or achievements expressed or implied by such forward-looking statements. In addition, even if MorphoSys' results, performance, financial condition and liquidity, and the development of the industry in which it operates are consistent with such forward-looking statements, they may not be predictive of results or developments in future periods. Among the factors that may result in differences are that MorphoSys' expectations may be incorrect, the inherent uncertainties associated with competitive developments, clinical trial and product development activities and regulatory approval requirements, MorphoSys' reliance on collaborations with third parties, estimating the commercial potential of its development programs and other risks indicated in the risk factors included in MorphoSys' Annual Report on Form 20-F and other filings with the U.S. Securities and Exchange Commission. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. These forward-looking statements speak only as of the date of publication of this document. MorphoSys expressly disclaims any obligation to update any such forward-looking statements in this document to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements, unless specifically required by law or regulation.

本新闻稿包含有关MorPhoSys集团公司的某些前瞻性陈述。本新闻稿中包含的前瞻性陈述代表MorPhoSys截至本新闻稿发布之日的判断,涉及已知和未知的风险和不确定因素,可能会导致MorPhoSys的实际结果、财务状况和流动性、业绩或成就或行业结果与此类前瞻性陈述明示或暗示的任何历史或未来结果、财务状况和流动性、业绩或成就大不相同。此外,即使MorPhoSys的业绩、业绩、财务状况和流动性,以及它所经营的行业的发展与这些前瞻性陈述一致,它们也可能不能预测未来的结果或发展。可能导致差异的因素包括:MorPhoSys的预期可能是不正确的,与竞争开发、临床试验和产品开发活动以及监管批准要求相关的内在不确定性,MorPhoSys对与第三方合作的依赖,对其开发计划的商业潜力的估计,以及MorPhoSys提交给美国证券交易委员会的20-F表格年度报告和其他文件中包括的风险因素中指出的其他风险。鉴于这些不确定性,建议读者不要过度依赖此类前瞻性陈述。这些前瞻性陈述仅代表截至本文件发表之日的情况。Morphosys明确表示没有义务更新本文件中的任何此类前瞻性陈述,以反映其对此的任何预期变化或事件的任何变化, 任何此类陈述所依据的条件或情况,或可能影响实际结果与前瞻性陈述中陈述的结果不同的可能性,除非法律或法规特别要求。

For more information, please contact:

如需更多信息,请联系:

MorphoSys

睡眠症

Media Contacts:
Thomas Biegi
Vice President
Tel.: +49 (0)89 / 89927 26079
thomas.biegi@morphosys.com

媒体联系人:
托马斯·比吉
美国副总统
电话:+49(0)89/89927 26079
邮箱:thomas.biegi@morosys.com

Investor Contacts:
Dr. Julia Neugebauer
Head of Investor Relations
Tel: +49 (0)89 / 899 27 179
julia.neugebauer@morphosys.com

投资者联系方式:
朱莉娅·纽格鲍尔博士
投资者关系主管
电话:+49(0)89/899 27179
邮箱:julia.neugebauer@morosys.com

Eamonn Nolan
Director
Tel: +1 617-548-9271
eamonn.nolan@morphosys.com

埃蒙·诺兰
董事
电话:+1617-548-9271
邮箱:eamonn.nolan@morosys.com

SOURCE: MorphoSys AG

资料来源:Morphosys公司


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