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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預計2024年初Pelabresb治療骨髓纖維化的3期研究的Topline數據
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.

德國慕尼黑/ACCESSWIRE/2023年1月9日/Morphosys AG(法蘭克福證券交易所市場代碼:MOR;納斯達克:MOR)今天宣佈,正在進行的3期MANIFEST-2研究的主要數據預計將於2024年初上市。MANIFEST-2研究是一項全球性、隨機、雙盲臨牀試驗,探索貝伐他汀抑制劑貝拉貝利與魯索利替尼聯合作為治療骨髓纖維化患者的一線藥物。該公司此前曾表示,這些數據預計將在2024年上半年發佈。MorPhoSys公司首席執行官Jean-Paul Kress醫學博士將在2023年1月11日(星期三)下午5點15分舉行的第41屆J.P.摩根醫療會議上提供關於Pelabresb計劃和該公司其他腫瘤學計劃的進一步更新。加州舊金山的太平洋標準時間。

"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説:“對於骨髓纖維化患者,目前一線治療的反應深度和持久性有限。最新的第二階段數據表明,Pelabresb可能具有提高護理標準的潛力,重申了我們對第三階段MANIFEST-2研究的信心。”我們期待着在摩根大通醫療保健會議期間提供關於Pelabresb計劃和我們的其他臨牀計劃的進一步更新。“

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.

要觀看和收聽演示文稿的網絡直播,請訪問MorPhoSys的網站:。演示文稿和網絡直播的重播也將在該公司的網站上觀看。

About MorphoSys

關於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,我們的動力來自我們的使命:為癌症患者提供更多的生命。作為一家全球商業階段的生物製藥公司,我們使用突破性的科學和技術來發現、開發和向患者提供創新的抗癌藥物。Morphosys總部設在德國的普蘭格,其美國業務的總部設在馬薩諸塞州的波士頓。要了解更多信息,請訪問我們,並在Twitter和LinkedIn上關注我們。

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.

關於佩拉布利布
Pelabresb(CPI-0610)是一種研究中的選擇性小分子,旨在通過抑制溴結構域和末端外結構域(BET)蛋白的功能來減少癌症中異常表達的基因的表達,從而促進抗腫瘤活性。Pelabreb作為治療骨髓纖維化的藥物正在接受研究,尚未得到任何監管機構的評估或批准。

About Myelofibrosis

關於骨髓纖維化

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.

骨髓纖維化是一種骨髓癌,會在骨髓中造成廣泛的疤痕,擾亂身體正常生產健康血細胞。其結果是紅細胞和血小板的減少,前者會導致虛弱和疲勞,後者會增加由於凝血不足而出血的風險。骨髓纖維化通常會導致脾腫大,嚴重影響患者的生活質量。它最常在50歲以上的人羣中被診斷出來,可以自行發生(稱為原發性骨髓纖維化),也可以因為其他骨髓疾病而發生。

About MANIFEST-2

關於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)是一項全球性、雙盲、隨機的3期臨牀試驗,使用培拉貝利聯合魯索利替尼與安慰劑加魯索利替尼治療JAK抑制劑-NAÏVE伴骨髓纖維化患者。研究的主要終點是在24周時脾體積(SVR35)比基線減少35%或更多。這項研究的一個關鍵次要終點是在24周時總症狀評分(TSS50)比基線改善50%或更多。Morphy Sys公司旗下的星座製藥公司是MANIFEST-2試驗的贊助商。

Forward Looking Statements

前瞻性陳述

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.

本新聞稿包含有關MorPhoSys集團公司的某些前瞻性陳述。本新聞稿中包含的前瞻性陳述代表MorPhoSys截至本新聞稿發佈之日的判斷,涉及已知和未知的風險和不確定因素,可能會導致MorPhoSys的實際結果、財務狀況和流動性、業績或成就或行業結果與此類前瞻性陳述明示或暗示的任何歷史或未來結果、財務狀況和流動性、業績或成就大不相同。此外,即使MorPhoSys的業績、業績、財務狀況和流動性,以及它所經營的行業的發展與這些前瞻性陳述一致,它們也可能不能預測未來的結果或發展。可能導致差異的因素包括:MorPhoSys的預期可能是不正確的,與競爭開發、臨牀試驗和產品開發活動以及監管批准要求相關的內在不確定性,MorPhoSys對與第三方合作的依賴,對其開發計劃的商業潛力的估計,以及MorPhoSys提交給美國證券交易委員會的20-F表格年度報告和其他文件中包括的風險因素中指出的其他風險。鑑於這些不確定性,建議讀者不要過度依賴此類前瞻性陳述。這些前瞻性陳述僅代表截至本文件發表之日的情況。Morphosys明確表示沒有義務更新本文件中的任何此類前瞻性陳述,以反映其對此的任何預期變化或事件的任何變化, 任何此類陳述所依據的條件或情況,或可能影響實際結果與前瞻性陳述中陳述的結果不同的可能性,除非法律或法規特別要求。

For more information, please contact:

如需更多信息,請聯繫:

MorphoSys

睡眠症

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

媒體聯繫人:
託馬斯·比吉
美國副總統
電話:+49(0)89/89927 26079
郵箱:thomas.biegi@morosys.com

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

投資者聯繫方式:
朱莉婭·紐格鮑爾博士
投資者關係主管
電話:+49(0)89/899 27179
郵箱:julia.neugebauer@morosys.com

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

埃蒙·諾蘭
董事
電話:+1617-548-9271
郵箱:eamonn.nolan@morosys.com

SOURCE: MorphoSys AG

資料來源:Morphosys公司


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