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Entera Bio Appoints Dr. Rachel B Wagman as Key Clinical Advisor and Scientific Advisory Board Member

Entera Bio Appoints Dr. Rachel B Wagman as Key Clinical Advisor and Scientific Advisory Board Member

Entera Bio 任命 Rachel B Wagman 博士为主要临床顾问和科学顾问委员会成员
GlobeNewswire ·  05/15 08:00

JERUSALEM, May 15, 2024 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ: ENTX), ("Entera" or the "Company"), a leader in the development of orally delivered peptides and small therapeutic proteins, today announced the appointment of Rachel B Wagman, MD, FACE, FACP, as Key Clinical Advisor and Member of its Scientific Advisory Board. Dr. Wagman brings more than 20 years of metabolic bone disease and women's health research and drug development experience to Entera. She has successfully advanced the development of five molecules, including the osteoporosis products teriparatide (Forteo), denosumab (Prolia) and romosozumab (Evenity) through clinical development, registration, and lifecycle management.

耶路撒冷,2024年5月15日(环球通讯社)——口服肽和小型治疗蛋白开发领域的领导者Entera Bio Ltd.(纳斯达克股票代码:ENTX)(“Entera” 或 “公司”)今天宣布任命FACP医学博士雷切尔·瓦格曼为主要临床顾问兼科学顾问委员会成员。瓦格曼博士为Entera带来了20多年的代谢性骨病和女性健康研究和药物开发经验。她通过临床开发、注册和生命周期管理,成功推进了五种分子的开发,包括骨质疏松症产品特立帕肽(Forteo)、denosumab(Prolia)和romosozumab(Evenity)。

"Rachel's patient-focused approach and track record advancing multiple blockbuster treatments through clinical development to registration, coupled with her therapeutic specializations in the specific areas Entera is focused on, is a significant advantage in the continued build out of our oral peptide pipeline. We are extremely excited to welcome Rachel to Entera," said Miranda Toledano, CEO of Entera.

“Rachel以患者为中心的方法和从临床开发到注册推进多种重磅疗法的往绩,再加上她在Entera专注的特定领域的治疗专长,是我们持续扩大口服肽产品线的显著优势。我们非常高兴欢迎瑞秋加入Entera。” Entera首席执行官米兰达·托莱达诺说。

"I have been committed to bring innovative medicines to patients whose needs are not met with current treatment options. In osteoporosis, complacency is the largest barrier to help patients reduce the risk for fracture. Identification of new options to address their needs remains an important enterprise," said Dr. Wagman. "Entera's unique oral peptide delivery technology platform offers the prospect to address several chronic metabolic disorders. I am delighted to have the opportunity to work with the talented Entera team and support their work, which has the potential to significantly improve patient care."

“我一直致力于为当前治疗方案无法满足需求的患者提供创新药物。在骨质疏松症中,自满情绪是帮助患者降低骨折风险的最大障碍。寻找满足他们需求的新选择仍然是一项重要的任务,” 瓦格曼博士说。“Entera独特的口服肽输送技术平台为解决多种慢性代谢疾病提供了前景。我很高兴有机会与才华横溢的Entera团队合作并支持他们的工作,这有可能显著改善患者护理。”

Dr. Wagman's clinical leadership experiences include progressive roles at Eli Lilly, Amgen, and Myovant Sciences, where, as Senior Vice President, Clinical Development, she integrated Myovant's development portfolio into the newly-established Sumitomo Pharma America. She completed her BA at the University of Pennsylvania, MD at Jefferson Medical College, Internal Medicine residency at Thomas Jefferson University Hospital, and postdoctoral fellowship in Endocrinology, Gerontology, and Metabolism at Stanford University School of Medicine. She is a Fellow of both the American College of Endocrinology and the American College of Physicians and holds dual board certifications in Internal Medicine and Endocrinology, Diabetes, and Metabolism.

瓦格曼博士的临床领导经历包括在礼来、安进和Myovant Sciences担任的渐进职务,作为临床开发高级副总裁,她将Myovant的开发组合整合到新成立的美国住友制药公司。她在宾夕法尼亚大学完成了学士学位,在杰斐逊医学院完成了医学博士,在托马斯·杰斐逊大学医院完成了内科住院医师学位,在斯坦福大学医学院完成了内分泌、老年学和新陈代谢博士后奖学金。她是美国内分泌学会和美国内科医师学会的会员,并拥有内科和内分泌学、糖尿病和新陈代谢方面的双委员会认证。

About Entera Bio

关于 Entera Bio

Entera is a clinical stage company focused on developing oral peptide or protein replacement therapies for significant unmet medical needs where an oral tablet form holds the potential to transform the standard of care. The Company leverages on a disruptive and proprietary technology platform (N-Tab) and its pipeline includes five differentiated, first-in-class oral peptide programs, expected to enter the clinic (Phase 1 to Phase 3) by 2025. The Company's most advanced product candidate, EB613 (oral PTH(1-34)), is being developed as the first oral, osteoanabolic (bone building) once-daily tablet treatment for post-menopausal women with low BMD and high-risk osteoporosis, with no prior fracture. A placebo controlled, dose ranging Phase 2 study of EB613 tablets (n= 161) met primary (PD/bone turnover biomarker) and secondary endpoints (BMD). Entera is preparing to initiate a Phase 3 registrational study for EB613 pursuant to the FDA's qualification of a quantitative BMD endpoint which is expected to occur by January 2025. The EB612 program is being developed as the first oral PTH(1-34) tablet peptide replacement therapy for hypoparathyroidism. Entera is also developing the first oral oxyntomodulin, a dual targeted GLP1/glucagon peptide, in tablet form for the treatment of obesity; and first oral GLP-2 peptide tablet as an injection-free alternative for patients suffering from rare malabsorption conditions such as short bowel syndrome in collaboration with OPKO Health. For more information on Entera Bio, visit or follow us on LinkedIn, Twitter, Facebook, Instagram.

Entera是一家临床阶段的公司,专注于开发口服肽或蛋白质替代疗法,以满足尚未满足的重大医疗需求,在这些需求中,口服片剂有可能改变护理标准。该公司利用颠覆性的专有技术平台(N-Tab),其产品线包括五个差异化的、同类首创的口服肽项目,预计将在2025年进入临床(第一阶段至第三阶段)。该公司最先进的候选产品 EB613(口服 PTH(1-34))正在开发中,它是首款口服、整骨代谢(造骨)片剂治疗药物,适用于骨密度低和高风险骨质疏松症的绝经后女性,此前没有骨折。一项针对 EB613 片剂(n= 161)的安慰剂对照、剂量范围的 2 期研究符合主要终点(PD/骨周转生物标志物)和次要终点(BMD)。根据美国食品药品管理局对骨髓病定量终点的认证,Entera正准备启动 EB613 的3期注册研究,该研究预计将于2025年1月进行。EB612 计划是作为第一种口服 PTH(1-34)片剂肽替代疗法开发的,用于甲状旁腺功能减退症。Entera 还在开发第一款口服 oxyntomodulin,一种双靶向 GLP1/Glucagon 肽,以片剂形式治疗肥胖;并与 OPKO Health 合作开发了第一款口服 GLP-2 肽片剂,作为针对患有罕见吸收不良疾病(例如短肠综合征)的患者的免注射替代品。有关Entera Bio的更多信息,请在领英、推特、脸书、Instagram上访问或关注我们。

Cautionary Statement Regarding Forward Looking Statements

关于前瞻性陈述的警示声明

Various statements in this press release are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. All statements (other than statements of historical facts) in this press release regarding our prospects, plans, financial position, business strategy and expected financial and operational results may constitute forward-looking statements. Words such as, but not limited to, "anticipate," "believe," "can," "could," "expect," "estimate," "design," "goal," "intend," "may," "might," "objective," "plan," "predict," "project," "target," "likely," "should," "will," and "would," or the negative of these terms and similar expressions or words, identify forward-looking statements. Forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties. Forward-looking statements should not be read as a guarantee of future performance or results and may not be accurate indications of when such performance or results will be achieved.

本新闻稿中的各种声明均为1995年《私人证券诉讼改革法》所指的 “前瞻性陈述”。本新闻稿中有关我们的前景、计划、财务状况、业务战略以及预期财务和经营业绩的所有陈述(历史事实陈述除外)均可能构成前瞻性陈述。但不限于 “预测”、“相信”、“可以”、“可以”、“期望”、“估计”、“设计”、“目标”、“打算”、“可能”、“目标”、“计划”、“预测”、“项目”、“目标”、“可能”、“可能”、“应该”、“将” 和 “会” 等词语,或其中的否定词术语和类似的表达方式或词语,标识前瞻性陈述。前瞻性陈述基于当前的预期,涉及风险、情况变化、假设和不确定性。前瞻性陈述不应被视为对未来业绩或业绩的保证,也可能无法准确表明何时实现此类业绩或成果。

Important factors that could cause actual results to differ materially from those reflected in Entera's forward-looking statements include, among others: changes in the interpretation of clinical data; results of our clinical trials; the FDA's interpretation and review of our results from and analysis of our clinical trials; unexpected changes in our ongoing and planned preclinical development and clinical trials, the timing of and our ability to make regulatory filings and obtain and maintain regulatory approvals for our product candidates; the potential disruption and delay of manufacturing supply chains; loss of available workforce resources, either by Entera or its collaboration and laboratory partners; impacts to research and development or clinical activities that Entera may be contractually obligated to provide; overall regulatory timelines; the size and growth of the potential markets for our product candidates; the scope, progress and costs of developing Entera's product candidates; Entera's reliance on third parties to conduct its clinical trials; Entera's expectations regarding licensing, business transactions and strategic collaborations; Entera's operation as a development stage company with limited operating history; Entera's ability to continue as a going concern absent access to sources of liquidity; Entera's ability to obtain and maintain regulatory approval for any of its product candidates; Entera's ability to comply with Nasdaq's minimum listing standards and other matters related to compliance with the requirements of being a public company in the United States; Entera's intellectual property position and its ability to protect its intellectual property; and other factors that are described in the "Cautionary Statements Regarding Forward-Looking Statements," "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Entera's most recent Annual Report on Form 10-K filed with the SEC, as well as the company's subsequently filed Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. There can be no assurance that the actual results or developments anticipated by Entera will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Entera. Therefore, no assurance can be given that the outcomes stated or implied in such forward-looking statements and estimates will be achieved. Entera cautions investors not to rely on the forward-looking statements Entera makes in this press release. The information in this press release is provided only as of the date of this press release, and Entera undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, except to the extent required by law.

可能导致实际结果与Entera前瞻性陈述中反映的结果存在重大差异的重要因素包括:临床数据解释的变化;我们的临床试验结果;美国食品药品管理局对我们临床试验结果的解释和审查;我们正在和计划中的临床前开发和临床试验的意外变化、监管申报以及获得和维持候选产品的监管批准的时间和能力;潜在的制造供应链的中断和延迟;Entera或其合作和实验室合作伙伴的可用劳动力资源的流失;对Entera可能有合同义务提供的研发或临床活动的影响;总体监管时间表;候选产品潜在市场的规模和增长;开发Entera候选产品的范围、进展和成本;Entera对第三方进行临床试验的依赖;Entera对第三方进行临床试验的预期许可,商业交易和战略合作;Entera作为一家处于发展阶段的公司的运营,运营历史有限;Entera在没有流动性来源的情况下继续作为持续经营企业的能力;Entera获得和维持监管部门对其任何候选产品的批准的能力;Entera遵守纳斯达克最低上市标准以及与遵守美国上市公司要求相关的其他事项的能力;Entera的知识产权状况及其能力保护其智力财产;以及Entera最近向美国证券交易委员会提交的10-K表年度报告以及该公司随后提交的10-Q表季度报告和8-K表最新报告中 “关于前瞻性陈述的警示性陈述”、“风险因素” 和 “管理层对财务状况和经营业绩的讨论和分析” 部分中描述的其他因素。无法保证Entera预期的实际结果或发展能够实现,即使已基本实现,也无法保证它们会对Entera产生预期的后果或影响。因此,无法保证此类前瞻性陈述和估计中陈述或暗示的结果将实现。Entera提醒投资者不要依赖Entera在本新闻稿中发表的前瞻性陈述。本新闻稿中的信息仅在本新闻稿发布之日提供,除非法律要求,否则Entera没有义务公开更新或修改任何前瞻性陈述,无论是由于新信息、未来事件还是其他原因。

CONTACT: Contact:  Entera Bio: Ms. Miranda Toledano Chief Executive Officer Entera Bio Email: miranda@enterabio.com
联系人:联系人:Entera Bio:Miranda Toledano 女士首席执行官 Entera Bio 电子邮件:miranda@enterabio.com

声明:本内容仅用作提供资讯及教育之目的,不构成对任何特定投资或投资策略的推荐或认可。 更多信息
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