Teduglutide Recombinant

MIAMI and JERUSALEM, July 08, 2025 (GLOBE NEWSWIRE) -- OPKO Health, Inc. (NASDAQ: OPK) (“OPKO”) and Entera Bio Ltd. (NASDAQ: ENTX) (“Entera”) today announced that their abstract “First-in-Class Oral GLP-2 Analog for Treatment of Short Bowel Syndrome” has been selected for a poster presentation at the 47th European Society for Clinical Nutrition & Metabolism (“ESPEN”) Congress, taking place September 13–16, 2025, in Prague, Czech Republic. Abstract Title: First-in-Class Oral GLP-2 Analog for Treatment of Short Bowel Syndrome Poster Viewing Date & Time: September 13, 2025, 3:30 - 4:00 p.m. local time & Welcome Reception Poster Topic: Poster Session 1 - Liver and gastrointestinal tract Location of Display: Forum Hall Foyer 3 The oral GLP-2 tablet program combines a proprietary long acting GLP-2 agonist developed by OPKO with Entera’s proprietary N-Tab™ technology for patients suffering from short bowel syndrome and additional disorders involving gastrointestinal mucosal inflammation and nutrient malabsorption. Currently, the only approved GLP-2 agonist, which is marketed under the brand GATTEX® (teduglutide), requires daily subcutaneous injections. “Given the heterogeneity of patients with SBS and challenging compliance rates attributed to injectable GLP-2 therapy, we believe a daily tablet format may enable more personalized care of this peptide and individualize titration,” said Miranda Toledano, Entera Chief Executive Officer. About Short Bowel Syndrome Short bowel syndrome (SBS) is a rare and potentially life-threatening malabsorptive condition caused by a significant loss of functional bowel mass (secondary to congenital defects or disease-associated loss of absorption) or physical bowel mass (secondary to extensive intestinal resection). Approximately 30,000 patients across the US and EU are living with SBS, and current annual sales of GATTEX® (teduglutide), the only approved therapy for SBS, total roughly $800 million. SBS patients have a reduced ability to absorb nutrients and fluids and are at risk of malnutrition, unintended weight loss and additional symptoms due to the loss of essential vitamins and minerals1. SBS is the most common cause of chronic intestinal failure, accounting for approximately 75% of chronic intestinal failure cases in adults and 50% of such events in children.2 About Entera Bio Entera is a clinical stage company focused on developing oral peptide and 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 a disruptive and proprietary technology platform (N-Tab™) and its pipeline of first-in-class oral peptide programs targeting PTH(1-34), GLP-1 and GLP-2. 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. 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. 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 the 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 www.enterabio.com or follow us on LinkedIn, Twitter, Facebook, Instagram. About OPKO Health OPKO Health is a multinational biopharmaceutical and diagnostics company that seeks to establish industry-leading positions in large, rapidly growing markets by leveraging its discovery, development and commercialization expertise, and its novel and proprietary technologies. For more information, visit www.opko.com. Cautionary Statement Regarding Forward Looking Statements Various statements in this presentation 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 presentation 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. Important factors that could cause actual results to differ materially from those reflected in Entera’s and OPKO’s forward-looking statements include, among others: results of our clinical trials; the anticipated benefits of an oral tablet for the treatment of SBS; 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 each of Entera’s and OPKO’s most recent Annual Reports on Form 10-K filed with the SEC, as well as the companies’ respective 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 and OPKO will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Entera or OPKO, as applicable. Therefore, no assurance can be given that the outcomes stated or implied in such forward-looking statements and estimates will be achieved. Entera and OPKO caution investors not to rely on the forward-looking statements made in this press release. The information in this press release is provided only as of the date of this press release, and neither Entera nor OPKO undertakes any 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. 1 https://rarediseases.org/rare-diseases/short-bowel-syndrome/ 2 Zhu C, Li Y. An updated overview of glucagon-like peptide-2 analog trophic therapy for short bowel syndrome in adults. J Int Med Res. 2022 Mar;50(3):3000605221086145. doi: 10.1177/03000605221086145. PMID: 35343263; PMCID: PMC8966062. Released July 8, 2025

6月2日（当地时间），丹麦制药公司Zealand Pharma A/S宣布向EMA（欧洲药品管理局）递交长效GLP-2(胰高血糖素样肽-2）类似物Glepaglutide上市许可申请（MAA），适应症：治疗短肠综合征（SBS )成人患者。新闻稿称，EMA递交MAA依据来自Glepaglutide每周二次治疗SBS的关键3期临床研究（EASE-1）和两项进行中长期扩展研究（EASE-2和EASE-3）以及机制研究（EASE-4）的支持。EASE-1研究（NCT03690206） 是一项随机、双盲3期试验，共招募了106例每周至少3天依赖肠外支持（PS）肠衰竭SBS患者。患者随机接受10 mg Glepaglutide治疗（每周一次或两次）或安慰剂治疗。主要终点24周时每周肠外支持量相对于基线的绝对变化。研究结果显示，24周时每周两次Glepaglutide每周PS总体积减少5.13L/周，而安慰剂组每周减少2.85L/周（p=0.0039）。当每周给药一次时，Glepaglutide每周PS降低3.13L/周，较安慰剂未达到统计学意义。共有9例接受Glepaglutide治疗患者完全停用PS（实现肠内自主），而安慰剂组患者无法停止PS。对于每周两次接受Glepaglutide治疗患者，14%患者（n=5）实现肠自主。106例患者中102例完成EASE-1研究，其中96例继续为期两年的长期安全性和有效性扩展试验EASE-2研究。EASE-2研究（NCT03905707）是一项随机、双盲试验，其中SBS患者继续EASE-1治疗，Glepaglutide10 mg（每周一次或两次）。EASE-1研究安慰患者被重新随机分配接受10 mg Glepaglutide治疗（每周一次或每周两次）。治疗至少6个月后中期分析，关键疗效终点对Glepaglutide临床反应总体上保持不变或显示持续改善，包括更多两种剂量的停止PS患者。完成EASE-2研究患者有资格参加EASE-3 （NCT04881825），评估使用自动注射器每周给药一次Glepaglutide。首个57例从EASE-2研究转入EASE-3研究患者期中分析表明，PS减少保持不变。EASE-4研究（NCT04991311）是一项3b期试验，旨在评估Glepaglutide对肠液和能量摄取的机制影响，试验提供Glepaglutide在改善肠道吸收方面的药效学作用的证据。Glepaglutide为一款潜在治疗SBS的长效GLP-2类似物液体制剂，并将配备可皮下注射的自动给药装置，旨在降低或消除SBS患者的肠外营养支持，FDA曾授予孤儿药资格。2024年12月，其SBS的NDA被FDA出具完整回复函（CRL），FDA要求增加临床试验提供更多有效性和安全性证据。新闻稿中，Zealand Pharma A/S表示将于2025年下半年启动3期临床（EASE-5）以支持FDA的审批。2024年2月，日本武田制药注射用替度格鲁肽（Teduglutide）正式获得中国国家药品监督管理局（NMPA）批准（商品名：瑞唯抒/Revestive），适用于治疗短肠综合征（Short bowel syndrome，简称SBS）成人和1岁及以上儿童患者。此外，VectivBio和杭州泰格医药在2021年向CDE递交了GLP-2R激动剂注射用阿帕拉格鲁肽（Apraglutide）治疗SBS的IND申请（受理号：JXHL2100112），但未见开展临床试验信息。金赛生物和重庆派金生物在国内实施了3项针对SBS的临床试验，对应的产品分别为生长激素和重组替度格鲁肽（日本武田替度格鲁肽生物类似药）。识别微信二维码，可添加药时空小编请注明：姓名+研究方向！