MILAN--(BUSINESS WIRE)--Enthera Pharmaceuticals (“Enthera”), a clinical-stage biotech company developing first-in-class antibody therapeutics targeting the Insulin Growth Factor Binding Protein (IGFBP) family for selected inflammatory diseases, today announced the appointment of Lisa M. Olson, Ph.D., as the company’s Chief Executive Officer.

米兰--（商业新闻短讯）--临床阶段生物技术公司Enthera Pharmaceuticals（“Enthera”）今天宣布任命Lisa M.Olson博士为公司首席执行官，该公司开发针对胰岛素生长因子结合蛋白（IGFBP）家族的一流抗体治疗剂，用于治疗某些炎症性疾病。

Dr. Olson joins Enthera’s management team with over two decades of leadership experience in the biopharmaceutical industry including a successful career at AbbVie. She previously served as a member of Enthera’s Board of Directors and Chair of the Scientific Advisory Board..

Olson博士加入了Enthera的管理团队，在生物制药行业拥有20多年的领导经验，包括在AbbVie的成功职业生涯。她曾担任恩特拉董事会成员和科学顾问委员会主席。。

Enthera also announced completion of Ent001’s Phase 1a single-ascending dose trial in healthy volunteers, establishing a positive safety and tolerability profile and enabling the start of the Phase 1b multiple ascending dose trial in ulcerative colitis (UC) patients. UC is a chronic gastrointestinal disease, and while treatment options using immune suppressors are efficacious, they still fail to provide a durable and long-term response for many patients with moderately to severely active disease.

Enthera还宣布，在健康志愿者中完成了Ent001的1a期单次递增剂量试验，建立了积极的安全性和耐受性概况，并启动了溃疡性结肠炎（UC）患者的1b期多次递增剂量试验。UC是一种慢性胃肠道疾病，虽然使用免疫抑制剂的治疗选择是有效的，但它们仍然无法为许多中度至重度活动性疾病患者提供持久和长期的反应。

Ent001 is a monoclonal antibody targeting the IGFBP3/TMEM219 pathway, which plays a critical role in gut mucosal integrity and is dysregulated in patients with inflammatory bowel diseases (IBD), including UC..

Ent001是靶向IGFBP3/TMEM219途径的单克隆抗体，其在肠粘膜完整性中起关键作用，并且在包括UC在内的炎症性肠病（IBD）患者中失调。。

“We are entering the new year with positive momentum in Enthera’s corporate and clinical evolution with Lisa’s appointment as CEO and important progress with Ent001. The Enthera team will benefit from Lisa’s scientific and R&D expertise and leadership experience cultivated across the pharmaceutical and biotechnology industries.

“随着丽莎被任命为首席执行官以及Ent001取得的重要进展，我们迎来了新的一年，Enthera的公司和临床发展势头良好。Enthera团队将受益于Lisa在制药和生物技术行业培养的科学和研发专业知识以及领导经验。

We are thrilled to have her join as CEO,” said Silvano Spinelli, Chairman of the Enthera Board of Directors..

恩特拉董事会主席西尔瓦诺·斯皮内利（SilvanoSpinelli）表示：“我们很高兴她能成为首席执行官。”。。

“I look forward to working with the Enthera team to further drive Ent001’s clinical development trajectory. We have defined an exciting opportunity with Ent001 for the long-term treatment of ulcerative colitis, a disease that continues to negatively impact the lives of many patients,” added Dr. Lisa M.

“我期待着与Enthera团队合作，进一步推动Ent001的临床发展轨迹。我们已经为长期治疗溃疡性结肠炎定义了一个令人兴奋的机会，这种疾病继续对许多患者的生活产生负面影响，”Lisa M博士补充道。

Olson, CEO of Enthera. “My goal is to ensure we deliver on the potential of Ent001 in the clinic and to achieve our ambitious corporate objectives for 2024.”.

奥尔森（Olson），恩特拉（Enthera）首席执行官。“我的目标是确保我们在诊所发挥Ent001的潜力，并实现2024年我们雄心勃勃的公司目标。”。

Ent001 Clinical Development Updates

Ent001临床开发更新

Enthera completed its single ascending dose (SAD) Phase 1a trial evaluating Ent001 in healthy volunteers, thereby laying the groundwork for evaluation in patients with IBD and other indications, including type 1 diabetes (T1D), where the IGFBP3/TMEM219 pathway also plays a key pathogenetic role. The Phase 1a trial was conducted in the Netherlands and involved 30 healthy volunteers who received single ascending doses of Ent001 or placebo administered by intravenous infusion.

Enthera完成了在健康志愿者中评估Ent001的单次递增剂量（SAD）1a期试验，从而为IBD和其他适应症（包括1型糖尿病（T1D））患者的评估奠定了基础，其中IGFBP3/TMEM219途径也起着关键的致病作用。1a期试验在荷兰进行，涉及30名健康志愿者，他们接受单次递增剂量的Ent001或安慰剂静脉输注。

The trial results established a very positive safety and tolerability profile for Ent001 without any observations of drug-related clinically relevant adverse reactions up to the highest dose tested (10mg/kg). The pharmacokinetics (PK) were linear, and the exposures reached in this study fully cover the concentrations that are predicted to be effective in patients, based on the maximum effective dose in animal disease models of UC..

试验结果为Ent001建立了非常积极的安全性和耐受性概况，没有观察到最高剂量（10mg/kg）的药物相关临床相关不良反应。药代动力学（PK）是线性的，根据UC动物疾病模型中的最大有效剂量，本研究中达到的暴露量完全覆盖了预计对患者有效的浓度。。

Based on this, Enthera has initiated a multiple ascending dose (MAD) Phase 1b clinical trial in patients with moderately to severely active UC.

基于此，Enthera启动了一项针对中度至重度活动性UC患者的多剂量递增（MAD）1b期临床试验。

The Phase 1b multicenter, randomized, double-blind, placebo-controlled trial will evaluate the safety, tolerability, immunogenicity and PK of multiple ascending doses of Ent001 in up to 40 patients with moderately to severely active UC. The trial will also analyze pharmacodynamic responses by measuring peripheral and colon tissue biomarkers of IGFBP3/TMEM219 pathway inhibition to demonstrate proof of mechanism in patients with active colitis.

1b期多中心，随机，双盲，安慰剂对照试验将评估40例中度至重度活动性UC患者多次递增剂量Ent001的安全性，耐受性，免疫原性和PK。该试验还将通过测量IGFBP3/TMEM219途径抑制的外周和结肠组织生物标志物来分析药效学反应，以证明活动性结肠炎患者的机制证据。

Patients will be dosed up to week 12 to collect exploratory efficacy data and evidence of the compelling mucosal healing effect observed in preclinical models of colitis..

患者将在第12周服用，以收集探索性疗效数据和在结肠炎临床前模型中观察到的引人注目的粘膜愈合效果的证据。。

About Dr. Lisa M. Olson, CEO of Enthera

关于Enthera首席执行官Lisa M.Olson博士

Prior to joining Enthera, Dr. Olson most recently served as the Chief Scientific Officer of Magenta Therapeutics where she was responsible for the strategic direction and execution of the company’s research and development efforts. Before this, Dr. Olson held various leadership positions at AbbVie and Abbott Laboratories for fifteen years, culminating in her role as Vice President Immunology Discovery and Site Head of the AbbVie Bioresearch Center.

在加入Enthera之前，Olson博士最近担任Magenta Therapeutics的首席科学官，负责公司研发工作的战略方向和执行。在此之前，奥尔森博士在AbbVie和Abbott实验室担任了15年的各种领导职位，最终担任了免疫学发现副总裁和AbbVie生物研究中心的现场负责人。

During her time at AbbVie she successfully advanced 15 molecules into clinical development including Rinvoq™ (upadacitinib) for the treatment of several conditions, including UC. Dr. Olson joined Abbott following her time as a Research Fellow in Inflammation and Immunology at Pfizer, Inc. Dr. Olson started her career as an Assistant Professor at Washington University School of Medicine following a post-doctoral cardiovascular fellowship at the University of Chicago.

在AbbVie任职期间，她成功地将15种分子推进了临床开发，包括Rinvoq™ （upadacitinib）用于治疗多种疾病，包括UC。奥尔森博士在辉瑞公司（Pfizer，Inc.）担任炎症和免疫学研究员后加入雅培。奥尔森博士在芝加哥大学（University of Chicago）获得博士后心血管研究金后，开始了她在华盛顿大学医学院（Washington University School of Medicine）担任助理教授的职业生涯。

She holds a Ph.D. from the University of Illinois at Urbana-Champaign and a B.S. from Iowa State University..

她拥有伊利诺伊大学厄本那-香槟分校的博士学位和爱荷华州立大学的学士学位。。

About Enthera Pharmaceuticals

关于Enthera Pharmaceuticals

Enthera Srl is a clinical-stage biotech company developing first-in-class antibody therapeutics to transform the treatment paradigm in inflammatory bowel diseases (IBD) and type 1 diabetes (T1D) by re-establishing stem cell capabilities. Enthera’s pioneering approach capitalizes on the key discovery of the IGFBP3/TMEM219 pathway, which is involved in stem cell and beta cell apoptosis in the gut and pancreas, respectively.

Enthera Srl是一家临床阶段的生物技术公司，开发一流的抗体疗法，通过重建干细胞能力来改变炎症性肠病（IBD）和1型糖尿病（T1D）的治疗模式。Enthera的开创性方法利用了IGFBP3/TMEM219途径的关键发现，该途径分别参与肠道和胰腺中的干细胞和β细胞凋亡。

Enthera’s lead program, Ent001, which is currently in Phase 1 clinical development, has the potential to restore the original intestinal mucosal structure in IBD and the endogenous pancreatic stem cell compartment in T1D, resulting in the restoration of organ function..

Enthera的领先项目Ent001目前正处于1期临床开发阶段，有可能恢复IBD的原始肠粘膜结构和T1D的内源性胰腺干细胞区室，从而恢复器官功能。。

Enthera is a private company headquartered in Milan, Italy and founded in 2016 by Prof. Paolo Fiorina and Dr. Francesca D’Addio with BiovelocITA, Italy’s first biotech accelerator. Enthera’s discovery engine and assets are protected by a broad portfolio of patents. The company is backed by Sofinnova Partners, AbbVie, JDRF T1D Fund, Roche Venture Fund, and several private investors..

Enthera是一家私营公司，总部位于意大利米兰，由保罗·菲奥里纳教授和弗朗西斯卡·达迪奥博士于2016年与意大利第一家生物技术加速器BiovelocITA共同创立。Enthera的发现引擎和资产受到广泛的专利保护。该公司得到了Sofinnova Partners、AbbVie、JDRF T1D Fund、Roche Venture Fund和一些私人投资者的支持。。

For further information: www.entherapharmaceuticals.com

更多信息：www.entherapaceuticals.com