The aim of this single-centre prospective randomized-controlled clinical trial is to assess whether patients adhere to prescribed weight bearing limits after surgical orthopaedic or traumatological interventions more accurately after instruction using a biofeedback method than using the standard method.

开始日期2025-03-01

申办/合作机构

Universitätsspital Basel

NCT06667999 / Not yet recruiting临床4期IIT

The Intensive Care Platform Trial (INCEPT)

Among critically ill patients, many die, and many of the survivors and their family members struggle for years with reduced quality of life. Critically ill patients are treated in intensive care units (ICUs). Here, they receive life support, e.g., mechanical ventilation and advanced support of the circulation (heart and blood vessels) and kidneys. In addition, ICU patients receive many other treatments. It is, however, uncertain if all the treatments provide value for the patients. The desirable effects of many treatments are uncertain, and some may be wasteful or even harmful.
Clinical trials are necessary to validly assess the desirable and undesirable effects of different treatments. However, conventional clinical trials have limitations:
* They typically only assess a single question related to a single comparison of treatments at a time.
* They are often not very flexible, including with regards to the number of participants needed, and this increases the risk that a trial will end up as inconclusive.
* There is no or limited re-use or sharing of infrastructure across trials, leading to duplicate work and resource use.
* Trial participants do usually not benefit from the obtained knowledge before the trial concludes.
* Involvement of patients, family members, and other stakeholders is typically limited, which may decrease the relevance of the questions addressed.
With the Intensive Care Platform Trial (INCEPT), we aim to tackle these challenges by establishing a flexible platform trial that continuously learns from the obtained results. The platform trial may run forever with simultaneous and continuous assessment of many treatments. INCEPT will continuously learn from the accrued data and use these to improve the treatment of both participating and future patients. With INCEPT, we are also building a framework for thorough and extensive involvement of key stakeholders, including patients and family members. INCEPT will improve the way clinical trials are done and increase the probabilities that treatments are improved. This will:
* Directly improve outcomes for ICU patients.
* Relieve a strained healthcare system by discarding inefficient or harmful treatments.
* Ensure that new treatments are beneficial or cost-effective before implementation.
* Lower the costs and burdens of assessing more treatments in the critically ill.

开始日期2025-03-01

申办/合作机构

Rigshospitalet

[+18]

NCT06576583 / Not yet recruiting临床2期IIT

Randomized, Controlled, Multi-center Phase II Clinical Trial for the Treatment of Patellofemoral Osteoarthritis With Nasal Chondrocyte-based Tissue Engineered Cartilage Implantation vs Current Standard of Care

ENCANTO is a randomized, controlled, multi-center phase II clinical trial for the treatment of patellofemoral osteoarthritis (PFOA) with an Advanced Therapy Medicinal Product (ATMP), nasal chondrocyte-based tissue engineered cartilage (N-TEC) implantation in comparison with current standard of care depending on the stage of osteoarthritis. The goal of this phase II trial is to evaluate the efficacy of N-TEC treatment in comparison to an active comparator Autologous Matrix Induced Chondrogenesis (AMIC) for early stage PFOA or patellofemoral arthroplasty (PFA) for late stage PFOA.
The N-TEC engineered cartilage graft is obtained by culturing expanded autologous nasal chondrocytes within a collagen type I/III membrane.

开始日期2025-01-01

申办/合作机构

Medical University of Vienna

[+7]

100 项与 University of Basel 相关的临床结果

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0 项与 University of Basel 相关的专利（医药）

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59,232

项与 University of Basel 相关的文献（医药）

2025-02-01·JOURNAL OF CRITICAL CARE

Advance directives in the intensive care unit: An eight-year vanguard cohort study

Article

作者: Baumann, Sira M. ; Gebhard, Caroline E ; Nebiker, Mathias ; Amacher, Simon A ; Berger, Sebastian ; Gebhard, Caroline E. ; Hunziker, Sabina ; Grzonka, Pascale ; Baumann, Sira M ; Cioccari, Luca ; Amacher, Simon A. ; Sutter, Raoul ; Erne, Yasmin

PURPOSE:

To investigate the frequency, content, and clinical translation of advance directives in intensive care units (ICUs).

MATERIAL AND METHODS:

Retrospective cohort study in a Swiss tertiary ICU, including patients with advance directives treated in ICUs ≥48 h. The primary endpoint was the violation of directives. Key secondary endpoints were the directives' prevalence and their translation into clinical practice.

RESULTS:

Of 5'851 patients treated ≥48 h in ICUs, 2.7 % had documented directives. Despite 92 % using templates, subjective or contradictory wording was found in 19 % and 12 %. Nine percent of directives were violated. Patients with directive violations had worse in-hospital outcomes (p = 0.012). At admission, 64 % of patients experiencing violations could not communicate, and directives were missing/unrecognized in 30 %. Mostly, directives were not followed regarding life-prolonging measures (6 %), ICU admission (5 %), and mechanical ventilation (3 %). Kaplan Meier statistics revealed a lower survival rate with directives recognized at admission (p = 0.04) and when treatment was withheld (p < 0.001).

CONCLUSIONS:

Advance directives are available in a minority of ICU patients and often contain subjective/contradictory wording. Physicians respected directives in 90 % of patients, with treatment adapted following their wishes. However, violation of directives may have serious consequences with unfavorable in-hospital outcomes and decreased long-term survival with treatment adaption following directives.

2025-01-01·PHYTOCHEMISTRY

Highly oxygenated antiplasmodial and non-hemolytic Δ7,9(11) stigmastane-type steroids from the twigs of Vernonia amygdalina Delile

Article

作者: Reinhardt, Jakob K ; Dzouemo, Liliane Clotilde ; Konfor, Silvie Munyap ; Reinhardt, Jakob K. ; Happi, Gervais Mouthé ; Sikam, Klev Gaïtan ; Rakhmanov, Malik ; Dietl, Andreas ; Teufel, Robin ; Wansi, Jean Duplex

Chemical investigations of a methanolic extract of the twigs of Vernonia amygdalina Delile (Asteraceae) resulted in the isolation and identification of three previously undescribed highly oxygenated Δ^7,9(11) stigmastane-type steroids namely vernonins U-W (1-3) along with six known compounds (4-9). The structural characterization of all the isolated compounds has been conducted via comprehensive 1D and 2D-NMR spectroscopy as well as HRMS. The seven steroidal derivatives 1-7 were evaluated for their antiplasmodial activity against the chloroquine-resistant strain P. falciparum Dd2 (PfDd2) and their hemolytic effect on human red blood cells (RBCs). Vernonins U (1), A (4) and stigmasterol-3-O-β-d-glucopyranoside (7) showed the highest activity with IC₅₀ values of (5.47 ± 0.01) μg/mL, (6.02 ± 0.13) μg/mL and (6.34 ± 0.80) μg/mL, respectively, against PfDd2, while vernonin W (3) showed moderate activity of (21.20 ± 0.40) μg/mL. None of the tested compounds displayed hemolytic effects on human RBCs up to 100 μg/mL indicating their safety. These results enrich the known chemistry of V. amygdalina and support its use in folk medicine for the treatment of malaria. This encourages further research towards new antiplasmodial drug candidates from this plant.

2024-12-31·Global health action

Applying the photovoice method with adolescents in mining areas in rural Mozambique: critical reflections and lessons learned

Article

作者: Macete, Eusébio ; Winkler, Mirko S ; Gross, Karin ; Munguambe, Khátia ; Cambaco, Olga ; Farnham, Andrea ; Cossa, Hermínio

There is a recognised need for innovative methods to elicit the perspective of adolescents on public health issues, particularly when addressing sensitive topics such as the impact of mining projects on their health. Participatory approaches such as "photovoice" allow for deep engagement of vulnerable and marginalised populations, including adolescents. However, few existing studies have used the photovoice method to reflect on issues related to the environment and its impact on public health. To date, no studies have been found that have used photovoice to gain insight into adolescents' perspectives in mining areas. In this paper, we discuss the application of the photovoice method to understand adolescents' perceptions about the impact of mining on their health and well-being in rural areas in Mozambique. The study was conducted in northern and central Mozambique. Photovoice was successfully integrated into eight focus group discussions with adolescent girls and boys aged 15 to 17 years. Several lessons for guiding future research were learned. First, it provided an understanding of the perceived impacts of mining on their health and well-being. Second, photovoice promoted active engagement and interest in the study by the adolescents. Finally, compared to its ability to capture perceptions of physical and environmental aspects affecting adolescents' well-being, the method was less straightforward in revealing their concerns regarding social, relational and community aspects that are less tangible. Programs can make use of photovoice to address health issues without setting adolescents' views and priorities aside, allowing them to influence health decisions on issues that are meaningful to them. Future studies should explore strategies to minimise the role of the power dynamics that affect the engagement and contribution of adolescents in advocating for necessary and meaningful changes. Additionally, it is important to investigate how health programs and policies can help to reduce the impact of existing inequalities.

164

项与 University of Basel 相关的新闻（医药）

2024-10-26

·药事纵横

阿尔茨海默病迷局：礼来市场准入受阻、罗氏终止合作

声明：因水平有限，错误不可避免，或有些信息非最及时，欢迎留言指出。本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及）;本文不构成任何投资建议。阿尔茨海默病作为一种极具挑战性的神经退行性疾病，其治疗开发一直在不断碰壁。尽管科研进展推动了对β-淀粉样蛋白、tau蛋白等病理机制的理解，但转化为有效疗法的道路却充满了波折和不确定性。随着全球老龄化的加速，这一疾病给医疗体系和家庭带来的负担日益严峻，迫切需要新的突破。然而，药物开发的每一个环节不仅是科学探索的漫长旅程，还是制药公司在面对临床试验、监管审查和市场准入等多重挑战下的平衡考验。在这一背景下，阿尔茨海默病疗法的研发逐渐成为一个充满竞争和变数的战场。科学与商业、技术与政策、希望与挫折，交织成了这场攻坚战的独特格局，背后是企业愿景与市场现实的博弈。在这场漫长的竞赛中，成功并不仅取决于科研的前沿性，更在于对战略选择的深思熟虑和对市场复杂局面的精准把控。阿尔茨海默病疗法的开发，似乎正面临着“东边日出西边雨”的局面。临门一脚，礼来Donanemab商业化英国受阻在渤健和卫材将Aduhelm撤市之后，礼来的donanemab成为了市场上最主要的阿尔茨海默病单抗疗法之一。然而donanemab在英国的商业化受到了重大挫折。虽然donanemab已经获得英国药品和保健品监管机构（MHRA）的批准，但近日英国国家卫生与临床优化研究所（NICE）再次对donanemab表示了质疑，认为其疗效有限，成本高昂，无法证明其对纳税人来说具有良好的价值。NICE罗列的理由包括相对较小的效益和高昂的成本，包括药物本身的价格、每月输注的费用以及因药物副作用引发的监测费用，因此暂时不适合在英国国家医疗服务体系（NHS）中使用。尽管美国已批准donanemab并以Kisunla的商品名销售（价格约为每年32000美元），但英国通常通过谈判降低NHS中提供的药品价格。对此，NICE认为，临床试验数据表明donanemab虽然能延缓阿尔茨海默病进展四到七个月，但其长期效益尚不明确，且其成本效益指数超出NHS通常接受的范围五至六倍。对于NICE的评估礼来在一份声明中表示，患者在β-淀粉样蛋白水平降至一定程度后可停止使用donanemab，这有助于降低输液次数和相关成本。因此礼来仍对donanemab的临床疗效和成本效益充满信心，并将继续与NICE密切合作，希望在咨询期结束后推动药物进入NHS系统。 NICE的立场是有据可循的。今年8月，NICE也曾在草案中认为渤健和卫材的阿尔茨海默病单抗疗法Leqembi（lecanemab）同样不具备成本效益。虽然Leqembi的关键临床试验证实它们能减缓阿尔茨海默病的早期进展，但专家们仍对它们对患者的实际意义及其高昂的成本和副作用展开了激烈的讨论。 NICE负责评估新药及疗法的临床和经济效益，帮助决定哪些治疗方案应纳入英国国家医疗服务体系（NHS）的覆盖范围。其目的是确保纳税人的资金被有效利用，同时患者能够获得高效且负担得起的治疗。这有些类似于美国PBM (Pharmacy Benifit Manager，药品福利管理者)的角色，但NICE并不参与利益的瓜分。NICE的评估过程主要包括两个方面：临床效益和成本效益。首先，NICE会审查新药在临床试验中的表现，评估其是否能够有效地延长患者的寿命或改善生活质量。这一过程确保药物不仅在技术上可行，还在实际使用中能带来显著的健康收益。其次，NICE还会重点分析药物的成本效益。评估的关键标准是药物的价格是否合理，通常通过衡量每个健康生命年（QALY）的成本来判断。QALY是一个综合指标，反映药物能否为患者延长高质量的生命时间。通常，NICE对 NHS资源的合理使用设定了一个上限，即药物的成本效益必须处于合理范围内，如果某种疗法的费用过高而效益有限，它可能不被推荐纳入NHS 覆盖。对于 NHS来说，NICE的正面评价通常是药物被列入常规覆盖的前提条件。因此，NICE的评估对患者能否通过NHS 获得某种药物至关重要。这种评估体系确保公共卫生资金的有效使用，同时为患者提供有益的治疗。半途而废，罗氏终止与USB的合作项目礼来的挑战出现在商业化的阶段，而有志于进入阿尔茨海默病市场的罗氏则在研发的道路上遭遇挫折。罗氏日前宣布终止与UCB共同开发阿尔茨海默病候选药物bepranemab的合作，这是罗氏今年第三次放弃阿尔茨海默病项目。早在1月，罗氏就将两项合作开发的阿尔茨海默病资产归还给了AC Immune。罗氏与UCB于2020年达成的合作原本包括1.2亿美元的预付款和高达20亿美元的潜在里程碑付款。不同于已经上市的lecanemab和donanemab，bepranemab靶向的是tau蛋白，tau蛋白同β-淀粉样蛋白一样被视为阿尔茨海默病的生物标志物。在阿尔茨海默病的诊断和研究中，tau蛋白的水平和磷酸化状态常被用作生物标志物。通过脑脊液（CSF）或血液中的tau蛋白水平，可以评估疾病的进展和严重程度。研究表明，tau蛋白的升高与认知功能的下降密切相关，且在疾病早期就可能检测到其变化。因此，tau蛋白不仅是阿尔茨海默病的关键生物标志物，也是开发新治疗方法的潜在靶点。然而bepranemab的IIa期临床试验结果却令罗氏兴致阑珊，最终决定将该药物的开发权交还给UCB。尽管罗氏在其2024年第一季度的财报中曾表示，预计bepranemab将于2027年或更晚提交监管申请，但在随后的第二季度财报中却未提及bepranemab，这已经显出了罗氏准备偃旗息鼓的迹象。罗氏在阿尔茨海默病药物开发方面可谓命运多舛。其早期的候选药物gantenerumab在2022年未能通过两项III期临床试验，导致罗氏在阿尔茨海默病领域的万丈雄心遭遇重大挫折。但面对一系列挫折，罗氏依然矢志不渝，仍在积极其他阿尔茨海默病资产，如RG6289和trontinemab（RG6102）。后者在早期临床试验中显示出对淀粉样蛋白斑块的显著清除效果。在被罗氏“抛弃”之后，UCB表示将在获得外部专家的反馈后评估bepranemab未来的发展方向。Bepranemab是一种靶向tau蛋白中重要区域的单克隆抗体，可能干扰病理性聚集tau蛋白的细胞传播。UCB相信，bepranemab的独特的作用机制存在很大的开发价值。Bepranemab结合tau蛋白的中间区而不是N端，这在干预tau传播方面可能比其他抗体更加有效。目前有多种抗tau 蛋白疗法正处于阿尔茨海默病的临床前和临床开发阶段，许多公司将tau靶向药物视为提高β淀粉样蛋白清除抗体的增强剂，也就是产生有利的协同作用，尽管USB和罗氏的协同作用已经走到了终点。虽然罗氏终止了与UCB的合作，但他们仍对tau靶向疗法开发保持了浓厚兴趣，终止与USB的合作“非战之罪也”。罗氏仍在试图针对tau 蛋白开发阿尔茨海默病疗法，包括与Sangamo Therapeutics Inc. 建立的临床前合作，两家公司于8 月签署了5000 万美元的预付款。罗氏：bepranemab已死，trontinemab当立罗氏之所以这么决绝地放弃bepranemab，在一定程度上是因为他们拥有一款嫡出的阿尔茨海默病管线资产trontinemab。 Trontinemab是由罗氏开发的一种用于阿尔茨海默病单抗药物候选物。它采用罗氏的“脑穿梭（Brainshuttle）”技术，以蛋白质之躯跨越血脑屏障，靶向并抑制β淀粉样蛋白。这种技术允许大分子在不触发对周围细胞的免疫反应的情况下穿过血脑屏障。图1. Brainshuttle技术支持的trontinemab穿越血脑屏障机制。（图片来源：Neuron） Trontinemab（RG6102）是抗淀粉样蛋白单抗gantenerumab 的新版本。与人类转铁蛋白受体结合的Fab 片段附着在gantenerumab的Fc结构域上。在血液中循环的trontinemab会与构成血脑屏障的内皮细胞上的转铁蛋白受体（TfR1）结合，这会导致其内吞并释放到脑实质中（图1）。在 AD小鼠模型中，与未经修饰的gantenerumab 相比，trontinemab进入大脑并与淀粉样斑块结合的抗体多50倍。Trontinemab可以以远低于gantenerumab的剂量刺激免疫细胞清除斑块，而不会引发对内皮细胞或其他转铁蛋白受体旁观者细胞的免疫反应，这样可以降低潜在的副作用和免疫相关的并发症，而安全性也是阿尔茨海默病单抗开发过程中的重要挑战之一。在经历了阿尔茨海默疗法开发过程中的重重磨难后，罗氏对于trontinemab的期望可想而知。罗氏CEO Thomas Schinecker表示，尽管遭遇了多次阿尔茨海默病的挫折，但罗氏对trontinema的前景“极为乐观”。罗氏将在近期公布trontinema的最新数据。Schinecker信心满满地说：“我们已经知道trontinema会奏效的，我想说可能性相当高。当然，生活中没有保证。”投资者已经开始对罗氏在阿尔茨海默病疗法开发过程中的屡遭挫折表示出了不满，Schinecker此时对trontinema的高度期待在一定程度上也是针对投资者的这些焦虑做出的。罗氏第三季度的五大药物销售驱动来自眼科药物Vabysmo、乳腺癌药物Phesgo、多发性硬化症治疗药物Ocrevus、血友病药物Hemlibra 和血癌药物Polivy。这些药物合计带来了46亿瑞士法郎（约合53亿美元）的收入，同比增长21%。但罗氏的支柱产品肿瘤学药物Tecentriq可能已经达到销售峰值，将逐步面临衰退，在这种情况下，罗氏对于阿尔茨海默病疗法的“十年面部图破壁”的期待将更加强烈。总结阿尔茨海默病治疗的开发过程正面临着多重挑战，这一局面在礼来与罗氏的战略举措中得到了体现。礼来的donanemab在英国的商业化进展遭遇障碍，阿尔茨海默病疗法在完全不同于美国市场的情况下，除非具有相当确定的成本效益，否则将在市场准入方面遭遇巨大挑战。与此同时，罗氏宣布终止与USB的合作项目，这也显示了在Leqembi和Donanemab上市并且未取得众口铄金的局面下，后来者将感受到来自于临床数据的巨大压力。这一系列事件都揭示了阿尔茨海默病疗法开发的复杂局面。在这个存在着巨大未满足的领域，药物开发很容易陷入“尔曹身与名俱灭”的境地。除了令人信服的临床数据之外，市场对疗法的接受度、定价策略及支付方的支持也直接影响到药物的成功推出。虽然这一规律在医药开发领域几乎放之四海而皆准，但对于阿尔茨海默病来说表现尤甚。 Ref. Joseph, A. U.K.’s cost-effectiveness agency says Alzheimer’s drug donanemab does not provide good value. STAT. 23. 10. 2024. Armstrong, A. Roche Trims Another Alzheimer’s Prospect, Ending UCB Collabortion. Biospace. 22. 10. 2024. Jackson, M. UCB Assessing Bepranemab’s Future After Roche/Genentech Ends Partnership. Scrip. 22. 10. 2024. Kresge, N. et al. Roche CEO Is Optimistic on Coming Alzheimer’s Trial Results. Bloomberg. 23. 10. 2024. -END- 2025CMC-CHINA药博会 • 展位火热预定中！各位朋友好，觉得本文对您有帮助，请随手点一下下方的在看，以便让你的朋友也能看到哦。

2024-09-01

·GlobeNewswire-Health Care

Belite Bio Announces Appointment of Hendrik P. N. Scholl, MD, MA, as Chief Medical Officer

Dr. Scholl is a globally recognized leader in the field of ophthalmology and the coordinating principal investigator of the largest ever natural history study of Stargardt disease SAN DIEGO, Sept. 01, 2024 (GLOBE NEWSWIRE) -- Belite Bio, Inc (NASDAQ: BLTE) (“Belite Bio” or the “Company”), a clinical-stage biopharmaceutical drug development company focused on advancing novel therapeutics targeting degenerative retinal diseases that have significant unmet medical needs, today announced that its board of directors has appointed Hendrik P. N. Scholl, MD, MA, as the Chief Medical Officer of the Company, effective immediately. Dr. Scholl is the foremost globally recognized authority on Stargardt disease and age-related macular degeneration (AMD), bringing decades of expertise in treating retinal diseases, including the two key indications targeted by Belite Bio's lead drug candidate, Tinlarebant. “Dr. Scholl has pioneered some of the most significant ophthalmology advancements of our time, and we are incredibly honored and excited to welcome him as our Chief Medical Officer,” said Dr. Tom Lin, Chairman and CEO of Belite Bio. “Dr. Scholl has served as Chair of the Data and Safety Monitoring Board for both our Phase 2 and Phase 3 Stargardt disease trials, and his decision to join Belite further validates our belief in Tinlarebant’s immense potential to improve the lives of patients living with debilitating macular diseases. His leadership, expertise, and commitment to addressing this area of high unmet need has and will continue to be invaluable as we advance our clinical programs.” “I am excited to join Belite Bio at this pivotal time in the Company’s development,” said Dr. Scholl. “I have dedicated my career to improving the lives of people suffering from serious retinal and macular diseases, and I am deeply impressed by Belite Bio’s pioneering approach to developing transformative therapies for Stargardt disease and dry AMD, which have historically lacked effective treatment options. I look forward to working with the team to advance these programs and bring hope to patients around the world.” Dr. Scholl served as the founding and scientific co-director of the Institute of Molecular and Clinical Ophthalmology Basel (IOB) and Professor of Ophthalmology at the University of Basel, where he also led the Department of Ophthalmology as its Chairman. He currently serves as President of the European Vision Institute as well as Chairman of the largest clinical research network in ophthalmology in Europe, EVICR.net, and its Expert Committee on Retinal Dystrophies. He is also the Founder and President of the Swiss Association for Research in Vision and Ophthalmology (ARVO-SWISS). Dr. Scholl’s distinguished career in academia includes leadership positions at several key academic institutions. Recently, he served as Professor of Ophthalmology and Endowed Chair at the Wilmer Eye Institute of Johns Hopkins University Medical School. At the Johns Hopkins Hospital, he was the Head of the Retinal Degeneration Clinic and the Director of the Visual Neurophysiology Service. For the Wilmer Eye Institute, he also served as the Co-director of the Johns Hopkins Center for Stem Cells and Ophthalmic Regenerative Medicine. Dr. Scholl is the coordinating principal investigator of the largest natural history study of Stargardt disease (ProgStar Study), which enrolled 365 subjects. Throughout his career, he has participated in over 10 clinical studies both in Stargardt disease and AMD, authored over 280 articles and reviews in peer-reviewed journals, and received numerous prestigious awards, including the European Vision Award, the President’s Award of the American Society of Retinal Specialists, the W. Richard Green Award and the Paul Henkind Memorial Award of the Macula Society, the Swiss Alfred-Vogt Award, and the Kupfer award of ARVO. He holds an honorary doctorate from Semmelweis University in Budapest, Hungary, and is Adjunct Professor at the Medical University of Vienna, Austria. Over the course of his 25 years of experience, Dr. Scholl has led and participated in numerous boards and advisory committees. He currently serves on the Scientific Advisory Board of Pro Retina Deutschland, Foundation Fighting Blindness, Erasmus University Medical Center, AIBILI, and the Institut de la Vision (Paris); on the Investment Advisory Board of Droia NV; and the Data Safety Monitoring Board of Roche Holding AG and ViGeneron GmbH. Dr. Scholl graduated from the University of Tübingen, Germany with a Doctor of Medicine (Dr. med.) and Master of Arts. He completed his specialist training at the University Eye Hospital in Tübingen before being awarded a fellowship from the German Research Foundation (DFG) at Moorfields Eye Hospital and Institute of Ophthalmology in London, and a DFG Heisenberg Professorship for Macular Diseases at the Eye Clinic of the University of Bonn, Germany. About Belite Bio Belite Bio is a clinical-stage biopharmaceutical drug development company focused on advancing novel therapeutics targeting retinal degenerative eye diseases which have significant unmet medical needs such as Stargardt Disease and Geographic Atrophy in advanced dry age-related macular degeneration (AMD), in addition to specific metabolic diseases. Belite’s lead candidate, Tinlarebant, an oral therapy intended to reduce the accumulation of toxins in the eye, is currently being evaluated in a Phase 3 study (DRAGON) and a Phase 2/3 study (DRAGON II) in adolescent Stargardt subjects and a Phase 3 study (PHOENIX) in subjects with Geographic Atrophy. For more information, follow us on Twitter, Instagram, LinkedIn, Facebook or visit us at www.belitebio.com. Media and Investor Relations Contact:Jennifer Wu : ir@belitebio.com Julie Fallon : belite@argotpartners.com

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2024-07-31

·GlobeNewswire-Health Care

Santhera Appoints Dr. Oliver P. Kronenberg as Chief Legal Officer and Company Secretary

Dr. Kronenberg brings 25 years of legal experience, with 20 years in the pharmaceutical industry Oliver Strub appointed as Head of Compliance Pratteln, Switzerland, July 31, 2024 – Santhera Pharmaceuticals (SIX: SANN) announces the Board of Directors has appointed Dr. Oliver P. Kronenberg as Chief Legal Officer and Corporate Secretary of Santhera Pharmaceuticals AG, effective August 1, 2024. As a member of the executive management team, Dr. Oliver P. Kronenberg will lead the Company's legal strategy and global legal activities, including transactions, corporate governance, and IP. He succeeds Oliver Strub, who remains at Santhera and will assume the newly created role of Head of Compliance, where he will be responsible for overseeing the development, implementation and management of Santhera’s compliance program. “We are pleased to welcome Oliver to Santhera as Chief Legal Officer and as a member of our executive leadership team,” commented Dr. Thomas Meier, Chairman of the Board of Santhera. “His expertise and achievements in key legal areas of the life sciences industry strengthens our leadership team, increasing our expertise in corporate governance and knowledge in the approval and market launch of pharmaceutical products. We extend our deepest thanks to Oliver Strub, who has led Santhera’s legal department since 2006 and will continue as Head of Compliance, where his focus will be on overseeing Santhera’s compliance program.” Dr. Oliver P. Kronenberg is a lawyer with more than 25 years of experience, including over 20 years in the international pharmaceutical industry. Since 2008 he has worked in various roles at Vifor Pharma and its parent company, Galenica. As Head of Legal and Compliance at Vifor Pharma, he was responsible for establishing the legal, IP, and compliance department. In 2013, he was promoted to Group General Counsel of Galenica. After the split of the Galenica Group in April 2017, he returned to Vifor Pharma, becoming Group General Counsel and was appointed member of the executive committee in 2022. Dr. Kronenberg has supported Santhera since April 2024 as interim General Counsel. Dr. Oliver P. Kronenberg commented: “I am excited to be joining Santhera at this important stage of its development, as momentum builds towards the continuous launch of AGAMREE® (vamorolone) for the treatment of Duchenne muscular dystrophy. I look forward to working closely with the executive team and the Board in the months ahead.” Dr. Kronenberg holds a doctorate in law from the University of Basel, an LL.M. degree from the College of Europe in Bruges, Belgium, a degree in Finance for Executives from INSEAD, and an IMD Board Director Diploma. About SantheraSanthera Pharmaceuticals (SIX: SANN) is a Swiss specialty pharmaceutical company focused on the development and commercialization of innovative medicines for rare neuromuscular and pulmonary diseases with high unmet medical need. The Company has an exclusive license from ReveraGen for all indications worldwide to AGAMREE® (vamorolone), a dissociative steroid with novel mode of action, which was investigated in a pivotal study in patients with Duchenne muscular dystrophy (DMD) as an alternative to standard corticosteroids. AGAMREE for the treatment of DMD is approved in the U.S. by the Food and Drug Administration (FDA), in the EU by the European Medicines Agency (EMA), and in the UK by the Medicines and Healthcare products Regulatory Agency (MHRA). Santhera has out-licensed rights to vamorolone for North America to Catalyst Pharmaceuticals and for China to Sperogenix Therapeutics. For further information, please visit www.santhera.com. AGAMREE® is a trademark of Santhera Pharmaceuticals. For further information please contact: public-relations@santhera.com orEva Kalias, Head Investor Relations & CommunicationsPhone: +41 79 875 27 80eva.kalias@santhera.com Disclaimer / Forward-looking statements This communication does not constitute an offer or invitation to subscribe for or purchase any securities of Santhera Pharmaceuticals Holding AG. This publication may contain certain forward-looking statements concerning the Company and its business. Such statements involve certain risks, uncertainties and other factors which could cause the actual results, financial condition, performance or achievements of the Company to be materially different from those expressed or implied by such statements. Readers should therefore not place undue reliance on these statements, particularly not in connection with any contract or investment decision. The Company disclaims any obligation to update these forward-looking statements. # # # Attachment 2024 07 31_CLO_e_final

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