The main objective is to determine the feasibility of dasiglucagon in a bi-hormonal reactive closed loop system for automated glucose regulation (artificial pancreas; AP®) in patients with diabetes mellitus type 1. Safety parameters and pharmacodynamics are compared between Dasiglucagon and GlucaGen®.
This study is a single-center, double-blinded, randomized, cross over trial in 12 subjects. The subjects will be randomized to receive either dasiglucagon or GlucaGen® for the first three day study period and switch to the alternate treatment after a wash-out treatment.

开始日期2023-12-29

申办/合作机构

Inreda Diabetic BV

NCT05378672 / Recruiting临床3期

A Phase 3, Single-administration, Open-label Trial to Assess the Efficacy, Safety, PK, and PD of Dasiglucagon When Administered as a Rescue Therapy for Severe Hypoglycemia in Pediatric Patients Below 6 Years of Age With Type 1 Diabetes

This research study will investigate whether dasiglucagon as a rescue therapy for participants between 1 and 6 years of age works and is safe to use. In addition, the study will investigate how dasiglucagon works in the body (pharmacokinetics and pharmacodynamics).
Participants will receive 1 single dose as an injection under the skin (subcutaneous, s.c.).
Participants will have 3 visits with the study team. For each participant, the study will last up to 84 days.

开始日期2023-05-09

申办/合作机构

Zealand Pharma US, Inc.

NCT04824872 / Withdrawn临床2期

A Double-Blind, Placebo-Controlled, Cross-over Trial, Evaluating Efficacy and Safety of Dasiglucagon for Treatment of Post-bariatric Hypoglycemia in Roux-en-Y Gastric Bypass (RYGB) Operated Adults

The objective of the trial is to assess the effect of single subcutaneous doses of dasiglucagon versus placebo on post-prandial plasma glucose nadir following a Mixed Meal Test in Roux-en-Y Gastric Bypass (RYGB) subjects

开始日期2023-02-01

申办/合作机构

Zealand Pharma US, Inc.

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100 项与达西格列酮相关的专利（医药）

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项与达西格列酮相关的文献（医药）

2023-11-01·The Journal of clinical endocrinology and metabolism

Dasiglucagon for the treatment of congenital hyperinsulinism: a randomised phase 3 trial in infants and children.

Article

作者: Paul S Thornton ; Diva D De Leon ; Susann Empting ; David Zangen ; David M Kendall ; Sune Birch ; Eva Bøge ; Jelena Ivkovic ; Indraneel Banerjee

CONTEXT:

Congenital hyperinsulinism (CHI) is characterised by dysregulated insulin secretion causing hypoglycaemia and consequent brain damage. Dasiglucagon is a glucagon analogue under investigation to treat CHI.

OBJECTIVE:

To evaluate the efficacy and safety of dasiglucagon delivered via continuous subcutaneous infusion to children with CHI and persistent hypoglycaemia as add-on to standard of care (SoC).

METHODS:

In this open-label trial, patients were randomized 1:1 to SoC or SoC + dasiglucagon (10-70 µg/hour) for 4 weeks. In the following 4 weeks, all patients received dasiglucagon + SoC. Hypoglycaemia was assessed by self-monitored plasma glucose (SMPG) and blinded continuous glucose monitoring (CGM). Primary endpoint was average number of SMPG-detected hypoglycaemia episodes/week (SMPG <3.9 mmol/L) during Weeks 2-4.

RESULTS:

Thirty-two patients (0.6-10.9 years) were randomly assigned to dasiglucagon + SoC (n=16) or SoC (n=16). The rate of SMPG-detected hypoglycaemia decreased from baseline in both groups, but with no statistically significant difference during Weeks 2-4 (event rate ratio: 0.85 [0.54; 1.36], p=0.5028). However, dasiglucagon administration resulted in a 43% reduction in CGM-detected hypoglycaemia (<3.9 mmol/L) vs. SoC alone during Weeks 2-4 (post-hoc analysis; event rate ratio: 0.57 [0.39; 0.83], p=0.0029). Dasiglucagon enabled reductions (of 37-61%) in all other measures of hypoglycaemia assessed by CGM vs. SoC alone including extent and %-time in hypoglycaemia (post-hoc analyses). Dasiglucagon appeared safe and well tolerated. Skin and gastrointestinal events were more frequent with dasiglucagon + SoC than SoC only.

CONCLUSION:

Clinically meaningful reductions in all CGM-recorded measures of hypoglycaemia support using dasiglucagon as a potential treatment for CHI.

2023-10-11·Diabetes care

Dasiglucagon Treatment for Postprandial Hypoglycemia After Gastric Bypass: A Randomized, Double-Blind, Placebo-Controlled Trial.

Article

作者: Casper K Nielsen ; Caroline C Øhrstrøm ; Inas J K Houji ; Mads M Helsted ; Liva S L Krogh ; Nicklas J Johansen ; Bolette Hartmann ; Jens J Holst ; Tina Vilsbøll ; Filip K Knop

OBJECTIVE:

Postbariatric hypoglycemia affects >50% of individuals who have undergone Roux-en-Y gastric bypass surgery. Despite the often debilitating nature of this complication, existing treatment options are limited and often inefficient. Dasiglucagon is a stable glucagon analog available in a ready-to-use formulation and was recently shown to mitigate postbariatric hypoglycemia in experimental settings. Here, we aimed to evaluate the hypoglycemic hindering potential of dasiglucagon in an outpatient trial.

RESEARCH DESIGN AND METHODS:

We conducted a randomized, double-blind, placebo-controlled, crossover, proof-of-concept study at the Center for Clinical Metabolic Research at Gentofte Hospital in Denmark. The study included 24 individuals who had undergone Roux-en-Y gastric bypass surgery (n = 23 women) with continuous glucose monitor-verified postbariatric hypoglycemia (≥15 min at <3.9 mmol/L three or more times per week) randomly assigned to two treatment periods of four weeks of self-administered subcutaneous dasiglucagon at 120 μg or placebo. The primary and key secondary outcomes were continuous glucose monitor-captured percentage of time in level 1 and 2 hypoglycemia (<3.9 and <3.0 mmol/L), respectively.

RESULTS:

Compared with placebo, treatment with dasiglucagon significantly reduced time in level 1 hypoglycemia by 33% (-1.2 percentage points; 95% CI -2.0 to -0.5; P = 0.002) and time in level 2 hypoglycemia by 54% (-0.4 percentage points; 95% CI -0.6 to -0.2; P < 0.0001). Furthermore, dasiglucagon corrected hypoglycemia within 15 min in 401 of 412 self-administrations, compared with 104 of 357 placebo self-administrations (97.3% vs. 29.1% correction of hypoglycemia rate; P < 0.001). Dasiglucagon was generally well tolerated, with mostly mild to moderate adverse events of nausea.

CONCLUSIONS:

Compared with placebo, four weeks of self-administered dasiglucagon effectively reduced clinically relevant hypoglycemia in individuals who had undergone Roux-en-Y gastric bypass surgery.

2023-04-11·Diabetologia

Pen-administered low-dose dasiglucagon vs usual care for prevention and treatment of non-severe hypoglycaemia in people with type 1 diabetes during free-living conditions: a Phase II, randomised, open-label, two-period crossover trial.

Article

作者: Christian Laugesen ; Ajenthen G Ranjan ; Signe Schmidt ; Kirsten Nørgaard

AIMS/HYPOTHESIS:

Consumption of excess carbohydrates to manage hypoglycaemia can lead to rebound hyperglycaemia and promote weight gain. The objective of this trial was to evaluate the efficacy, safety and feasibility of pen-administered low-dose dasiglucagon for prevention and treatment of non-severe hypoglycaemia in people with type 1 diabetes during free-living conditions.

METHODS:

Twenty-four adults with insulin pump-treated type 1 diabetes (HbA_1c ≤70 mmol/mol [8.5%]) completed a randomised, open-label, two-period crossover study with 2 week periods. During the usual care and dasiglucagon intervention (DASI) periods, participants managed impending and manifested episodes of hypoglycaemia with regular carbohydrate consumption or pen-administered low-dose (80 μg) s.c. dasiglucagon, respectively. Glycaemic control was evaluated using continuous glucose monitoring (Dexcom G6) and event registration of prevention and treatment episodes.

RESULTS:

Compared with usual care, the mean difference (95% CI) in the DASI period for time in (3.9-10.0 mmol/l) and below (<3.9 mmol/l) range was 2.4 %-points (-0.7, 5.5) and -0.5 %-points (-1.2, 0.2), respectively. In the DASI period, recovery rate (time from hypoglycaemia treatment to euglycaemia) was 44% (11, 87) faster while total daily carbohydrate intake was reduced by 11% (-18, -3). Dasiglucagon use was safe and well tolerated with mild nausea being the most frequent adverse effect. Among the participants, 96% (p<0.0001) were likely to include dasiglucagon in their future routine management of hypoglycaemia.

CONCLUSIONS/INTERPRETATION:

Use of low-dose dasiglucagon to prevent and treat non-severe hypoglycaemia during free-living conditions was safe, fast and efficacious while significantly reducing the total daily carbohydrate intake and yielding high treatment satisfaction.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT04764968 FUNDING: The study was an investigator-initiated trial. Zealand Pharma supplied the investigational drug and device and provided financial support for the conduct of the trial.

项与达西格列酮相关的新闻（医药）

2024-04-02

·药融圈

商业化的残酷性：减重赛道明星公司也曾裁员90%，换CEO…

▲5月30-31日第八届广州生物医药创新者峰会扫码立即报名注：本文不构成任何投资意见和建议，以官方/公司公告为准；本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及），不代表平台立场。任何文章转载需得到授权。接药融圈上篇《减重赛道巨头林立，丹麦多肽公司Zealand何以成为“关键参与者”？》丹麦多肽公司Zealand Pharma现已是减重赛道的明星公司，但曾屡次在商业化方面碰壁。创新是高风险的，面对现实的残酷性，Zealand的策略是积极寻找合作伙伴，出售产品权益或对外授权，并精简运营，专注于研发。Zealand开发的Zegalogue（Dasiglucagon）是一种新型人胰高血糖素样肽（GLP-1）类似物，2021年3月获得美国FDA批准用于治疗6岁及以上糖尿病患者的严重低血糖，该病是一种急性的、危及生命的疾病，主要由胰岛素治疗相关的血糖水平下降引起。Zegalogue（Dasiglucagon）是首个获批该适应症的GLP-1类似物，可在10分钟之内逆转低血糖状况，Zealand公司还为此开发了自动注射器HypoPal以便患者自我给药，可在室温储存。该产品自2021年6月在美国上市销售，但业绩表现不佳，2022年3月，Zealand宣布在美国的办事处裁员90%，并将其年度运营费用削减至少35%，甚至更换了CEO。这家biotech感受到了商业化的残酷性，希望为自己的产品找到销售合作伙伴。2022年9月，Zealand与诺和诺德就Zegalogue（Dasiglucagon）达成全球许可和开发协议，根据协议，诺和诺德将负责该产品的全球商业化，Zealand将收到2500万丹麦克朗的预付款，并有资格获得4500万丹麦克朗的近期开发、监管和制造里程碑付款。Zealand还有资格获得高达2.2亿丹麦克朗的销售里程碑和分级特许权使用费。同时，Zealand还将继续负责某些计划中的监管、开发和制造活动，以支持该产品在美国以外地区的进一步开发和批准。截图自药融云数据库另一款已上市产品V-Go是一种可穿戴式胰岛素输送设备，适用于需要使用胰岛素的成人患者，以消除每日多次注射的需要。V-Go的商业化也是一波三折，据了解，V-Go来自于早前Zealand以2300万美元收购的Valeritas公司，但该产品同样销售表现不佳，开发出V-GO设备的Valeritas在当时便申请了破产，面对定价压力和竞争激烈的市场条件，V-GO在多个国家的分销协议也在很早就被终止了。最后Zealand也未能成功将该产品商业化，2022年5月，Zealand以1000万美元的价格将V-Go设备卖给了MannKind公司，另外，Zealand还有资格获得基于V-Go销售业绩的里程碑付款。（相关阅读：可穿戴胰岛素梦碎，西兰制药半价抛售V-GO给MannKind）另外，GLP-1RA（胰高糖素样肽-1受体激动剂）利司那肽是Zealand原研的产品。2003年，Zealand将利司那肽在糖尿病领域的开发与商业化许可授予了赛诺菲，包括单药治疗和联合疗法。根据该协议，Zealand有权获得利司那肽（欧洲商品名Lyxumia/美国商品名Adlyxin），以及甘精胰岛素和利司那肽复方制剂（美国商品名Soliqua 100/33/欧洲商品名Suliqua）全球净销售额相关的特许权使用费和商业里程碑付款。不过貌似Zealand对赛诺菲推出的这两款产品的销售表现以及所得款项并不满意，于是决定将该资产变现。2018年9月，新药特许权公司Royalty Pharma宣布以2.05亿美元现金从Zealand手中收购了前述两款产品的未来特许权使用费以及潜在的商业里程款项。此次交易让Zealand获得了财务上的确定性与独立性，后续利司那肽及相关产品也就不在Zealand的管线资产中了。Zealand着眼于全球多肽药物市场，在所有已上市产品的权益都已出售或对外授权之后，Zealand正将精力集中于产品的研发，依托专有的多肽药物开发技术，改善疾病的治疗标准。该公司的研发支出占总运营开支的约80%。近几年，制药领域最为火热的莫过于减重赛道。肥胖既是一场个人的战斗，也是一场公共健康危机。世卫组织估计，全球有超过10亿人患有肥胖症。据摩根士丹利预测，到2030年，全球肥胖市场将达到770亿美元。2023年，《科学》杂志将胰高血糖素样肽-1（GLP-1）受体激动剂的开发以及可缓解肥胖相关健康问题的药物列为年度突破之首。药融云数据（www.pharnexcloud.com）监测显示：目前公司在研的减重领域候选分子有长效GLP-1R/GLP-2R双重激动剂Dapiglutide；Petrelintide（ZP8396），一款潜在best in class的长效胰淀素类似物；Survodutide（BI-456906）；等等。此文仅用于向医疗卫生专业人士提供科学信息，不代表平台立场，不作任何用药推荐参考：NMPA/CDE；药融云数据www.pharnexcloud.com；FDA/EMA/PMDA；相关公司公开披露（正文图片均来自企业官方，除非另有说明）；https://www.zealandpharma.com/；https://www.fiercepharma.com/marketing/zealand-underwhelmed-by-sanofi-s-soliqua-sales-plans-to-ride-solo-future-launches；https://www.royaltypharma.com/news/royalty-pharma-announces-205-million-acquisition-zealand-pharmas/；等等本文仅用于向医疗卫生专业人士提供科学信息，不代表平台立场，不作任何用药推荐活动推荐 5月 • 第八届大湾区生物医药创新者峰会关键词：小分子，XDC，多肽及GLP-1热点话题，80+行业专家（点击下方图片查看详情）▼【关于药融圈】药融圈PRHub旨在帮助生物医药科技型企业进行品牌推广及商务拓展服务，针对客户的真实需求制定系统化解决方案，通过“翻译-降维-场景化”将客户的品牌信息以直白易懂的方式被公众知悉，同时在流量渠道覆盖100万+垂直用户基础上实现合作目的，帮助合作伙伴完成从品牌开始到商务为终的闭环营销服务。我们已经完成了数十场线下1000人规模的生物医药研发类会议，涵盖小分子新药，大分子新药，改良型新药，BD跨境交易等多个领域，服务了百余家上市/独角兽/生物技术/制药企业。

并购生物类似药

2024-03-04

·药融圈

减重赛道巨头林立，丹麦多肽公司Zealand何以成为“关键参与者”？

3月7-8日生物医药创新者峰会 · 点击报名注：本文不构成任何投资意见和建议，以官方/公司公告为准；本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及），不代表平台立场。任何文章转载需得到授权。世界肥胖联盟(World Obesity Federation, WOF)于2020年宣布将每年的3月4日确定为“世界肥胖日”。也就是文章发布的今天。近段时间，制药领域最为火热的莫过于减重赛道。肥胖既是一场个人的战斗，也是一场公共健康危机。世卫组织估计，全球有超过10亿人患有肥胖症。据摩根士丹利预测，到2030年，全球肥胖市场将达到770亿美元。2023年，《科学》杂志将胰高血糖素样肽-1（GLP-1）受体激动剂的开发以及可缓解肥胖相关健康问题的药物列为年度突破之首。减重赛道爆火的同时，资本与企业扎堆入局这一“吸金赛道”，丹麦诺和诺德与美国礼来作为减重领域当之无愧的先行者，无疑将占据大部分市场份额，那么其他中小型制药公司的机会在哪里？药融云数据www.pharnexcloud.com显示，丹麦生物技术公司Zealand Pharma A/S专注于创新多肽药物的发现、设计和开发，产品线主要集中于胃肠道和代谢疾病，并已将临床开发资产扩展到了罕见病领域。该公司的合作伙伴包括赛诺菲、诺和诺德、勃林格殷格翰等知名药企。Zealand被称为是减重领域的“关键参与者”。Zealand成立于1998年，总部位于丹麦哥本哈根，并在美国设有办事处，截至2023年底，在全球拥有260名员工。该公司的创始人之一Lars Hellerung Christiansen在生物技术和制药领域拥有30多年的连续创业经验；另一位创始人Bjarne Due Larsen博士则是公司SIP®多肽增强技术的发明者；创始CEO Eva Steiness博士曾是丹麦灵北制药第一位女性研究总监，被称为“喜普妙之母”。（喜普妙/Cipramil指氢溴酸西酞普兰片）截图自药融云数据库据彭博社报道，Zealand公司2023年在哥本哈根证券交易所的市值上涨了63%，而同为丹麦制药公司，且更庞大、更知名的诺和诺德则上涨了40%。（这两家公司的总部仅相距几英里）有分析师预测，该公司2024年的市值涨幅或将再次超越诺和诺德。根据企业公开信息，Zealand公司截至2023年12月31日的市值为219亿丹麦克朗（约33亿美元）。另据companiesmarketcap.com统计，截至本文成稿的2024年2月20日，该公司市值达到了43.2亿美元。图源：Bloomberg目前，该公司的领导团队亦带有“减重双雄”诺和诺德与礼来的基因，2022年新任命的总裁兼首席执行官Adam Steensberg博士曾在诺和诺德担任医学总监，领导临床研究团队；首席医学官David Kendall博士曾是礼来公司的医学事务副总裁和杰出医学研究员、MannKind公司的首席医疗官。首席执行官Adam Steensberg博士曾表示，减肥药将在未来50年内将无处不在，世界上很多人都将服用减肥药。Zealand公司目前的核心专长是通过修饰和优化天然肽的结构来改善其治疗特性，包括增强生物活性、延长作用持续时间并增加稳定性，从而为多种疾病提供创新和更好的治疗方法。该公司的SIP®多肽增强技术将一些特定的氨基酸添加到肽中，从而加强或收紧分子结构，使肽不易被生物降解。该技术有助于多肽在血液中维持较长时间，从而延长多肽药物的给药间隔，GLP-1RA利司那肽就是基于该技术开发（其整个专利家族都独家授权给了赛诺菲）。截至目前，Zealand的产品管线中已有10多款候选疗法进入临床研究阶段，其中2款已进入市场，3款候选药物处于临床后期开发阶段。同时，该公司与多家制药公司建立了开发合作伙伴关系，并就其已上市产品建立了商业合作伙伴关系。在肥胖领域实现“有意义的减肥”当前的肥胖领域为Zealand带来了历史性的机遇，为了成为肥胖症领域的关键参与者，Zealand的理念是实现“有意义的减肥”并解决与肥胖相关的长期并发症（如NASH）。Zealand认为减肥药物的开发应当着眼于对减肥的质量以及对并发症的影响，而非单纯的减重，未来减肥药物的成功与否是从多方面进行考量的，如肥胖相关并发症、胃肠道副作用与耐受性、肌肉质量的保留、给药方案的便利性、应用的灵活性。2023年12月5日，Zealand举办了肥胖症研发日活动，介绍了公司差异化候选产品的科学原理和临床潜力。01长效GLP-1R/GLP-2R双重激动剂Dapiglutide是一款潜在first in class的长效GLP-1R/GLP-2R双重激动剂。1期临床研究显示，Dapiglutide在健康人群中可在四周内使平均体重减轻4.3%，其半衰期为123-129小时，有可能实现每周一次给药。GLP-1（胰高血糖素样肽-1）可降低食欲、延缓胃排空并调节血糖控制，GLP-2（胰高血糖素样肽-2）可帮助肠道修复，并对其他器官也有潜在的益处。动物研究显示，GLP-1R/GLP-2R双激动剂可减少肝脂肪变性、炎症和纤维化，并降低了饮食引起的肥胖小鼠的体重，改善身体成分。肥胖人群体内常存在低度炎症，这会导致一些相关的合并症，Dapiglutide的结构设计对GLP-1R具有较高的效力，同时保留对GLP-2R的活性，因此可同时治疗肥胖及低度炎症。2023年初，一项研究者主导的2期临床试验（DREAM）启动，该研究旨在评估Dapiglutide对体重、肠道通透性和炎症的影响，计划入组54位患者，研究为期12周，预计将在2024年上半年公布结果；另一项为期13周的1b期剂量调整试验正在进行中，预计将在2024年下半年公布结果。02长效胰淀素类似物当下备受关注的GLP-1RA类药物虽然减重效果明显，但在耐受性方面存在缺陷，常见的胃肠道副作用包括恶心和呕吐。这类药物本被用作治疗2型糖尿病，在过去因为治疗选择有限，对于许多超重或肥胖的人来说，GLP-1RA类药物疗效的强大已经盖过其耐受性问题。但是未满足的需求依然存在，患者需要非肠促胰岛素机制的药物，从而提高耐受性，以获得更好的患者体验并实现高质量减肥。基于此，Zealand开发了Petrelintide（ZP8396），一款潜在best in class的长效胰淀素类似物，其结构衍生自人胰淀素，是一种由36个氨基酸组成的酰化肽，在中性pH下具有稳定性，半衰期为10天，适合每周一次给药。天然的胰淀素是一种非肠促胰岛素肽，与GLP-1相比能够增加饱腹感，从而降低食欲。从概念上讲，与单纯抑制食欲相比，增加饱腹感可以使患者在减肥期间获得更好的体验。临床前研究表明，胰淀素激动剂可促进脂肪质量减少以及瘦质量的相对保存。因此胰淀素类似物有潜力成为未来独立的一类减肥药物，凭借非肠促胰岛素机制或将提高耐受性，降低心血管疾病风险。1期临床研究显示，单次皮下注射2.4 mg剂量Petrelintide可在第7天使平均体重减轻4.2%；每周一次，6次注射低剂量（0.6 mg、1.2 mg）的Petrelintide可使平均体重减轻5%以上。1期临床的后半部分，16周以上高剂量Petrelintide的数据将在2024年上半年获得，预计2024年下半年启动的全面的2期临床研究。03GCGR/GLP-1R双重激动剂Survodutide（BI-456906）是一种由29种氨基酸组成的多肽，其结构衍生于胃泌酸调节素（OXM），具有对GCG（胰高血糖素）和GLP-1受体的双重激动作用。该候选药物由Zealand与勃林格殷格翰联合开发，由勃林格殷格翰负责临床开发和商业化。OXM是一种能通过增加能量消耗和调节食欲来减轻体重的激素，由于半衰期较短，临床应用受限。Survodutide通过氨基酸替代延长了半衰期，可实现每周一次给药，且经过故意设计，对GLP-1受体有强烈的偏倚（8：1受体偏倚vs胰高血糖素）。在一项为期16周的2型糖尿病2期临床试验中，Survodutide有效降低了患者糖化血红蛋白和体重；在一项为期46周的肥胖2期临床试验中，Survodutide高剂量（4.8 mg）给药使患者体重平均减少了18.7%，平均血压降低了8.6mmHg（收缩压）和4.8mmHg（舒张压）。Survodutide治疗肥胖症的3期临床研究SYNCHRONIZE已启动，2023年8月由勃林格殷格翰在中国与全球同步递交3期临床试验申请。截图自药融云数据库Zealand最为关注的不是“减少重量”（weight loss），而是“增加健康”（health gain），该公司认为肥胖是一系列的疾病。肥胖与严重的共病相关（如精神疾病、肺病、肝病、皮肤病、心血管疾病、肾病、肿瘤），因此有显著的医疗需求未得到满足。其中，肥胖和肝病之间有明显的重叠。2024年2月26日，勃林格殷格翰宣布，在一项2期临床试验中，与安慰剂组（18.2%）相比，接受Survodutide治疗的成人患者中，高达83.0%的患者在治疗48周后在代谢功能障碍相关脂肪性肝炎（MASH）方面取得了统计学上的显著改善。该试验达到其主要和关键次要终点。Survodutide有望成为MASH的best-in-class疗法。【非酒精性脂肪性肝炎（NASH）已更名为代谢功能障碍相关脂肪性肝炎（MASH）】Zealand预计到2030年代，Survodutide有潜力成为含有GLP-1的主要减肥药物。Survodutide (BI 456906) II期试验数据显示，超重或肥胖受试者体重下降接近19%此外，Zealand还拥有一款GIP（葡萄糖依赖性促胰岛素多肽）受体激动剂ZP6590处于临床前研究阶段，当与其他多肽药物如GLP-1受体激动剂联用时，ZP6590的止吐特性能提高药物的耐受性，并潜在增强减肥效果。罕见病的机会Zealand管线中进度最领先的是两项罕见病资产。Dasiglucagon是一种新型人胰高血糖素样肽（GLP-1）类似物，已获美国FDA批准治疗6岁及以上糖尿病患者的严重低血糖，并由诺和诺德负责该产品的全球商业化，商品名Zegalogue。Zealand还将该药开发用于预防和治疗患有先天性高胰岛素血症（CHI）的婴儿和儿童的低血糖症，并与DEKA Research & Development Corp.合作开发了Dasiglucagon的可穿戴式皮下注射泵。Zealand于2023年向FDA递交了该产品的NDA申请，后因第三方制造缺陷遭推迟。该审查分为两个部分，Zealand预计在2024年上半年向FDA重新提交与三周给药相关的第1部分和与长期使用相关的第2部分。化合物专利美国到2035年，欧盟到2039年。Glepaglutide是一种长效稳定的GLP-2（胰高血糖素样肽-2）类似物，半衰期达88个小时，设计为每周两次注射10 mg剂量，采用自动注射器，旨在减少或消除短肠综合征（SBS）患者对肠外营养支持（PS）的需求。SBS是一种罕见的、慢性和衰弱的疾病，导致肠道吸收能力受损，该病与重大的医疗并发症有关，包括肝肾衰竭、代谢并发症、慢性疲劳，以及危及生命的感染，在美国和欧洲影响多达4万人。3期临床研究显示，与安慰剂相比，Glepaglutide在第24周显著降低了每周肠外营养支持（PS）的量。药融云数据www.pharnexcloud.com显示，美国FDA已授予Glepaglutide用于治疗SBS的孤儿药资格。2023年12月22日，Zealand宣布向美国FDA递交Glepaglutide的NDA申请，用于治疗依赖肠外营养支持的短肠综合征成人患者。截图自药融云数据慢性炎症& 1型糖尿病Zealand的临床前管线针对医疗需求未得到满足的慢性炎症性疾病：补体C3抑制剂ZP10068由Zealand与阿斯利康旗下Alexion联合开发，Zealand在2023年完成了支持推动ZP10068进入临床研究的活动，后续所有监管、临床和开发工作将由Alexion领导进行，Zealand将有资格获得高达6.1亿美元的潜在开发、监管和商业里程碑付款以及基于净销售的特许权使用费。Kv1.3阻滞剂ZP9830针对广泛的慢性炎症性疾病，对促炎细胞因子的释放具有浓度依赖性抑制。α4β7整合素抑制剂ZP10000是Zealand开发的口服多肽项目，可减少临床前IBD（炎症性肠病）疾病模型中的结肠病变和炎症。针对1型糖尿病（T1D），Zealand的目标是通过GLP-1类似物Dasiglucagon的应用来改变T1D疾病管理的范式，目前分别开发了用于严重低血糖、运动性低血糖、自动血糖管理的产品。财务状况从历史上看，Zealand所有的收入都来自于里程碑付款、与许可和资产出售协议相关的特许权使用费，以及V-Go和Zegalogue（Dasiglucagon）在美国的销售收入。在所有已上市产品的权益都已出售或对外授权之后，预计其未来收入将来自于相关的里程碑付款和特许权使用费。2022年Zealand的许可和合作协议收入为1.04亿丹麦克朗（约1507万美元），运营开支为9.41亿丹麦克朗（1.36亿美元），预计2023年运营开支约为8-9亿丹麦克朗（1.16-1.3亿美元）。【汇率按照1美元=6.9丹麦克朗】2023年前三季度，Zealand总收入达到了3.196亿丹麦克朗（4632万美元），主要来自于勃林格殷格翰（Survodutide）、赛诺菲（利司那肽）的里程碑付款，以及诺和诺德[Zegalogue（Dasiglucagon）]的合作收入。同时，前三季度总运营费用为6.33亿丹麦克朗（9174万美元），略低于上一年，这是由于2022年3月宣布重组后，努力降低成本，以及一般管理费用下降，部分被更高的研发费用抵消，78%的运营费用分配给研发，这是由于临床后期罕见病项目的监管递交和肥胖管线的临床进展。截至2023年9月30日，Zealand拥有现金19.32亿丹麦克朗（2.8亿美元）。此文仅用于向医疗卫生专业人士提供科学信息，不代表平台立场，不作任何用药推荐参考：NMPA/CDE；药融云数据www.pharnexcloud.com；FDA/EMA/PMDA；相关公司公开披露（正文图片均来自企业官方，除非另有说明）；https://www.zealandpharma.com/；https://news.un.org/zh/story/2022/03/1100142；https://paper.sciencenet.cn/htmlnews/2023/12/514347.shtm；https://fortune.com/europe/2023/12/13/novo-nordisk-has-been-outgained-by-smaller-and-local-pharma-rival/；https://www.bnnbloomberg.ca/much-of-the-world-will-take-obesity-drugs-in-50-years-biotech-firm-says-1.2019057；等等活动推荐 3月 • NDC x 2024新药创新者峰会关键词： ADC，改良型新药，小分子新药，GLP-1药物（点击下方图片查看详情）▼【关于药融圈】药融圈PRHub旨在帮助生物医药科技型企业进行品牌推广及商务拓展服务，针对客户的真实需求制定系统化解决方案，通过“翻译-降维-场景化”将客户的品牌信息以直白易懂的方式被公众知悉，同时在流量渠道覆盖100万+垂直用户基础上实现合作目的，帮助合作伙伴完成从品牌开始到商务为终的闭环营销服务。我们已经完成了数十场线下1000人规模的生物医药研发类会议，涵盖小分子新药，大分子新药，改良型新药，BD跨境交易等多个领域，服务了百余家上市/独角兽/生物技术/制药企业。

高管变更

2024-02-27

·BioSpace

Zealand Pharma Announces Financial Results for the Full Year 2023

Company announcement - No. 9 / 2024 Zealand Pharma Announces Financial Results for the Full Year 2023 Significant progress delivered across our obesity and rare disease assets while building a solid financial position Positive results achieved for petrelintide in 6-week Phase 1 trial and clinical advancement of dapiglutide and petrelintide towards obesity data readouts in 2024 Positive results announced in Boehringer Ingelheim Phase 2 clinical trials for survodutide in obesity and global Phase 3 clinical program in obesity initiated NDA submissions for dasiglucagon in congenital hyperinsulinism and glepaglutide in short bowel syndrome expected to support regulatory decisions for rare diseases in 2024 Private placement of shares to institutional investors, European Investment Bank loan facility, undrawn committed RCF and milestone payments from existing partners contribute to strengthened financial position Events after the reporting period Positive results announced in Boehringer Ingelheim Phase 2 clinical trial for survodutide in MASH and private placement of shares to institutional investors contribute to extended cash runway into 2027 Copenhagen, Denmark, February 27, 2024 – Zealand Pharma A/S (Nasdaq: ZEAL) (CVR-no. 20045078), a biotechnology company focused on the discovery and development of innovative peptide-based medicines, today announced the annual report for the year ended December 31, 2023, and provided a corporate update. Building momentum in 2024 “2023 was an extraordinary year for Zealand and I am proud of our team’s performance to progress our business,” said Adam Steensberg, President and Chief Executive Officer at Zealand Pharma. “With the promising results for our long-acting amylin analog, petrelintide, and the advancement of our dual GLP-1/GLP-2 receptor agonist, dapiglutide, in obesity, Zealand is well positioned to achieve significant milestones in 2024. We look forward to important clinical results for petrelintide and dapiglutide in obesity that we believe will support advancing both compounds into subsequent Phase 2b trials, and to progressing our rare disease product candidates through the regulatory phase to patients who need them.” Key financial results for FY 2023 DKK million FY 2023 FY 2022 Revenue 342.8 104.0 Net operating expenses1 -895.9 -941.1 Net operating result -572.2 -837.2 Net financial items -136.6 -134.9 Cash position2 1,633.1 1,177.8 Cash position including undrawn committed RCF3, EIB4 loan facility (Tranche A, B and C) and January 2024 private placement5 4,104.0 1,177.8 Notes: Net operating expenses consist of R&D, S&M, G&A and other operating items. Cash position includes cash, cash equivalents and marketable securities. RCF = Revolving Credit Facility of DKK 350 million provided by Danske Bank. EIB = European Investment Bank. The conditions for Tranche A (EUR 50 million) have been met. Pay-out expected in Q1 2024. Tranche B (EUR 20 million) and Tranche C (EUR 20 million) are subject to predefined milestones being met. In January 2024, Zealand received gross proceeds of DKK 1.45 billion in connection with a private placement of new shares. Maintaining a strong financial position. Revenue in 2023 of DKK 343 million was mainly driven by a EUR 30 million milestone payment from Boehringer Ingelheim associated with survodutide and USD 10 million from a milestone payment from Sanofi associated with lixisenatide. Cash position is DKK 4.1 billion including the undrawn committed RCF, the EIB loan facility (tranche A, B and C) and the January 2024 private placement of DKK 1.45 billion. Cash, cash equivalents and marketable securities as of December 31, 2023, was DKK 1.6 billion, including gross proceeds of DKK 1.5 billion from a directed issue and private placement in April 2023. Under the current assumptions Zealand projects its existing financial resources will be sufficient to fund operations into 2027. Financial guidance for 2024 The solid financial situation enables Zealand to expand its investments in the company’s wholly owned obesity assets and continue investing in progressing the rare disease product candidates through the regulatory phase while engaging in partnership discussions. DKK million 2024 Guidance 2023 Actual Revenue anticipated from existing and new license and partnership agreements No guidance due to uncertain size and timing 343 Net operating expenses5 1,100-1,200 896 Notes: 5. Financial guidance based on foreign exchange rates as of February 26, 2024. Recent R&D highlights and key events anticipated in 2024 Obesity – advancing the portfolio Petrelintide, a long-acting amylin analog. At Obesity Week in November 2023, Zealand presented results from Part 1 of the Phase 1b MAD trial (NCT05613387), in which low doses of up to 1.2 mg petrelintide administered once weekly for six weeks led to reductions in body weight of up to 5.3% in healthy lean and overweight participants (mean body weight of 82 kg and BMI of 25.4). Petrelintide was well tolerated in the trial with a mostly mild adverse event profile. In the first half of 2024, Zealand expects to report topline results from Part 2 of the MAD trial designed to evaluate higher doses of petrelintide administered for 16 weeks in participants with overweight or obesity (eligible BMI 27.0–39.9). In parallel, Zealand is planning a Phase 2b trial of petrelintide planned for initiation in the second half of 2024. Dapiglutide, a first-in-class GLP-1/GLP-2 receptor dual agonist: In the first half of 2024, Zealand anticipates topline results from the Phase 2a investigator-led DREAM trial (NCT05788601) designed to evaluate the potential for weight loss following 12 weeks of treatment with dapiglutide and gain key mechanistic insights into effects on inflammatory markers. In the second half of 2024, Zealand expects topline results from the Phase 1b 13-week dose titration trial (NCT06000891) designed to evaluate dapiglutide in otherwise healthy participants with overweight or obesity (eligible BMI 27.0–39.9). In this trial, higher maximum maintenance doses are planned than were used in the prior 4-week MAD trial and ongoing DREAM trial. Survodutide, a glucagon/GLP-1 receptor dual agonist. In February 2024, Boehringer Ingelheim and Zealand Pharma announced positive results from the Phase 2 trial of survodutide in metabolic dysfunction-associated steatohepatitis (MASH), previously known as nonalcoholic steatohepatitis (NASH). The topline results showed that up to 83.0% of adults treated with survodutide achieved a biopsy-proven improvement in MASH (stages F1, F2 and F3) after 48 weeks, versus 18.2% with placebo [response difference: 64.8% (CI 51.1% - 78.6%), p-value (p<0.0001)]. Boehringer expects to present these results at a scientific congress in the first half of 2024. In a Phase 2 trial in people living with overweight or obesity, survodutide achieved up to 18.7% mean weight loss from baseline after 46 weeks. The full data were presented at the 2023 American Diabetes Association’s (ADA) 83rd Scientific Sessions. Boehringer is currently evaluating survodutide in Phase 3 clinical trials, including SYNCHRONIZE™-1 and SYNCHRONIZE™-2, enrolling people living with overweight or obesity without and with type 2 diabetes, respectively, and SYNCHRONIZE™-CVOT, a long-term cardiovascular safety trial in people living with overweight or obesity with cardiovascular disease, chronic kidney disease or with risk factors for cardiovascular disease. Rare diseases – progressing towards patients Dasiglucagon in congenital hyperinsulinism (CHI). In the first half of 2024, Zealand expects to resubmit the New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the prevention and treatment of hypoglycemia in pediatric patients seven days of age and older with CHI for up to three weeks of dosing. The resubmission is in response to a Complete Response Letter issued by the FDA in December 2023 related to deficiencies identified at a third-party manufacturing facility that are not specific to dasiglucagon. Also in the first half of 2024, to support use of dasiglucagon beyond three weeks, the company plans to submit additional analyses, requested by the FDA, from existing continuous glucose monitoring (CGM) datasets that were included as a secondary outcome measure in the Phase 3 program. Zealand plans to make dasiglucagon available to healthcare professionals and patients upon regulatory approval and expects to identify a partner for future commercialization. Glepaglutide in short bowel syndrome (SBS). In December 2023, Zealand submitted an NDA to the U.S. FDA for the treatment of adult patients with SBS dependent on parenteral support. The company expects to receive notification of a PDUFA date in the coming weeks following acceptance of the filing. Zealand anticipates identifying a partner for future commercialization of glepaglutide. Chronic inflammation – initiating first-in-human trials ZP10068, Complement Inhibitor. As part of the discovery and development collaboration with Alexion, Zealand has completed pre-clinical and CMC activities for the investigational long-acting complement inhibitor. Subsequent regulatory, clinical and development efforts will be led and conducted by Alexion. ZP9830, Kv1.3 Ion Channel Blocker. Zealand expects to initiate first-in-human clinical trials in 2024. Conference call today at 2 PM CET / 8 AM ET Zealand’s management will host a conference call today at 2:00 PM CET / 8:00 AM ET to present results for the full year 2023 followed by a Q&A session. Participating in the call will be Chief Executive Officer, Adam Steensberg; Chief Financial Officer, Henriette Wennicke; and Chief Medical Officer, David Kendall. The conference call will be conducted in English. The live listen-only audio webcast of the call and accompanying slide presentation will be accessible at . To receive telephone dial-in information and a unique personal access PIN, please register at . Participants are advised to register for the call or webcast approximately 10 minutes before the start. A recording of the event will be available following the call on the Investor section of Zealand’s website at . About Zealand Pharma A/S Zealand Pharma A/S (Nasdaq: ZEAL) (“Zealand”) is a biotechnology company focused on the discovery and development of peptide-based medicines. More than 10 drug candidates invented by Zealand have advanced into clinical development, of which two have reached the market and three candidates are in late-stage development. The company has development partnerships with a number of pharma companies as well as commercial partnerships for its marketed products. Zealand was founded in 1998 and is headquartered in Copenhagen, Denmark, with a presence in the U.S. For more information about Zealand’s business and activities, please visit . Forward-Looking Statements This company announcement and associated annual report contain “forward-looking statements”, as that term is defined in the Private Securities Litigation Reform Act of 1995 in the United States, as amended, even though no longer listed in the United States this is used as a definition to provide Zealand Pharma’s expectations or forecasts of future events regarding the research, development and commercialization of pharmaceutical products, the timing of the company’s pre-clinical and clinical trials and the reporting of data therefrom and the company’s Key Events Anticipated and Financial Guidance for 2024. These forward-looking statements may be identified by words such as “aim,” “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “plan,” “possible,” “potential,” “will,” “would” and other words and terms of similar meaning. You should not place undue reliance on these statements, or the scientific data presented. The reader is cautioned not to rely on these forward-looking statements. Such forward-looking statements are subject to risks, uncertainties and inaccurate assumptions, which may cause actual results to differ materially from expectations set forth herein and may cause any or all of such forward-looking statements to be incorrect, and which include, but are not limited to, unexpected costs or delays in clinical trials and other development activities due to adverse safety events, patient recruitment or otherwise; unexpected concerns that may arise from additional data, analysis or results obtained during clinical trials; our ability to successfully market both new and existing products; changes in reimbursement rules and governmental laws and related interpretation thereof; government-mandated or market-driven price decreases for our products; introduction of competing products; production problems at third party manufacturers; dependency on third parties, for instance contract research or development organizations; unexpected growth in costs and expenses; our ability to effect the strategic reorganization of our businesses in the manner planned; failure to protect and enforce our data, intellectual property and other proprietary rights and uncertainties relating to intellectual property claims and challenges; regulatory authorities may require additional information or further studies, or may reject, fail to approve or may delay approval of our drug candidates or expansion of product labeling; failure to obtain regulatory approvals in other jurisdictions; exposure to product liability and other claims; interest rate and currency exchange rate fluctuations; unexpected contract breaches or terminations; inflationary pressures on the global economy; and political uncertainty, including the ongoing military conflict in Ukraine and the uncertainty surrounding upcoming elections in the US. If any or all of such forward-looking statements prove to be incorrect, our actual results could differ materially and adversely from those anticipated or implied by such statements. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from our expectations in any forward-looking statement. All such forward-looking statements speak only as of the date of this company announcement and are based on information available to Zealand Pharma as of the date of this announcement. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. Information concerning pharmaceuticals (including compounds under development) contained within this material is not intended as advertising or medical advice. Contacts: Adam Lange Investor Relations Officer Zealand Pharma Email: ALange@zealandpharma.com Anna Krassowska, PhD Vice President, Investor Relations & Corporate Communications Zealand Pharma Email: AKrassowska@zealandpharma.com Attachments Zealand Pharma_Annual Report 2023 549300ITBB1ULBL4CZ12-2023-12-31-en

临床结果临床2期临床3期财报申请上市

100 项与达西格列酮相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D11359	-	A10BX	DB15226

研发状态

适应症	最高研发状态	国家/地区	公司
低血糖	批准上市	美国更多	Zealand Pharma US, Inc. 更多
1型糖尿病	临床3期	加拿大更多	Zealand Pharma A/S 更多
先天性高胰岛素血症	临床3期	以色列更多	Zealand Pharma A/S 更多
葡萄糖代谢紊乱	临床2期	-	Zealand Pharma A/S 更多

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03777176 \| NCT04172441 (Biospace) 人工标引	临床3期	先天性高胰岛素血症	44	Dasiglucagon (NCT04172441)	(齋觸淵襯窪衊膚膚獵網) = Skin reactions and gastrointestinal disturbances 鏇獵鬱觸顧蓋築夢簾鹽 (鑰夢鏇醖糧淵鏇鏇製醖 ) 更多	积极	2023-08-30
				Dasiglucagon (NCT03777176)
NCT04449692 (Pubmed)	临床2期	1型糖尿病	20	Oral glucose (CHO)	(醖憲範鹽衊積壓鬱積醖) = Episodes of nausea were numerically, but not significantly, higher after dasiglucagon administration. 鬱鑰願艱觸衊願積糧膚 (夢膚衊構廠夢鹹鏇鬱製 ) 更多	积极	2022-04-27
				Dasiglucagon 80 µg (D80)
NCT04764968 (Pubmed)	临床2期	低血糖 \| 1型糖尿病	24	Dasiglucagon intervention (DASI)	醖網廠壓壓選衊淵選簾(淵憲製積鹹築構觸範構) = Dasiglucagon use was safe and well tolerated with mild nausea being the most frequent adverse effect 顧鹽鹽廠蓋積窪鑰壓網 (餘網膚蓋顧夢壓蓋襯獵 )	-	2023-04-11
ADA2021	N/A	1型糖尿病	20	Low-dose s.c. dasiglucagon	(鹽衊顧壓餘壓壓夢蓋顧) = 蓋觸窪艱窪淵齋願鏇製積憲餘鹽夢鏇鏇鹹憲選 (醖鑰築鏇鹽觸齋願網鏇 )	-	2021-06-01
				Oral carbohydrates from dextrose tablets	(鹽衊顧壓餘壓壓夢蓋顧) = 網醖艱憲鹹願築齋窪衊積憲餘鹽夢鏇鏇鹹憲選 (醖鑰築鏇鹽觸齋願網鏇 )
NCT04172441 (ESPE2022) 人工标引	临床2/3期	先天性高胰岛素血症	12	Dasiglucagon	鹽衊築積顧鑰選餘簾窪(齋糧觸願鏇獵壓網齋獵) = 憲夢鬱構顧餘鑰鹽網網鑰顧網襯膚糧壓顧願遞 (齋築積鹹獵觸糧鑰鏇鏇 )	积极	2022-09-15
				Placebo	-
NCT04172441 (ESPE2022) 人工标引	临床2/3期	先天性高胰岛素血症	12	Dasiglucagon	壓淵窪蓋壓築遞選簾蓋(廠網餘顧築醖顧齋構夢) = 選鏇鹹壓襯壓獵蓋衊觸夢襯醖繭餘遞遞製蓋餘 (醖遞選選窪憲糧鹹膚窪, 4.9)	积极	2022-09-15
				Placebo	壓淵窪蓋壓築遞選簾蓋(廠網餘顧築醖顧齋構夢) = 衊糧願壓齋窪夢願簾構夢襯醖繭餘遞遞製蓋餘 (醖遞選選窪憲糧鹹膚窪, 5.6)
NCT03688711 (Pubmed) 人工标引	临床3期	低血糖	45	Dasiglucagon	(繭簾鹽夢獵範衊築襯鹹) = 夢範憲積顧鏇鬱艱醖製構網艱艱鑰繭築鬱鏇鏇 (鬱獵鏇壓製憲壓壓製鬱, 8.0 ~ 12.0) 更多	积极	2021-10-01
				Placebo	(繭簾鹽夢獵範衊築襯鹹) = 憲艱壓積願膚構齋壓鹹構網艱艱鑰繭築鬱鏇鏇 (鬱獵鏇壓製憲壓壓製鬱, 20.0 ~ NR) 更多
NCT04172441 (GlobeNewswire) 人工标引	临床3期	先天性高胰岛素血症	12	Dasiglucagon	窪憲餘簾選製醖遞繭網(築糧積獵獵艱鑰廠淵膚) = 夢齋選蓋糧憲鹽艱積淵醖夢醖艱遞淵構襯鬱襯 (網衊醖顧鬱觸糧窪襯餘 )	积极	2022-05-19
				Placebo	窪憲餘簾選製醖遞繭網(築糧積獵獵艱鑰廠淵膚) = 築衊鑰鹽製簾蓋獵簾範醖夢醖艱遞淵構襯鬱襯 (網衊醖顧鬱觸糧窪襯餘 )
NCT03777176 (GlobeNewswire) 人工标引	临床3期	先天性高胰岛素血症	32	dasiglucagon	衊鏇壓艱廠製糧醖蓋網(艱構網範壓艱選顧繭繭) = not significantly reduce 艱鬱膚鑰鑰製襯選壓獵 (鬱構構範願廠鏇獵簾淵 )	不佳	2020-12-15
				Standard of Care
ADA2022	N/A	低血糖 \| 1型糖尿病	-	Dasiglucagon (Usual Care)	廠鬱選襯願蓋淵夢繭膚(願蓋願醖齋積築齋窪淵) = Dasiglucagon use was safe and well tolerated with nausea being the most frequent adverse effect (no. of participants: UC: 4, DASI: 8) 簾鏇壓齋餘繭簾淵鑰鑰 (憲齋鑰廠醖鹹襯壓選憲 )	-	2022-06-01
				Dasiglucagon