AT278demonstrates significantlyacceleratedPK/PD profilecomparedtoNovoRapid® and Humulin® R U-500 in people with Type 2 Diabetes and high BMI

AT278在2型糖尿病和高BMI患者中显示出与vorapid®和Humulin®R U-500相比显着加速的PK/PD谱

Confirms previous trial results in people with Type 1 diabetes, demonstrating AT278 can maintain fast and superior onset of action and glucose lowering profile irrespective of diabetes type and BMI

证实了先前对1型糖尿病患者的试验结果，证明AT278可以保持快速而优越的起效和降糖效果，而与糖尿病类型和BMI无关

Enables delivery of a highly concentrated, low volume injection, offering more effective mealtime glucose control to meet growing unmet need in patients requiring high daily doses of insulin

能够提供高浓度、低容量的注射，提供更有效的进餐时间血糖控制，以满足需要每日高剂量胰岛素的患者日益增长的未满足需求

Creates potentialtobe thefirst, and only, ultra-concentrated(500 U/mL)ultra-rapid insulinproductenabling miniaturisation of next-generation insulin pumps

创造潜力成为第一个也是唯一一个超浓缩（500 U/mL）超快速胰岛素产品，使下一代胰岛素泵小型化

Company will host a CEO and key opinion leader webinar to discuss the results on Tuesday 21 May at 14.30 BST

该公司将于5月21日（星期二）英国夏令时14:30举办首席执行官和关键意见领袖网络研讨会，讨论结果

Cambridge, UK, 20 May 2024. Arecor Therapeutics plc (AIM: AREC), the biopharmaceutical group advancing today’s therapies to enable healthier lives, today announces that its ultra-concentrated, ultra-rapid acting insulin candidate, AT278, met all primary and secondary endpoints, and also demonstrated superiority to NovoRapid® and Humulin® R U-500, in a Phase I clinical trial in Type 2 diabetics with a high body mass index (BMI)..

英国剑桥，2024年5月20日。生物制药集团Arecor Therapeutics plc（目标：AREC）今天宣布，其超浓缩，超快速作用的胰岛素候选物AT278符合所有主要和次要终点，并且在高体重指数（BMI）的2型糖尿病患者的I期临床试验中显示出优于NovoRapid®和Humulin®R U-500的优势。。

AT278 (500 U/mL) is an ultra-concentrated, ultra-rapid acting, novel formulation of insulin that accelerates the absorption of insulin post injection, even when delivered at a high concentration, and hence a lower injection volume. With no concentrated (>200 U/mL), rapid acting insulins on the market, AT278 has potential to be the first, and only, insulin available to the growing number of patients with high daily insulin requirements..

AT278（500 U/mL）是一种超浓缩，超快速作用的新型胰岛素制剂，即使以高浓度递送，也能加速注射后胰岛素的吸收，从而降低注射量。由于市场上没有浓缩（>200 U/mL）的速效胰岛素，AT278有可能成为第一个也是唯一一个可供越来越多每日胰岛素需求高的患者使用的胰岛素。。

SarahHowell,ChiefExecutiveOfficerofArecor,said:'We are delighted with the clinical results from this second Phase I study, demonstrating AT278’s superiority over NovoRapid® and Humulin® R U-500 in Type 2 diabetics with a high BMI. They further add to the positive results from our previous clinical study in Type 1 diabetic patients, where superiority was also demonstrated.

SarahHowell，ChiefExecutiveOfficerofArecor说：“我们对第二阶段I研究的临床结果感到高兴，证明AT278在高BMI的2型糖尿病患者中优于NovoRapid®和Humulin®R U-500。他们进一步增加了我们之前在1型糖尿病患者中进行的临床研究的积极结果，也证明了其优越性。

This is a significant step in AT278’s development and extends our confidence in its clear potential to provide a superior insulin treatment option that lowers burden and improves outcomes for people living with diabetes who require high daily doses of insulin. Such patients make up a large segment of the target market.

这是AT278发展的重要一步，并扩大了我们对其提供优越胰岛素治疗选择的明确潜力的信心，该选择可以减轻每日需要高剂量胰岛素的糖尿病患者的负担并改善其预后。此类患者占目标市场的很大一部分。

In addition, as the only concentrated, yet very rapid acting, insulin in development, AT278 has the capability to disrupt the market by enabling the next generation of truly miniaturised, longer-wear insulin pumps, a key focus for patients, physicians and the industry.”.

此外，AT278作为开发中唯一一种集中但作用非常迅速的胰岛素，它能够通过实现下一代真正小型化，耐磨性更长的胰岛素泵来扰乱市场，这是患者，医生和行业的关键焦点。”。

Many Type 2 diabetics with a high BMI are currently not well controlled, and improved treatments options such as AT278 are needed to reduce patient burden through fewer injections per day, reduced injection volumes and dosing flexibility around mealtimes. This lowering of burden for patients improves treatment adherence and, allied with AT278’s superior efficacy, should improve both blood glucose control and outcomes.

许多BMI高的2型糖尿病患者目前没有得到很好的控制，需要改进的治疗方案，如AT278，通过每天减少注射，减少注射量和用餐时间的剂量灵活性来减轻患者负担。这种减轻患者负担的方法可以提高治疗依从性，再加上AT278的优越疗效，应该可以改善血糖控制和预后。

In addition, a truly ultra-rapid, ultra-concentrated insulin is a critical step towards next-generation miniaturised and long-wearing insulin pumps, which are predicted to transform future diabetes management..

此外，真正超快速、超浓缩的胰岛素是迈向下一代微型长效胰岛素泵的关键一步，预计将改变未来的糖尿病管理。。

Professor Thomas Pieber, Principal Investigator for the ARE-278-104 clinical trial, said: “These results are highly significant, AT278 has clearly demonstratedfasterinsulinabsorptionwithanacceleratedPharmacokinetic(PK)andPharmacodynamic(PD) profile compared to the lower concentration standard insulin aspart (NovoRapid®).

ARE-278-104临床试验的首席研究员托马斯·皮伯教授说：“这些结果非常重要，与低浓度标准门冬胰岛素（NovoRapid®）相比，AT278已经清楚地证明了胰岛素的快速吸收，具有加速的药代动力学（PK）和药效学（PD）特征。

The PK/PD profile of AT278 (500 U/mL) was also greatly accelerated compared to Humulin®R U-500 (500 U/mL). Together with its superior profile in the earlier Phase I clinical study in Type 1 diabetic patients1AT278 has demonstrated its ability to maintain a fast and superior onset of action and glucose lowering profile irrespective of diabetes type and BMI.

与Humulin®R U-500（500 U/mL）相比，AT278（500 U/mL）的PK/PD曲线也大大加速。加上其在1型糖尿病患者早期I期临床研究中的优越性1at278已证明其能够保持快速且优越的起效和降糖特征，而与糖尿病类型和BMI无关。

This makes AT278 completely unique in the competitive field of insulin analogues. Not only does it have the potential to significantly improve post-prandial glucose control whilst lowering burden for anybody with diabetes who has a high daily insulin need, it can act as a catalyst in the development of miniaturised insulin delivery systems, where the size of existing devices is a significant barrier to use for many patients.”.

这使得AT278在胰岛素类似物的竞争领域完全独特。它不仅有可能显着改善餐后血糖控制，同时降低每日胰岛素需求高的任何糖尿病患者的负担，它还可以作为微型胰岛素输送系统开发的催化剂，现有设备的大小是许多患者使用的重要障碍。”。

In the double-blind, randomised, two-way crossover study, the pharmacokinetic (PK)/pharmacodynamic (PD) and safety profiles of a single subcutaneous (SC) dose of 0.5 U/kg AT278 (500 U/mL) were compared with those of a single SC dose of 0.5 U/kg NovoRapid® (100 U/mL), a currently available gold standard, rapid acting insulin treatment, in 39 participants with Type 2 diabetes within a BMI range of 25 and 39 kg/m2, in a euglycemic clamp setting.

在双盲，随机，双向交叉研究中，将单次皮下（SC）剂量为0.5 U/kg AT278（500 U/mL）的药代动力学（PK）/药效学（PD）和安全性与单次SC剂量为0.5 U/kg NovoRapid®（100 U/mL）（目前可用的金标准速效胰岛素治疗）的药代动力学（PK）/药效学（PD）和安全性进行比较，在正常血糖钳夹设置下，39名BMI范围为25和39 kg/m2的2型糖尿病患者。

The PK/PD profile of 0.5 U/kg AT278 (500 U/mL) was also compared to a single SC dose of 0.5U/kg Humulin® R U-500 (500 U/mL) in an open label manner..

还以开放标签方式将0.5 U/kg AT278（500 U/mL）的PK/PD曲线与0.5U/kg Humulin®R U-500（500 U/mL）的单次SC剂量进行了比较。。

The trial met the primary endpoint of non-inferiority with respect to glucose lowering actions compared with NovoRapid®

与NovoRapid®相比，该试验在降糖作用方面达到了非劣效性的主要终点

AT278 (500 U/mL) demonstrated a significantly accelerated (superior) early PK/PD profile compared to NovoRapid® (100 U/mL), despite a 5-fold increase in concentration

尽管浓度增加了5倍，但与NovoRapid®（100 U/mL）相比，AT278（500 U/mL）显示出明显加速（优越）的早期PK/PD曲线

AT278 (500 U/mL) demonstrated a significantly accelerated (superior) PK/PD profile compared to Humulin® R U-500 (500 U/mL), the only other insulin available at a concentration of 500 U/mL

与Humulin®R U-500（500 U/mL）相比，AT278（500 U/mL）表现出显着加速（优越）的PK/PD曲线，Humulin®R U-500是唯一可用的其他胰岛素，浓度为500 U/mL

No safety signals were detected

未检测到安全信号

With around 537m people living with diabetes worldwide, there are growing numbers of people who require insulin to manage their blood glucose and, for many, their diabetes is still poorly controlled. There is a growing need for highly concentrated, much faster, and more physiological insulins to effectively manage diabetes.

全世界约有5.37亿人患有糖尿病，越来越多的人需要胰岛素来控制血糖，对许多人来说，他们的糖尿病仍然控制不佳。人们越来越需要高浓度，更快，更多的生理胰岛素来有效控制糖尿病。

In the US alone, nearly 10% of insulin scripts written in 2022 were for products with a concentration of >100 U/mL2. Furthermore, despite the improvements in outcomes among people with diabetes who use insulin pumps and automated delivery systems, they are still only used by less than 40% of people with Type 1 diabetes and less than 10% of people with Type 2 diabetes in the US3.

仅在美国，2022年编写的胰岛素脚本中就有近10%用于浓度>100 U/mL2的产品。此外，尽管使用胰岛素泵和自动输送系统的糖尿病患者的结局有所改善，但在美国，只有不到40%的1型糖尿病患者和不到10%的2型糖尿病患者使用胰岛素泵和自动输送系统3。

The size and short duration of wear of existing insulin pumps remains a significant barrier to use. AT278 has the potential to be the only highly concentrated, ultra-rapid acting insulin to enable the next generation of miniaturised, longer wear insulin pumps. The insulin pump market is valued at circa $5.5bn market today4, with a significant opportunity for substantial growth in this market by expanding use across the Type 1 and Type 2 patient population that can be further enabled by AT278 and a next generation insulin pump..

现有胰岛素泵的尺寸和磨损时间短仍然是使用的重大障碍。AT278有可能成为唯一一种高浓度，超快速作用的胰岛素，以实现下一代微型，长效胰岛素泵。今天，胰岛素泵市场价值约为55亿美元4，通过在1型和2型患者人群中扩大使用，可以通过AT278和下一代胰岛素泵进一步实现，这是该市场大幅增长的重要机会。。

A full analysis of the trial data is now underway to enable the Company to determine and pursue a strategy for AT278 that maximises value for shareholders and patients. Detailed data from the trial will be submitted for publication and presentation at a future international diabetes conference.

目前正在对试验数据进行全面分析，以使该公司能够确定并实施AT278战略，最大限度地为股东和患者创造价值。该试验的详细数据将提交给未来的国际糖尿病会议发表和介绍。

AT278 clinical results CEO and KOL webinar - Tuesday 21 May

AT278临床结果首席执行官和KOL网络研讨会-5月21日星期二

Dr Sarah Howell, Chief Executive Officer, and Professor Thomas Pieber, Principal Investigator for the ARE-278-104 clinical trial and Professor of Medicine, Head of the Division of Endocrinology and Metabolism and Chairman of the Department of Internal Medicine at Medical University of Graz, Austria will host a CEO and key opinion leader webinar to discuss the clinical results on Tuesday 21 May at 14.30 BST..

首席执行官莎拉·豪厄尔博士和ARE-278-104临床试验首席研究员、医学教授、内分泌与代谢科科长、奥地利格拉茨医科大学内科系主任托马斯·皮伯教授将于5月21日星期二英国夏令时14时30分主持一场CEO兼关键意见领袖网络研讨会，讨论临床结果。。

To register to join the live webcast click here and to register for the conference line to ask questions click here.

要注册以加入直播网络广播，请单击此处；要注册会议热线以提问，请单击此处。

Please contact ICR Consilium for details on arecor@consilium-comms.com.

有关详细信息，请联系ICR Consiliumarecor@consilium-comms.com.

This announcement contains inside information for the purposes of the retained UK version of the EU Market Abuse Regulation (EU) 596/2014 ('UK MAR').

本公告包含欧盟市场滥用法规（EU）596/2014（“英国MAR”）保留英国版本的内部信息。

-ENDS-

-结束-

References

参考文献

Pharmacokinetics and Pharmacodynamics of a Novel U500 Insulin Aspart Formulation: A Randomized, Double-Blind, Crossover Study in People With Type 1 Diabetes Care 2023;46(4):757–764: https://doi.org/10.2337/dc22-1054

新型U500门冬胰岛素制剂的药代动力学和药效学：2023年1型糖尿病患者的随机，双盲，交叉研究；46（4）：757–764：https://doi.org/10.2337/dc22-1054

2022 reports from Symphony. Retrieved October 2023

2022年交响乐团报道。2023年10月检索

Seagrove Partners Diabetes Bluebook 2022

Seagrove Partners糖尿病蓝皮书2022

Insulin pump company annual reports and Company estimates

胰岛素泵公司年度报告和公司估计

For more information, please contact:

有关更多信息，请联系：

Arecor Therapeutics plc

Arecor Therapeutics plc公司

www.arecor.com

www.arecor.com

Dr Sarah Howell, Chief Executive Officer

首席执行官Sarah Howell博士

Tel: +44 (0) 1223 426060

电话：+44（0）1223 426060

Email: info@arecor.com

电子邮件info@arecor.com

Susan Lowther, Chief Financial Officer

首席财务官苏珊·洛瑟

Tel: +44 (0) 1223 426060

电话：+44（0）1223 426060

Email: info@arecor.com

电子邮件info@arecor.com

Panmure Gordon (UK) Limited (NOMAD and Broker)

Panmure Gordon（英国）有限公司（NOMAD and Broker）

Freddy Crossley, Emma Earl (Corporate Finance)

Freddy Crossley，Emma Earl（公司财务）

Rupert Dearden (Corporate Broking)

鲁珀特·迪尔登（企业经纪）

Tel: +44 (0) 20 7886 2500

电话：+44（0）20 7886 2500

WG Partners LLP (Financial Advisor)

WG Partners LLP（财务顾问）

Nigel Barnes, Satheesh Nadarajah

Nigel Barnes，Satheesh Nadrajah

David Wilson, Claes Spang

大卫·威尔逊，克莱斯·斯潘

Tel: +44 (0)203 705 9321

电话：+44（0）203 705 9321

ICR Consilium

ICR Consilium

Chris Gardner, David Daley, Lindsey Neville

Chris Gardner、David Daley、Lindsey Neville

Tel: +44 (0) 20 3709 5700

电话：+44（0）20 3709 5700

Email: arecor@consilium-comms.com

电子邮件arecor@consilium-comms.com

Notes to Editors

编辑注释

About Arecor

关于Arecor

Arecor Therapeutics plc is a globally focused biopharmaceutical company transforming patient care by bringing innovative medicines to market through the enhancement of existing therapeutic products. By applying our innovative proprietary technology platform, Arestat™, we are developing an internal portfolio of proprietary products in diabetes and other indications, as well as working with leading pharmaceutical and biotechnology companies to deliver therapeutic products.

Arecor Therapeutics plc是一家专注于全球的生物制药公司，通过增强现有治疗产品将创新药物推向市场，从而改变患者护理。通过应用我们创新的专有技术平台Arestat™，我们正在开发糖尿病和其他适应症专有产品的内部组合，并与领先的制药和生物技术公司合作提供治疗产品。

The Arestat™ platform is supported by an extensive patent portfolio..

Arestat™平台由广泛的专利组合支持。。

For further details please see our website, www.arecor.com

有关更多详细信息，请访问我们的网站www.arecor.com