Study participants receiving 0.6 and 1.2 mg ecnoglutide once weekly for 24 weeks achieved HbA1c reductions of 1.96 and 2.43% from baseline, respectively, compared to 0.87 % for placebo

研究参与者每周接受一次0.6和1.2 mg依诺鲁肽治疗24周，HbA1c分别比基线降低1.96和2.43%，而安慰剂组为0.87%

In the 1.2 mg ecnoglutide cohort, 76.1% of participants achieved HbA1c ≤ 6.5% and 35.2% achieved HbA1c < 5.7% at the end of the 24-week treatment

在1.2 mg依诺鲁肽队列中，76.1%的参与者在24周治疗结束时达到HbA1c≤6.5%，35.2%的参与者达到HbA1c<5.7%

Ecnoglutide was safe and well tolerated with gastrointestinal side effects as the most commonly reported adverse events

埃诺鲁肽安全且耐受性良好，胃肠道副作用是最常报告的不良事件

HANGZHOU, China and SAN FRANCISCO, Jan. 2, 2024 /PRNewswire/ -- Sciwind Biosciences Co., Ltd., a clinical-stage biopharmaceutical company focused on discovering and developing innovative therapies to treat metabolic diseases, today announced positive topline results from a Phase 3 clinical trial of ecnoglutide (XW003) in Chinese adults with type 2 diabetes mellitus (T2DM).

中国杭州和旧金山，2024年1月2日/PRNewswire/--Sciwind Biosciences Co.，Ltd.，一家专注于发现和开发治疗代谢性疾病的创新疗法的临床阶段生物制药公司，今天宣布了在中国2型糖尿病（T2DM）成年人中进行的艾诺鲁肽（XW003）3期临床试验的阳性结果。

Ecnoglutide is a long-acting, cAMP signaling biased, glucagon-like peptide-1 (GLP-1) analog that is being developed for the treatment of type 2 diabetes and obesity..

Ecnoglutide是一种长效，cAMP信号偏向的胰高血糖素样肽-1（GLP-1）类似物，正在开发用于治疗2型糖尿病和肥胖症。。

The Phase 3 trial (NCT05680155) is a randomized, double-blind, placebo-controlled study that enrolled 211 participants at 33 sites in China. Eligible subjects had T2DM that was inadequately controlled by diet and exercise. Participants were randomized to receive ecnoglutide (0.6 mg or 1.2 mg) or placebo as once weekly injections for 24 weeks, including a dose escalation period.

第三阶段试验（NCT05680155）是一项随机，双盲，安慰剂对照研究，在中国33个地点招募了211名参与者。符合条件的受试者患有T2DM，其饮食和运动控制不足。参与者被随机分配接受埃诺鲁肽（0.6 mg或1.2 mg）或安慰剂，每周注射一次，持续24周，包括剂量递增期。

Analysis was conducted at week 24 to allow comparison of ecnoglutide with placebo. All participants were then eligible to receive open label ecnoglutide at target doses of 0.6 or 1.2 mg for a total treatment duration of 52 weeks. Changes in mean HbA1c, body weight and BMI, as well as safety and tolerability were evaluated.

在第24周进行分析，以比较埃诺鲁肽与安慰剂。然后，所有参与者都有资格接受开放标签的依那鲁肽，目标剂量为0.6或1.2 mg，总治疗时间为52周。评估平均HbA1c，体重和BMI的变化，以及安全性和耐受性。

At baseline, participants had a mean HbA1c of 8.5% and mean body weight of 73 kilograms..

在基线时，参与者的平均HbA1c为8.5%，平均体重为73公斤。。

After 24 weeks of treatment, participants receiving ecnoglutide achieved statistically significant reductions in HbA1c. The majority of the participants receiving ecnoglutide achieved HbA1c of less than 7% (the American Diabetes Association's recommended target for people with diabetes) and a significant proportion achieved HbA1c of less than 5.7%.

治疗24周后，接受埃诺鲁肽治疗的参与者在HbA1c方面取得了统计学上的显着降低。接受埃诺鲁肽治疗的大多数参与者的HbA1c低于7%（美国糖尿病协会推荐的糖尿病患者目标），相当一部分参与者的HbA1c低于5.7%。

There were also significant body weight decreases for participants receiving ecnoglutide. Key topline efficacy results of the study are summarized in the table below..

接受埃诺鲁肽治疗的参与者体重也显着下降。下表总结了该研究的关键终点疗效结果。。

Summary of Efficacy Results

疗效结果总结

Week 24

第24周

Placebo (N=71)

安慰剂（N=71）

0.6 mg ecnoglutide (N=69)

0.6 mg艾诺鲁肽（N=69）

1.2 mg ecnoglutide (N=71)

1.2 mg艾诺鲁肽（N=71）

HbA1c change from baseline

HbA1c与基线的变化

-0.87 %

-0.87 %

-1.96% (P=0.0003)

-1.96%（P=0.0003）

-2.43% (P<0.0001)

-2.43%（P<0.0001）

Percent of participants achieving HbA1c < 7%

HbA1c<7%的参与者百分比

21.1 %

21.1 %

68.1 %

68.1 %

80.3 %

80.3 %

Percent of participants achieving HbA1c ≤ 6.5%

达到HbA1c的参与者百分比≤6.5%

12.7 %

12.7 %

52.2 %

52.2 %

76.1 %

76.1 %

Percent of participants achieving HbA1c < 5.7%

HbA1c<5.7%的参与者百分比

0 %

0 %

10.1 %

10.1 %

35.2 %

35.2 %

Percent body weight change from baseline

与基线相比体重变化百分比

-2.02 %

-2.02 %

-4.51% (P=0.0002)

-4.51%（P=0.0002）

-4.74% (P<0.0001)

-4.74%（P<0.0001）

Overall safety and tolerability of ecnoglutide in this study was consistent with the established profile of GLP-1 receptor agonists. The most frequently reported adverse events included decreased appetite, diarrhea, and nausea, and majority of the AEs were mild to moderate in severity. A total of three subjects, one (1.4%) from each cohort, discontinued the study due to adverse events..

本研究中埃诺鲁肽的总体安全性和耐受性与GLP-1受体激动剂的既定特征一致。最常报告的不良事件包括食欲下降，腹泻和恶心，大多数不良事件的严重程度为轻度至中度。由于不良事件，共有三名受试者（每个队列中有一名（1.4%）停止了研究。。

'We are very pleased to see the positive results from the first Phase 3 clinical trial of ecnoglutide in China. The HbA1c reductions observed after 24 weeks of treatment are very promising and are comparable to the treatment effects seen with dual GLP-1/GIP analogs such as tirzepatide,' said Hai Pan, CEO of Sciwind Biosciences.

“我们很高兴看到埃诺鲁肽在中国的第一个3期临床试验取得了积极的结果。Sciwind Biosciences首席执行官海潘（Hai Pan）说，治疗24周后观察到的HbA1c降低非常有希望，与双重GLP-1/GIP类似物（如tirzepatide）的治疗效果相当。

'The strong efficacy we are seeing with ecnoglutide in clinical studies is consistent with its cAMP signaling biased mechanism of action.'.

“我们在临床研究中看到的埃诺鲁肽的强大功效与其cAMP信号偏向的作用机制一致。”。

In addition to this Phase 3 trial in T2DM patients, which is expected to complete in the first half of 2024, ecnoglutide is also being evaluated in two additional Phase 3 trials. These fully enrolled trials are investigating ecnoglutide versus dulaglutide in T2DM (NCT05680129) and ecnoglutide versus placebo in participants with overweight or obesity (NCT05813795).

除了这项针对T2DM患者的3期临床试验（预计将于2024年上半年完成）外，埃诺鲁肽还将在另外两项3期临床试验中进行评估。这些完全登记的试验正在研究超重或肥胖参与者（NCT05813795）中的依那鲁肽与杜拉鲁肽在T2DM中的作用（NCT05680129）和依那鲁肽与安慰剂的作用。

Results from both pivotal studies are expected in the second half of 2024..

这两项关键研究的结果预计将在2024年下半年公布。。

About ecnoglutide (XW003)

关于艾诺鲁肽（XW003）

Glucagon-like peptide-1 (GLP-1) analogs are effective therapies in managing type 2 diabetes, obesity, and have demonstrated clinical potential as a treatment for NASH. Ecnoglutide (XW003) is a novel, cAMP signaling biased, long-acting GLP-1 analogue optimized for improved biological activity, cost-effective manufacturing, and once weekly dosing.

胰高血糖素样肽-1（GLP-1）类似物是治疗2型糖尿病，肥胖的有效疗法，并且已经证明了作为NASH治疗的临床潜力。Ecnoglutide（XW003）是一种新型的，cAMP信号偏向的长效GLP-1类似物，经过优化，可改善生物活性，具有成本效益的制造和每周一次的给药。

XW003 has demonstrated treatment benefits for patients with type 2 diabetes and obesity and is safe and well tolerated in completed clinical studies..

XW003已证明对2型糖尿病和肥胖症患者有治疗益处，并且在完成的临床研究中安全且耐受性良好。。

About Sciwind

关于Sciwind

Sciwind Biosciences is a clinical stage biopharmaceutical company focusing on discovering and developing innovative therapies to treat metabolic disease. Its product pipeline consists of potentially first-in-class and best-in-class drug candidates, including the long-acting GLP-1 peptide analog ecnoglutide (Phase 3), oral GLP-1 peptide analog XW004 (Phase 1), and oral small molecule GLP-1 receptor agonist XW014 (Phase 1).

Sciwind Biosciences是一家临床阶段的生物制药公司，专注于发现和开发治疗代谢性疾病的创新疗法。其产品线由潜在的一流和一流的候选药物组成，包括长效GLP-1肽类似物埃诺鲁肽（第3阶段），口服GLP-1肽类似物XW004（第1阶段）和口服小分子GLP-1受体激动剂XW014（第1阶段）。

Sciwind has developed multiple proprietary technologies, including oral peptide and inhaled protein therapeutic delivery platforms and identified a series of drug candidates based on these core platform technologies. For more information, visit www.sciwindbio.com..

Sciwind开发了多种专有技术，包括口服肽和吸入蛋白质治疗递送平台，并基于这些核心平台技术确定了一系列候选药物。有关更多信息，请访问www.sciwindbio.com。。

SOURCE Hang Zhou Sciwind Biosciences Co., Ltd.

来源杭州西风生物科技有限公司。