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

口服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

Study participants receiving up to 30 mg oral ecnoglutide once-daily for 6 weeks achieved a mean body weight reduction of -6.8% from baseline, compared to -0.9% for the placebo group

研究参与者每天一次服用高达30毫克的口服依诺鲁肽，持续6周，与安慰剂组相比，平均体重减轻了6.8%，而安慰剂组为0.9%

The study remains ongoing to evaluate additional dosing regimens including once-weekly oral administration

该研究仍在进行中，以评估其他给药方案，包括每周一次口服给药

HANGZHOU, China and SAN FRANCISCO , Jan. 23, 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 interim results from the first four cohorts of a Phase 1 clinical trial of oral ecnoglutide (XW004).

中国杭州和旧金山，2024年1月23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，今天宣布了口服依诺鲁肽（XW004）1期临床试验前四个队列的积极中期结果。

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. XW004 is an oral tablet formulation of ecnoglutide..

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。XW004是依诺鲁肽的口服片剂制剂。。

The Phase 1 trial (NCT05184322) is a randomized, double-blind, placebo-controlled multiple ascending dose study that enrolled 42 healthy (Cohorts 1-3) and 14 healthy obese (Cohort 4) participants in Australia. Participants were randomized to receive placebo or XW004 as once-daily oral tablets. In Cohorts 1-3, target doses were 7 mg, 15 mg, or 30 mg XW004 once-daily for 2 weeks; in Cohort 4 the target dose was 30 mg XW004 once-daily for 6 weeks.

第一阶段试验（NCT05184322）是一项随机，双盲，安慰剂对照的多剂量递增研究，在澳大利亚招募了42名健康（队列1-3）和14名健康肥胖（队列4）参与者。参与者被随机分配接受安慰剂或XW004作为每日一次的口服片剂。在队列1-3中，目标剂量为7 mg，15 mg或30 mg XW004，每天一次，持续2周；在队列4中，目标剂量为30 mg XW004，每天一次，持续6周。

Treatment periods included gradual dose escalation to the target doses. Safety, tolerability, pharmacokinetics and changes in mean body weight from baseline were evaluated..

治疗期间包括逐渐增加剂量至目标剂量。评估了安全性，耐受性，药代动力学和平均体重相对于基线的变化。。

Overall safety and tolerability of oral ecnoglutide were consistent with the established profile of GLP-1 peptide agonists. The most frequently reported adverse events included nausea, headache, diarrhea, vomiting, and decreased appetite. The majority of adverse events were mild to moderate in severity and occurred mostly during the dose-escalation periods..

口服埃诺鲁肽的总体安全性和耐受性与GLP-1肽激动剂的既定特征一致。最常报告的不良事件包括恶心，头痛，腹泻，呕吐和食欲下降。大多数不良事件的严重程度为轻度至中度，主要发生在剂量递增期间。。

At baseline, participants had a mean body weight of 75.6 to 77.9 kilograms for Cohorts 1-3 and 100.1 kilograms for Cohort 4. Mean BMI at baseline was 25.8 to 26.1 kg/m² for Cohorts 1-3 and 32.9 kg/m² for Cohort 4. In Cohorts 1-3, treatment with doses up to 7, 15, or 30 mg XW004 once-daily for 2 weeks resulted in body weight changes of -3.6%, -3.4%, and -6.6%, respectively, compared to -0.9% for the placebo group.

在基线时，第1-3组参与者的平均体重为75.6至77.9公斤，第4组为100.1公斤。第1-3组的基线平均BMI为25.8至26.1 kg/m²，第4组为32.9 kg/m²。在队列1-3中，每天一次剂量高达7,15或30 mg XW004治疗2周，体重变化分别为-3.6%，-3.4%和-6.6%，而安慰剂组为-0.9%。

In obese participants (Cohort 4), treatment with doses up to 30 mg XW004 once-daily for 6 weeks resulted in -6.8% body weight loss at end of treatment, compared to -0.9% for the placebo group. In addition, pharmacokinetics of XW004 showed good absorption after oral administration..

在肥胖参与者（队列4）中，每天一次高达30 mg XW004的剂量治疗6周，治疗结束时体重减轻了-6.8%，而安慰剂组为-0.9%。此外，口服给药后，XW004的药代动力学表现出良好的吸收。。

Table. Summary of mean body weight changes from baseline in Cohorts 1-4

表。队列1-4中平均体重从基线变化的总结

Study Cohort

研究队列

XW004 dosing schedule (once daily)

XW004给药时间表（每天一次）

Body weight change from baseline (%)

体重与基线的变化（%）

Week 2

第2周

Week 6

第6周

Placebo (N=8)

安慰剂（N=8）

N/A

药方药方

-0.9 %

-0.9 %

-0.9 %

-0.9 %

Cohort 1 (N=10)

队列1（N=10）

2mg (day 1-5) -> 7mg (day 6-15)

2mg（第1-5天）->7mg（第6-15天）

-3.6 %

-3.6 %

N/A

药方药方

Cohort 2 (N=10)

队列2（N=10）

2mg (day 1-5) -> 7mg (day 6-10) -> 15mg (day 11-15)

2 mg（第1-5天）->7 mg（第6-10天）->15 mg（第11-15天）

-3.4 %

-3.4 %

N/A

药方药方

Cohort 3 (N=11)

队列3（N=11）

7mg (day 1-5) -> 15mg (day 6-10) -> 30mg (day 11-15)

7mg（第1-5天）->15mg（第6-10天）->30mg（第11-15天）

-6.6 %

-6.6 %

N/A

药方药方

Cohort 4 (N=11)

队列4（N=11）

2mg (day 1-5) -> 7mg (day 6-10) -> 15mg (day 11-15) -> 30mg (day 16-44)

2 mg（第1-5天）->7 mg（第6-10天）->15 mg（第11-15天）->30 mg（第16-44天）

-2.5 %

-2.5 %

-6.8 %

-6.8 %

'We are very encouraged by the favorable safety, efficacy, and pharmacokinetic profile of XW004 observed in this study. The strong body weight loss results after short-term administration support the development of oral ecnoglutide for the treatment of obesity and type 2 diabetes' said Hai Pan, founder and CEO of Sciwind Biosciences..

“我们对本研究中观察到的XW004的良好安全性，有效性和药代动力学特征感到非常鼓舞。Sciwind Biosciences创始人兼首席执行官海潘（Hai Pan）说，短期服用后体重减轻的结果支持了口服依诺鲁肽治疗肥胖症和2型糖尿病的发展。。

Based on the results of Cohorts 1-4, the study is continuing and will evaluate additional dosing regimens, including once-weekly oral administration of XW004 in participants with obesity. 'We believe that less frequent dosing regimens can significantly improve patient compliance, overcome manufacturing challenges, and greatly increase access to this drug class for broad patient populations,' said Mohammed Junaidi, MD, Sciwind Vice President of Clinical Development.

根据队列1-4的结果，该研究正在继续进行，并将评估其他给药方案，包括肥胖参与者每周一次口服XW004。Sciwind临床开发副总裁穆罕默德·朱奈迪（MohammedJunaidi）医学博士说：“我们认为，频率较低的给药方案可以显着提高患者的依从性，克服制造挑战，并大大增加广大患者人群获得该类药物的机会。”。

'If successfully developed, XW004 has the potential to become the first once-weekly oral GLP-1 receptor agonist for the treatment of metabolic conditions.'.

“如果成功开发，XW004有可能成为第一种每周一次的口服GLP-1受体激动剂，用于治疗代谢疾病。”。

About ecnoglutide (XW003 and XW004)

关于ecnoglutide（XW003和XW004）

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 clinical studies. XW004 is an oral tablet formulation of ecnoglutide..

XW003已证明对2型糖尿病和肥胖症患者有治疗益处，在临床研究中安全且耐受性良好。XW004是依诺鲁肽的口服片剂制剂。。

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 ecnoglutide tablet 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），口服埃诺鲁肽片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。