NEW YORK--(BUSINESS WIRE)--Kallyope, Inc., a clinical stage biotechnology company discovering and developing novel, oral small-molecule therapeutics for diseases with high unmet need, today announced the initiation of their Phase 2 trial evaluating K-757 and K-833, new oral nutrient receptor agonists being studied for obesity and Type 2 diabetes.

纽约-（商业线）-Kallyope，Inc.，一家临床阶段生物技术公司，发现和开发用于高度未满足需求的疾病的新型口服小分子疗法，今天宣布启动评估K-757的2期临床试验和K-833，正在研究肥胖和2型糖尿病的新型口服营养受体激动剂。

The trial, K-757 P006, aims to demonstrate the weight-loss efficacy, safety, and tolerability of these novel agents for patients with obesity, a growing epidemic in the United States..

该试验K-757 P006旨在证明这些新药对肥胖患者的减肥效果，安全性和耐受性，肥胖是美国日益流行的流行病。。

Weight loss can play an important role in helping patients living with obesity to manage serious health consequences including Type 2 diabetes, cardiovascular disease, and high cholesterol. While new therapeutics are now available for the treatment of obesity and diabetes, only two percent of patients with obesity in the U.S.

减肥可以在帮助肥胖患者应对严重的健康后果方面发挥重要作用，包括2型糖尿病，心血管疾病和高胆固醇。虽然现在有新的治疗方法可用于治疗肥胖和糖尿病，但在美国只有2%的肥胖患者。

receive medical treatment.1 The availability of effective, easy to use, and well tolerated oral agents will be an important step forward in addressing this unmet need more broadly..

接受治疗.1有效，易于使用且耐受性良好的口服药物的可用性将是更广泛地解决这一未满足需求的重要一步。。

“There is a clear and present urgency for oral, easier to use, better tolerated, widely accessible, and low-cost solutions to address the enormous unmet patient need that obesity represents,” said Jay Galeota, president and CEO, Kallyope. “Today, there are many barriers to weight-loss treatment for people with obesity, including high costs, supply disruptions, issues with tolerability of present drugs, and patient and practitioner resistance to the use of injectables.

Kallyope总裁兼首席执行官Jay Galeota说：“口服，易于使用，耐受性更好，可广泛使用且成本低廉的解决方案迫切需要解决肥胖所代表的巨大未满足的患者需求。“今天，肥胖者减肥治疗存在许多障碍，包括成本高，供应中断，现有药物耐受性问题以及患者和从业者对注射剂使用的抵抗力。

It has been well demonstrated that oral treatments are highly preferred both by patients and physicians. A therapeutic with the potential to deliver meaningful weight loss and glycemic efficacy with GI tolerability, simple titration, lower cost, and improved patient access compared to many available agents will help enable the widespread treatment needed to have material impact on public health.

已经充分证明，患者和医生都非常喜欢口服治疗。与许多可用药物相比，具有GI耐受性，简单滴定，更低成本和改善患者通路的有意义的体重减轻和血糖功效的治疗剂将有助于实现对公共健康产生物质影响所需的广泛治疗。

K-757 and K-833 represent a first-in-class oral approach that may greatly enhance treatment options for people affected by obesity and Type 2 diabetes.”.

K-757和K-833代表了一流的口服方法，可以大大增强肥胖和2型糖尿病患者的治疗选择“。

“It is critical that we identify novel therapies that are safe, well tolerated, and effective for weight loss, both as stand-alone medicines and to work in combination with other drugs,” said Brett Lauring, M.D., Ph.D., Chief Medical Officer, Kallyope. “The population of people living with obesity is highly diverse and only beginning to be understood, and there is a need for multiple agents in multiple classes in order to address their different needs.”.

Kallyope首席医疗官医学博士Brett Lauring博士说：“我们必须确定安全，耐受性好，减肥有效的新疗法，既可以作为独立药物，也可以与其他药物联合使用。”。“肥胖人群高度多样化，只是开始被理解，为了满足他们的不同需求，需要多个班级的多个代理人。”。

“In a major milestone, the Kallyope team has successfully advanced these first-in-class molecules from discovery to the clinic,” said Nancy Thornberry, founding CEO and chair, Research and Development, Kallyope. “The mechanism of action for K-757 and K-833 is fundamentally different from the GLP-1 agonists now in the market.

Kallyope创始首席执行官兼研究与发展主席Nancy Thornberry说：“在一个重要的里程碑中，Kallyope团队成功地将这些一流的分子从发现提升到了临床。“K-757和K-833的作用机制与目前市场上的GLP-1激动剂有根本的不同。

Research indicates that our approach may mimic the hormone release that occurs with bariatric surgery, which many consider the gold standard for sustainable weight loss. We anticipate that this approach will be beneficial for both weight loss and glycemic control and may be easier to take and to tolerate than GLP-1s.”.

研究表明，我们的方法可能模仿减肥手术中发生的激素释放，许多人认为这是可持续减肥的黄金标准。我们预计这种方法将有利于体重减轻和血糖控制，并且可能比GLP-1更容易服用和耐受。

K-757 and K-833 are new oral nutrient receptor agonists that enhance the body’s natural metabolic signals to stimulate the secretion of multiple appetite-suppressing satiety hormones, including GLP-1, and several other well validated satiety hormones, such as PYY and CCK. This is similar to the effect on these natural appetite-suppressing hormones that is seen after bariatric surgery.

K-757和K-833是新的口服营养受体激动剂，可增强人体的天然代谢信号，刺激多种食欲抑制饱腹激素（包括GLP-1）和其他几种经过充分验证的饱腹激素（如PYY）的分泌。和CCK。这类似于减肥手术后对这些天然食欲抑制激素的作用。

They are the only known oral nutrient receptor agonists being studied for the treatment of obesity..

它们是唯一已知的用于治疗肥胖症的口服营养受体激动剂。。

About Obesity

关于肥胖

Obesity is a common, serious, and costly chronic disease of adults and children. Obesity afflicts nearly a billion people around the world and is linked to between 3 and 5 million deaths per year. Traditionally, obesity has been treated with diet and exercise and, more recently, surgery and drugs, yet the global prevalence of obesity has increased markedly in recent decades.

肥胖是成人和儿童常见的，严重的和昂贵的慢性疾病。肥胖折磨着全世界近10亿人，每年导致300万至500万人死亡。传统上，肥胖已经通过饮食和运动以及最近的手术和药物进行治疗，但近几十年来全球肥胖患病率显着增加。

It is estimated that 42.5 percent of adults in the United States – more than 100 million people – are living with obesity,2 and more than 35 million adults live with Type 2 diabetes.3 The NIH projects that the number of U.S adults with Type 2 diabetes will skyrocket to nearly 55 million by 2030,4 and it is estimated that nearly half of U.S.

据估计，美国42.5%的成年人-超过1亿人-患有肥胖症，2超过3500万成年人患有2型糖尿病.3美国国立卫生研究院预测，美国成年人的数量到2030年，2型糖尿病将飙升至近5500万，据估计，近一半的美国。

adults will be obese.5.

成年人会肥胖。

About Kallyope

关于Kallyope

Kallyope, a clinical stage biotechnology company, is leveraging its proprietary Klarity™ therapeutic platform to discover and develop novel, oral small-molecule therapeutics in areas with high unmet medical need, including diabetes and obesity, gastrointestinal disease, and neurological disorders.

临床阶段生物技术公司Kallyope正在利用其专有的Klarity™ 在糖尿病和肥胖症，胃肠疾病和神经系统疾病等高度未满足医疗需求的领域发现和开发新型口服小分子疗法的治疗平台。

_______________________

_______________________

1 Unique non-diabetes patients via Trilliant Health Analysis, via STAT and American Society for Metabolic and Bariatric Surgery

1独特的非糖尿病患者通过Trilliant健康分析，通过STAT和美国代谢和减肥手术学会

2 Prevalence of Overweight, Obesity, and Severe Obesity Among Adults Aged 20 and Over: United States, 1960–1962 Through 2017–2018 https://www.cdc.gov/nchs/data/hestat/obesity-adult-17-18/overweight-obesity-adults-H.pdf

2 20岁及以上成年人超重，肥胖和严重肥胖的患病率：美国，1960-1962年至2017-2018年https://www.cdc.gov/nchs/data/hestat/obesity-adult-17-18/overweight-obesity-adults-H.pdf

3 Centers for Disease Control and Prevention. National Diabetes Statistics Report website https://www.cdc.gov/diabetes/data/statistics-report/index.html

3疾病预防控制中心。国家糖尿病统计报告网站https://www.cdc.gov/diabetes/data/statistics-report/index.html

4 Diabetes 2030: Insights from Yesterday, Today, and Future Trends https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5278808/

4糖尿病2030：昨天，今天和未来趋势的见解https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5278808/

5 Projected U.S. State-Level Prevalence of Adult Obesity and Severe Obesity https://www.nejm.org/doi/full/10.1056/NEJMsa1909301

5预计美国各州成人肥胖和严重肥胖的患病率https://www.nejm.org/doi/full/10.1056/NEJMsa1909301