Kallyope Enters Phase 2 With First-in-class Oral Approach for the Treatment of Both Obesity and Type 2 Diabetes
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.
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. 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.
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. 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.
“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. 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. 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.”
“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.”
“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. 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.”
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. They are the only known oral nutrient receptor agonists being studied for the treatment of obesity.
About Obesity
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. 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. adults will be obese.5
About 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.
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1 Unique non-diabetes patients via Trilliant Health Analysis, via STAT and American Society for Metabolic and Bariatric Surgery
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
3 Centers for Disease Control and Prevention. National Diabetes Statistics Report website 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/
5 Projected U.S. State-Level Prevalence of Adult Obesity and Severe Obesity https://www.nejm.org/doi/full/10.1056/NEJMsa1909301
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