Kintai Therapeutics Advances Anti-Obesity Agent KTX-0200 into IND-Enabling Studies Following Positive Preclinical Data Demonstrating Sustained Weight Loss and Improved Health Markers

Cambridge, Mass. – January 22, 2020 – Kintai Therapeutics, a Flagship Pioneering company, today announced the advancement of KTX-0200, a novel oral anti-obesity agent, into IND-enabling studies following the demonstration of sustained weight loss and improved markers of health in preclinical studies. Treatment with KTX-0200 led to sustained weight loss of 14% in chronic diet-induced obesity rodent models known to be predictive of clinical efficacy across anti-obesity drug mechanisms. In addition, treatment with KTX-0200 led to improved glucose tolerance (12% improvement in oral glucose clearance based on an oral glucose tolerance test) and increased insulin sensitivity (14.5% improvement in glucose clearance in an insulin tolerance test), demonstrating the potential utility of KTX-0200 in diabetes and pre-diabetes patients. Significant improvements in liver health were observed across multiple animal models, including the Gubra NASH model where treatment with KTX-0200 resulted in a 30% reduction of liver fat, a 19% decrease in total liver weight, and a 38% decrease in liver transaminases known to be an indicator of liver damage.

“Obesity is a growing epidemic with nearly 50% of the U.S. population expected to be obese by 2030, leading to devastating health consequences and costs,” said Paul Peter Tak, M.D., Ph.D., president and chief executive officer of Kintai. “Our preclinical data with KTX-0200 is promising, demonstrating sustained weight loss and improved glucose control and liver health markers. In addition to stand alone efficacy, KTX-0200 may potentially be an attractive medicine for combination therapy with current anti-satiety drugs, which we plan to evaluate. We look forward to presenting the detailed preclinical data at an upcoming scientific congress and beginning IND-enabling studies with KTX-0200.”

About KTX-0200 and Obesity

KTX-0200, an oral small molecule anti-obesity agent, was developed based on Kintai’s unique understanding of the role of the gut microbiome in human biology. In 12-week chronic mouse models of diet-induced obesity, KTX-0200 reduced body weight by 14%, as well as improved glucose control and liver health. Distinct from currently approved anti-obesity medicines, KTX-0200 was shown in a preclinical model to cause weight loss with little change in food consumption. Kintai has initiated IND-enabling activities for KTX-0200.

Obesity is a major driver of metabolic diseases, including type 2 diabetes, NASH, and cardiovascular diseases, and it contributes to cancer, immune-mediated inflammatory disease, and osteoarthritis. In the U.S., approximately 93 million adults and 14 million children were obese during 2015-2016.^1,2 The estimated annual medical cost of obesity was $147 billion in the U.S. in 2008.¹

About Kintai

Kintai Therapeutics is uniquely focused on unlocking the power of the enteric signaling network and its signals throughout the body to fight disease and restore health. The company’s Precision Enteric Medicine™ (PEM™) compounds are based on a deep understanding of the interconnected biology of the microbiome, gut immune system, and enteric nervous system. Kintai has pioneered a new frontier in gut science, resulting in a unique understanding of a wealth of new genes, metabolites, and signaling molecules, leveraging these insights to rapidly translate into a highly actionable pipeline. Through the company’s focus on human biology, experimental medicine, bioinformatics and machine learning, Kintai has created a discovery and therapeutic development approach to identify and deliver new medicines. Kintai’s multidisciplinary expertise and its technology platform has delivered a pipeline of programs across multiple therapeutic areas, including oncology, neurology, metabolic disease and immunology. Kintai believes that its core strength lies in the hearts and minds of its talented employees who keep patients at the center. Kintai was founded in 2016 by Flagship Labs, the innovation foundry of Flagship Pioneering. To learn more, please visit the company’s website at www.kintaitx.com.

¹ Centers for Disease Control and Prevention (2018, August 13). Adult Obesity Facts. Retrieved from https://www.cdc.gov/obesity/data/adult.html

² Centers for Disease Control and Prevention (2019, June 24). Childhood Obesity Facts. Retrieved from https://www.cdc.gov/obesity/data/childhood.html