Phase 2 Study Announced: Tesomet for PWS Weight Loss, Hyperphagia

Saniona has announced it will continue its phase 2 study of Tesomet for Prader-Willi syndrome. Saniona is developing Tesomet as a potential treatment for PWS patients to help with weight-loss and reduce hyperphagia (excessive hunger). The study, which had been divided into two parts, was paused while data from the first half of the study was analyzed.

According to Saniona, results from the study revealed that Tesomet may provide clinically meaningful weight loss and a significant reduction in hyperphagia. The study also revealed that patients with PWS should be given lower doses of Tesomet compared to other patient groups.

“The data supporting Tesomet for Prader-Willi patients has been impressive. During the first 3-month study, patients not only experienced a significant weight loss but also a remarkable reduction in cravings, measured by the hyperphagia questionnaire,” stated Dr. Roman Dvorak, Saniona Chief Medical Officer.

Nine adult patients were enrolled in the first part of the study. In the second part, the study will be continued at a lower dose in adolescents with PWS. Patients are now being enrolled for this 12-week study at Hospital Motol in Prague, with a target enrollment of 10 individuals. Study details along with inclusion and exclusion criteria are available on clinicaltrials.gov.

Saniona is pursuing an orphan indication for Tesomet for its use in PWS. “By pursuing an orphan indication such as PWS, we may develop and commercialize our own product in the U.S. and Europe within a relative short time and at a limited investment in an indication where the commercial opportunities appear to be very large,” said Jørgen Drejer, Ph.D., Saniona’s founder and CEO.

You can read Saniona’s press release about this announcement here.

For updated information on PWS clinical trial opportunities and to sign up for a monthly PWS Clinical Trial Alert, visit our PWS Clinical Trials page.

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Topics: News

Susan Hedstrom

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Susan Hedstrom is the Executive Director for the Foundation for Prader-Willi Research. Passionate about finding treatments for PWS, Susan joined FPWR in 2009 shortly after her son, Jayden, was diagnosed with Prader-Willi Syndrome. Rather than accepting PWS as it has been defined, Susan has chosen to work with a team of pro-active and tireless individuals to accelerate PWS research in order to change the natural history of PWS. Inspired by her first FPWR conference and the team of researchers that were working to find answers for the syndrome, she hosted her first One SMALL Step walk in 2010 and began the development of the One SMALL Step walk program which now raises over $1.5 million a year for PWS research.

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