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.