Saniona obtained regulatory approval to initiate the second part of a Phase 2a study evaluating the investigative therapy Tesomet (tesofensine/metoprolol) in adolescents with Prader-Willi syndrome (PWS) after positive results from the first part of the study with adult patients.
Prader-Willi is a genetic disorder that begins in childhood. People with the disease always feel hungry, which often leads to obesity and type 2 diabetes. Tesofensine helps with weight loss in obese patients, and has the potential to reverse the progression of type 2 diabetes by reducing liver fat.
The clinical trial (NCT03149445), now recruiting adolescent participants for the second part, first tested Tesomet (a combination therapy of tesofensine 0.125 mg and metoprolol 25 mg daily) for 91 days in nine adults with PWS.
Study results from the adults revealed that Tesomet may help achieve a clinically meaningful weight loss and a significant reduction in hyperphagia (overeating). The clinical study was held in Prague, the Czech Republic.
“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. We are now continuing the study at a lower dose in adolescents with PWS,” Roman Dvorak, Saniona’s chief medical officer, said in a press release.
The second part of the trial will now enroll up to 10 teens with Prader-Willi to test the combination therapy. Patients will receive either Tesomet or placebo.
The study’s primary endpoint will be the change in body weight over 12 weeks of treatment. Secondary objectives are to examine eating behavior and hyperphagia, body composition, lipids, and other metabolic measurements.
Researchers will also study the tolerability, safety, and pharmacokinetic profiles of Tesomet in these younger patients.
Regarding safety, Tesomet has been well-tolerated in human clinical studies so far, although an increase in heart rate has been reported.
“We are excited to continue advancing Tesomet’s clinical development for Prader-Willi syndrome following encouraging results from our exploratory Phase 2a study in adult patients and positive discussions with key opinion leaders in the field,” said Jørgen Drejer, CEO of Saniona.
“We believe that low dose Tesomet could prove to be a compelling treatment for adolescents with this currently untreatable disease,” Drejer said. “Patients suffering from Prader-Willi syndrome currently face debilitating hyperphagia, which has severe consequences that also affect their families and carry a very high cost to payers and the society.”