Saniona Reports Positive Topline Results from Tesomet Phase 2 Open-Label Extension Study in Hypothalamic Obesity
November 23, 2020
Saniona (OMX: SANION), a clinical stage biopharmaceutical company focused on rare diseases, today announced positive top-line results from the Phase 2 open-label extension study of Tesomet in patients with hypothalamic obesity (HO). Patients treated with Tesomet for nearly one year (24 week double-blind [DB] followed by 24 week open label extension [OLE]) demonstrated statistically significant and clinically meaningful reductions in body weight and waist circumference, as well as improvements in glycemic control. No clinically meaningful differences in heart rate or blood pressure were observed over the course of the trial.
“Hypothalamic obesity is a rare disorder characterized by severe and debilitating obesity that is often complicated by depression, impulse control issues, complicated symptoms from necessary replacement of pituitary hormones, and increased risk of cardiometabolic disorders. There are no treatments specifically approved for HO, and standard weight loss approaches such as surgery, medication and lifestyle counseling are mostly ineffective in this rare disease,” said Professor Ulla Feldt-Rasmussen, M.D., DMSc., Department of Medical Endocrinology and Metabolism, Rigshospitalet Copenhagen University Hospital and Principal Investigator on the Phase 2 study. “The data from this nearly year-long study demonstrate the potential of Tesomet to help manage multiple key symptoms of HO – not only weight gain but also the metabolic dysfunction that can lead to serious diabetic complications. I look forward to the evaluation of Tesomet in further clinical studies.”
“The results of the open-label extension study reinforce the promising profile of Tesomet observed in the placebo-controlled portion of the Phase 2 study in patients with hypothalamic obesity,” said Rudolf Baumgartner, M.D., Chief Medical Officer and Head of Clinical Development of Saniona. “If approved, Tesomet could be the first treatment designed to address this rare disease. We look forward to continuing our discussions with the FDA and clarifying the path to bring Tesomet to the HO patients who desperately need treatment options.”
Highlights from top-line open-label extension study data include:
About the Phase 2 Study
All 18 patients who completed the DB period of the study were provided the opportunity to receive Tesomet in an open-label extension (OLE) period of the study for an additional 24 weeks. All 18 patients chose to participate in the OLE period, and all patients completed the OLE period. Patients entering the OLE were 83.3% female and on average 44.9 years old, weighing 110.4 kg (243 lbs) with a BMI of 37.2 kg/m2. Further details about the trial can be found at ClinicalTrials.gov.
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This information is such information as?Saniona?AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at?17:00?CET on November?23, 2020.?
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