The Food and Drug Administration (FDA) has granted Orphan Drug designation to Tesomet for the treatment of hypothalamic obesity, a rare disorder caused by physical or inborn damage to the hypothalamus.
Tesomet is an investigational fixed-dose combination therapy of tesofensine, a triple monoamine reuptake inhibitor, and metoprolol, a beta-1 selective blocker. The designation is supported by data from a 48-week phase 2 trial (ClinicalTrials.gov Identifier: NCT03845075), which consisted of an initial 24-week double-blind, placebo-controlled treatment period followed by a 24-week open-label extension period.
Findings showed that treatment with Tesomet led to statistically significant reductions in body weight, along with improvements in waist circumference and glycemic control, when compared with placebo. These improvements were sustained during the open-label extension period.
The most common adverse reactions reported with Tesomet included sleep disorders, dizziness, dry mouth and headache. No clinically meaningful differences in heart rate or blood pressure were observed between the Tesomet and placebo treatment arms.
“Despite the devastating weight gain and hunger this rare disease can cause, there has been relatively little drug development specifically for [hypothalamic obesity],” said Rudolf Baumgartner, MD, Chief Medical Officer and Head of Clinical Development at Saniona. The Company is planning to initiate a phase 2b study of Tesomet for hypothalamic obesity in the second half of 2021.
Tesomet was previously granted Orphan Drug designation for the treatment of Prader-Willi syndrome.
Saniona receives U.S. FDA Orphan Drug designation for Tesomet in hypothalamic obesity. News release. Saniona AB. Accessed July 26, 2021. https://www.globenewswire.com/news-release/2021/07/26/2268298/0/en/Saniona-Receives-U-S-FDA-Orphan-Drug-Designation-for-Tesomet-in-Hypothalamic-Obesity.html.