Saniona AB (STO:SANION), a biotechnology company focused on the central nervous system and eating disorders, announced on Monday the recruitment of the first patient in a phase 2a clinical study of Tesomet to treat the rare eating disorder, hypothalamic obesity.
This trial comprised of a total of up to 25 patients and is conducted at Rigshospitalet in Copenhagen, Denmark. Reportedly, the purpose of this study is to investigate the overall safety and tolerability as well as effect on satiety, appetite and weight loss of Tesomet in patients with hypothalamic obesity.
In this exploratory randomised, double-blind, placebo-controlled study, patients will receive either Tesomet (tesofensine 0.5 mg + metoprolol 50 mg daily) or matching placebo (2:1 randomisation) for 24 weeks followed by an open-label extension study where all patients will receive Tesomet for 24 weeks, resulting in a total treatment period of 48 weeks. Saniona expects to report the results from the double-blind part of the study in Q4 2019 and the full study in H1 2020.
The primary endpoint is overall safety and tolerability, which will be judged from all safety data collected during the study, including recorded adverse events, laboratory data, blood pressure and heart rate. The secondary endpoints examine Tesomet's effects on satiety and appetite; bodyweight; body composition; lipids and metabolic parameters; quality of life; and craving for sweet, salty and fatty foods.
Hikma announces Health Canada approval of KLOXXADO Nasal Spray for opioid overdose treatment
Plus Therapeutics secures FDA Orphan Drug Designation for Rhenium (186Re) Obisbemeda
Latigo Biotherapeutics' LTG-001 receives US FDA Fast Track designation
GenSight Biologics reports positive five-year resultsfor LUMEVOQ gene therapy
Bain Capital to acquire Mitsubishi Tanabe Pharma in USD3.3bn deal
Innovent and ASK Pharm's limertinib NDA receives Chinese regulatory approval
Anavex reports positive long-term data for blarcamesine in early Alzheimer's disease
Johnson & Johnson agrees acquisition of Intra-Cellular Therapies Inc
Neuraxpharm acquires Provigil and Nuvigil to expand CNS portfolio
Nuvation Bio secures NMPA approval for taletrectinib in China
JCR Pharmaceuticals and Modalis Therapeutics advance to next phase of joint gene therapy research
PTC Therapeutics submits vatiquinone NDA to US FDA
Mitsubishi Tanabe Pharma forms research collaboration with Dewpoint Therapeutics
IXICO signs commercial agreement with PETNET Solutions to enhance neuroimaging capabilities