Denmark-based biotech company Saniona has reported positive results from its Phase IIa clinical trial of Tesomet to treat type 2 diabetes.
Tesomet is a combination of tesofensine and metoprolol believed to treat metabolic syndromes and eating disorders, including Prader-Willi syndrome (PWS), binge eating, type 2 diabetes and fatty liver diseases such as NASH.
The Phase IIa trial included 60 patients who were administered with Tesomet and placebo.
The trial was primarily focused on establishing the efficacy of Tesomet as a result of reduction in heart rate compared with placebo.
Other important secondary and exploratory endpoints of the trial are to determine a reduction in weight and waist circumference as a result of treatment with Tesomet compared with placebo.
Results were indicative of the trial meeting its primary endpoint, with the mean heart rate reduced by an average of 4.3 beats per minute (bpm) compared with a 0.2bpm reduction as a result of placebo treatment.
The trial automatically met its secondary endpoints with reduced systolic and diastolic blood pressures recording a numerical reduction of 3.1 millimetres of mercury (mmHg) and 2.2mmHg.
Saniona CEO Jørgen Drejer said: "Our initial take on the data is that Tesomet has the potential to become a highly effective weight loss product with a benign safety profile that may reduce long-term cardiovascular risk factors.
“About 80% of patients with type 2 diabetes have cardiovascular risk factors, including high blood pressure. Data clearly supports that Tesomet can be targeted for this large group.
“Furthermore, we remain optimistic about the possibility to address glycemic endpoints in long-term studies due to the statistical significant reduction in weight loss seen already after 12 weeks and the numeric reduction in liver fat achieved in this study."
Out of the 60 patients, 58 completed the trial, while the other two patients were both in the placebo group.
The company noted that there was only one serious adverse event reported, which occurred in a patient dosed with placebo.
Dry mouth, nausea, impaired gastric emptying, fatigue, sweating, muscle spasm, dizziness, headache and restlessness were the most frequently reported adverse events in patients treated with Tesomet.