The positive results support the safe dosing of Tesomet in long-term Phase 2 and Phase 3 clinical trials, the company said.
Results also revealed that Tesomet, a fixed-dose combination of tesofensine and metoprolol, has a high therapeutic index, which means that the expected therapeutic dose is well under the amount thought to cause adverse effects.
While tesofensine is a triple serotonin-noradrenaline-dopamine reuptake inhibitor, metoprolol is a type of medication known as a beta-blocker. Tesofensine contributes to weight loss and may reverse the progression to type 2 diabetes by reducing liver fat, studies showed.
“Our clinical trials for Tesomet have until now been limited to [three-month] studies. Based on the positive preclinical results, we are confident to move into long-term Phase 2 and Phase 3 clinical studies,” Jorgen Drejer, CEO of Saniona, said in a press release.
Tesomet acts by normalizing the appetite of patients, reducing their extreme craving for food and increasing their metabolism. Prader-Willi patients experience constant, insatiable hunger, which commonly results in obesity and leads to type 2 diabetes.
A recently completed Phase 1 study (NCT03286829) testing Tesomet in 60 healthy volunteers showed that the treatment candidate provided clinically relevant and stable plasma levels of tesofensine and metoprolol, while also evidencing favorable tolerability results.
In January 2018, Saniona reported positive results from an exploratory Phase 2a clinical trial (NCT03149445) of Tesomet in Prader-Willi patients. Although researchers emphasized that results must be interpreted with caution given the low number of patients analyzed, they found that Tesomet induced significant weight loss over three months and reduced appetite compared with a placebo.
In April, the company obtained regulatory approval to begin the second part of the Phase 2a trial, which expects to include up to 10 adolescent and teen Prader-Willi patients, ages 12-17.
Investigators will assess Tesomet’s safety, tolerability, and pharmacokinetic (the study of a drug’s absorption, distribution, metabolism, and excretion).
Besides Prader-Willi syndrome, Saniona, based in Copenhagen, Denmark, is also partnering with other companies to develop Tesomet for obesity and other metabolic diseases.
“This will increase the flexibility of the design of important Phase 2 dose range finding studies in Prader Willi syndrome and be pivotal for future Phase 3 studies and market approval in both eating disorders and metabolic diseases,” Drejer said about the Phase 2a study results.