Biotech company Saniona recently announced that the Phase 1 pharmacokinetic study of a new tablet therapy candidate for Prader-Willi syndrome, called Tesomet (tesofensine/metoprolol), produced promising results in healthy men.
Prader-Willi syndrome (PWS) is an inherited disorder that creates feelings of constant hunger, which often leads to obesity and type 2 diabetes.
Tesomet is a fixed-dose combination of tesofensine and metoprolol. It acts by normalizing appetite, reducing the craving for food, and increasing a patient’s metabolism.
Tesofensine helps with weight loss in obese patients and has the potential to reverse the progression of type 2 diabetes by reducing liver fat. In previous clinical studies, it has been seen to be well-tolerated, although increases in heart rates have been reported.
The recently completed Phase 1 study (NCT03286829) assessed Tesomet in 60 healthy men. The study’s primary objective was to evaluate the pharmacokinetic profile and bioavailability of a single dose of Tesomet fixed-dose combination tablet compared to the joint administration of tesofensine and metoprolol tablets separately.
Results showed that it is possible to obtain clinically relevant and stable plasma levels of tesofensine and metoprolol in a wide dose range using Tesomet’s fixed-dose combination tablet.
In general, and similar to previous clinical studies, Tesomet was well-tolerated during the trial.
“This Phase 1 study represents the completion of comprehensive development work, which allows us to use the final fixed-dose combination tablets in our planned Phase 2 and Phase 3 studies within eating disorders such as Prader Willi syndrome and in metabolic diseases such as obesity,” Jørgen Drejer, chief executive officer of Saniona, said in a press release.
“The study demonstrated that the Tesomet fixed-dose combination tablet delivers therapeutic blood levels of tesofensine and metoprolol to the human body in a manner that permits once-a-day dosing. We are very pleased about the results of this study where we have used this innovative formulation in humans for the first time,” Drejer added.
Because only four of the nine patients enrolled in the trial completed treatment, the results should be interpreted with caution. However, researchers were able to observe clinically meaningful weight loss over three months in patients treated with Tesomet compared with a placebo.
Not only was a change in body weight observed, but also a reduction in hyperphagia, or abnormally increased appetite, was reported at the end of the study.
In April, Saniona obtained regulatory approval to start the second part of the Phase 2a study, which aims to enroll up to 10 teenagers with PWS to test the combination therapy. Researchers will study the tolerability, safety, and pharmacokinetic profiles of Tesomet in these younger patients.