Saniona Sets Goals for its Clinical Program of Tesomet for PWS

Saniona will continue to develop Tesomet (tesofensine/metoprolol) as a potential therapy for Prader-Willi syndrome (PWS), with results from a Phase 2a clinical study expected to be reported soon.

The company has completed a rights issue in which it sold some of Saniona’s shares, resulting in gross revenue of SEK 66.5 million (approximately $6.90 million), it was announced in a press release. This will aid in completion of the ongoing Phase 2a trial (NCT03149445) evaluating the impact of Tesomet in PWS patients and the initiation of discussions regarding the start of Phase 2b/3 clinical studies in 2020.

“It is an exciting period in the development of the company and our pipeline is advancing apace. Most importantly, we are now completing exploratory clinical efficacy and dose-finding studies of Tesomet in the rare eating disorder Prader-Willi syndrome,” Jørgen Drejer, CEO of Saniona, said in a press release.

Tesomet is an orally available therapy that results from a fixed-dose combination of tesofensine and metoprolol.

Tesofensine prevents the re-uptake of three main signaling molecules that regulate brain activity — serotonin, norepinephrine, and dopamine. By increasing the amounts of these neurotransmitters outside brain cells, tesofensine will prevent cell-to-cell communications in the brain and halt appetite sensation.

Studies have showed that treatment with tesofensine is associated with weight loss and liver fat reduction in obese people.

Despite its positive therapeutic effects, tesofensine use is associated with abnormal heart rate. Metoprolol, a beta blocker compound, is used to resolve this problem.

Saniona is exploring the therapeutic impact of Tesomet in PWS patients in a randomized, double-blind, placebo-controlled Phase 2a trial.

In the first part of the study, six adults with PWS were treated daily with Tesomet (0.5 mg of tesofensine and 50 mg of metoprolol) while three received a placebo formulation.

Results showed that those treated with Tesomet had clinically meaningful weight loss and a reduction in excessive eating (hyperphagia). As only four of the patients completed the trial — two who were treated with Tesomet and two who were administered the placebo — the researchers highlighted that the results must be interpreted with caution.

In the second part of the Phase 2a clinical trial, nine PWS adolescents were treated daily with a lower dose of Tesomet (0.125 mg of tesofensine and 25 mg of metoprolol). This lower dosage was found to be safe and well-tolerated, but it failed to achieve the plasma levels that were previously determined to be efficacious in clinical trials in adults. Thus, researchers increased the daily dose to 0.25 mg, which is currently being tested in a 24-week open-label extension study.

“We are looking forward to results of a dose-finding Phase 2a study of Tesomet in adolescent patients with PWS. The last patient visit was at the end of July, all blood samples have been shipped for analysis and the clinical team is in the process of validation and closing the database,” Drejer said. He added that results are expected to be announced in September.

The company recently announced that it had established a scientific advisory board to provide support for future Phase 2b and Phase 3 clinical studies of Tesomet in PWS patients.