New Deal Will Fund Development of Tesomet for PWS, Saniona Says

A new funding deal will aid Saniona‘s development of Tesomet (tesofensine/metoprolol), a potential therapy to help control appetite and weight in people with Prader-Willi syndrome (PWS) and hypothalamic obesity, the company said.

Saniona is planning to conduct a Phase 2b/3 trial, which the Denmark-based company expects will support regulatory approval of Tesomet in the U.S. and Europe.

This experimental treatment is a combination of tesofensine and metoprolol.

Tesofensine works by preventing the reentry into brain cells of serotonin, norepinephrine, and dopamine — three signaling molecules that regulate brain activity. Since boosting the amounts of these neurotransmitters outside brain cells may lower appetite, treatment with tesofensine is associated with weight loss and liver fat decrease. Such weight loss benefits have been shown among obese participants of a Danish Phase 2 trial (NCT00394667) testing tesofensine.

However, treatment with tesofensine can cause heart rate irregularities. The use of metoprolol, a beta-blocker, is intended to prevent this side effect. Metoprolol affects the heart and circulation, improving blood flow through arteries and veins.

Tesomet was recently tested in adolescents with Prader-Willi syndrome in a Phase 2a clinical trial (NCT03149445). The results showed that a 0.25 mg/day oral dose of Tesomet led to reduced appetite and weight loss over six months. Prior findings of the first part of the study had revealed similar benefits in three adults with the disorder over three months.

The new funding deal will help secure resources for Tesomet’s subsequent trials. Specifically, Saniona sold new shares of stock to Formue Nord, a Denmark investment company. In total, 1 million shares were sold at SEK 25 (about $2.65) per share, for a total value of 25 million SEK (around $2.64 million).

Saniona also agreed to a loan totaling another 25 million SEK ($2.64 million) from Formue Nord. Altogether, the financing may result in SEK 158 million (about $16.69 million) to support Saniona’s activities.

“The funding we have secured from Formue Nord … will allow Saniona to pursue further development of Tesomet by itself in Prader-Willi syndrome and hypothalamic obesity,” Rami Levin, Saniona’s CEO, said in a press release.

“We have compiled encouraging proof of concept data on this promising treatment and are now preparing for meetings with U.S. and European regulators, with the aim of filing an Investigational New Drug (IND) application to initiate a pivotal Phase 2b/Phase 3 program, which will form the basis of our filings for approval,” Levin added.