The U.S. Food and Drug Administration (FDA) gave positive feedback to Saniona regarding its work to advance Tesomet as a possible treatment to aid weight loss in people with Prader-Willi syndrome (PWS).
Saniona now expects to file an investigational new drug (IND) application, asking to launch a Phase 2b trial of Tesomet in patients in the second half of this year. The FDA has agreed with the company’s plans for the design, dosing, and duration of the trial.
“The collaborative interaction with the FDA has given Saniona needed clarity to advance Tesomet development for Prader-Willi syndrome,” said Rudolf Baumgartner, chief medical officer and head of clinical development at Saniona, in a press release.
Tesomet is a combination of tesofensine and metoprolol. Tesofensine modulates brain activity by blocking the reuptake (re-entry) of three neurotransmitters, or signaling molecules — dopamine, serotonin, and noradrelinane — by neurons.
One potential side effect of tesofensine is an abnormal heart rate. Metoprolol, a beta blocker, is used to manage this potential effect.
Saniona is investigating Tesomet as a treatment for PWS and hypothalamic obesity, both characterized by uncontrollable appetite that causes excess weight and other complications.
In a previous Phase 2a clinical trial (NCT03149445), once daily treatment with Tesomet led to lower weight, body mass index (BMI) and greater control of hyperphagia — excessive eating due to an inability to feel full — in adolescents with PWS.
The higher dose of Tesomet (0.25 mg/day) resulted in a 69% decrease in hyperphagia scores — determined from a questionnaire asking caregivers about food-seeking habits — after three months of treatment compared with scores at the study’s start.
A Phase 2b trial will also use hyperphagia reduction as primary goal. The FDA will allow Saniona to use the 505(b)2 pathway in the application seeking Tesomet’s approval, which enables the inclusion of safety and efficacy data from studies not conducted by the company.
A separate Phase 2 trial (NCT03845075) is investigating Tesomet as a treatment for hypothalamic obesity. Preliminary data showed significant decreases in weight and waist circumference in patients taking Tesomet compared to a placebo group.
The study is currently in an open-label extension phase, with data expected by year’s end.
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