Biotech company Saniona announced the formation of a scientific advisory board to supervise and guide the developmental program of Tesomet (tesofensine/metoprolol) for patients with Prader-Willi Syndrome (PWS).
The company also extended its Phase 2a open-label study (NCT03149445), testing the safety and efficacy of the treatment, in the Czech Republic and Hungary.
Tesomet is a combination of the medications tesofensine and metoprolol, a triple serotonin-noradrenaline-dopamine reuptake inhibitor and a beta blocker, respectively.
Treatment with tesofensine is associated with weight loss and liver fat reduction, and subsequent amelioration of type 2 diabetes. Beta blockers like metoprolol are medications that can help manage abnormal heart rate, a reported feature associated with tesofensine treatment.
“Tesomet has demonstrated reductions in craving for food and weight in the rare genetic eating disorder Prader-Willi Syndrome, and we are now planning for the final clinical and regulatory program targeting a billion-dollar market,” Jørgen Drejer, CEO of Saniona, said in a press release.
Previously, the Phase 2a study showed that 0.125 mg per day of Tesomet was safe and well-tolerated by study subjects. However, because the dosage failed to produce the plasma levels observed earlier with 0.5 mg daily dosage, researchers adjusted the current daily dose on the ongoing open-label study to 0.25 mg. Saniona expects to complete the study extension in July.
“Saniona has established a highly esteemed advisory board to oversee the program and provide guidance for the design of the final Phase 2b and Phase 3 studies … expected to be conducted in the U.S. and Europe over the coming two years,” Drejer said.
The scientific advisory board, which recently had its first meeting in Copenhagen, Denmark, is made up of experts in PWS from the U.S. and Europe, including:
- Tony Holland, MD, emeritus professor of psychiatry at the University of Cambridge, U.K., and president of the International Prader-Willi Syndrome Organisation;
- Theresa Strong, PhD, director of research programs at the Foundation for Prader-Willi Research;
- Janice Forster, MD, child and adolescent psychiatrist in Pittsburgh, specializing in developmental neuropsychiatry and PWS;
- Susanne Blichfeldt, MD, consultant (pediatrics) in Copenhagen, and vice chair at the Clinical & Medical Advisory Board, International Prader-Willi Organization.
“We had very productive meetings with the [scientific advisory board] and are looking forward to continued constructive interactions with this highly experienced group of people, whose first task is to review our clinical plans and provide advice when preparing for the Phase 2b and Phase 3 meetings with the [Food and Drug Administration] and [European Medicines Agency] later this year following the completion of the ongoing Phase 2a study,” Drejer said.