FPWR works closely with several clinical trial sponsors in order to help companies understand the medical needs and challenges of PWS, provide input into study protocols and educate the community about trial opportunities. Most recently, FPWR Director of Research Programs, Dr. Theresa Strong, was invited to participate on the Scientific Advisory Board for Saniona, a therapeutic company working on a new treatment for hyperphagia in PWS. Saniona will leverage the expertise of its Scientific Advisory Board as it develops its Phase 2b and 3 studies of Tesomet which are planned to take place in both the U.S. and Europe over the next 2 years. Read below for their recent press release.
Saniona forms PWS Scientific Advisory Board and provides update on ongoing study
Saniona (OMX: SANION), a biotech company focused on the central nervous system and eating disorders, announced today that it has established a Scientific Advisory Board for the development of Tesomet in PWS. Saniona has also extended the ongoing open label study in both Czech Republic and Hungary and the dose has been adjusted to 0.25 mg. This last extension of the study will be completed in July 2019.
May 13, 2019
“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. 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, which is expected to be conducted in the U.S. and Europe over the coming two years,” said Jørgen Drejer, CEO of Saniona.
The Scientific Advisory Board which recently met for the first meeting in Copenhagen comprises several highly regarded and influential experts from the U.S. and Europe with a profound experience in Prader Willi syndrome, including:
- Tony Holland, MD, CBE – Emeritus Professor of Psychiatry, University of Cambridge; President of the International Prader-Willi Syndrome Organisation
- Theresa Strong, PhD - Director of Research Programs, Foundation for Prader-Willi Research
- Janice Forster, MD – Child and Adolescent Psychiatrist in private practice in Pittsburgh, PA, specializing in Developmental Neuropsychiatry and Prader-Willi syndrome
- Susanne Blichfeldt, MD - Consultant (Paediatrics), Copenhagen; Vice-Chair, Clinical & Medical Advisory Board, International Prader-Willi Organization
“We had very productive meetings with the SAB 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 FDA and EMA later this year following the completion of the ongoing Phase 2a study, said Jørgen Drejer, CEO of Saniona.
Saniona is a research and development company focused on drugs for diseases of the central nervous system and eating disorders. The company has five programs in clinical development. Saniona intends to develop and commercialize treatments for orphan indications such as Prader-Willi syndrome and hypothalamic obesity on its own. The research is focused on ion channels and the company has a broad portfolio of research programs. Saniona has partnerships with Boehringer Ingelheim GmbH, Productos Medix, S.A de S.V and Cadent Therapeutics. Saniona is based in Copenhagen, Denmark, and the company’s shares are listed at Nasdaq Stockholm Small Cap (OMX: SANION). Read more at www.saniona.com.