Saniona Announces Partnership with the Foundation for Prader-Willi Research (FPWR) to Support its Prader-Willi Syndrome (PWS) Clinical Trial with Tesomet

PRESS RELEASE

April 19, 2021

Saniona (OMX: SANION), a clinical stage biopharmaceutical company focused on rare diseases, today announced it has entered into a partnership with the Foundation for Prader-Willi Research (FPWR) to increase awareness within FPWR’s community about Saniona’s Phase 2b clinical trial of Tesomet for the treatment of Prader-Willi syndrome (PWS), which is expected to initiate in the first half of 2021.

“There are currently no approved treatment options to manage hyperphagia, the uncontrollable hunger that is one of the most difficult symptoms of PWS, making clinical trials a high priority for the PWS community,” said John Walter, CEO of FPWR. “We are pleased to partner with Saniona on this program to empower patients to learn about the clinical trial process, ensure that the patient view is represented throughout the clinical trial continuum, and raise awareness of Saniona’s clinical trial within the PWS community.”

As part of the collaboration, Saniona and FPWR will conduct a webinar with the PWS community to provide information and answer questions about Saniona’s PWS clinical trial. FPWR will also utilize its online, email and social media platforms to raise awareness of Saniona’s clinical trial.

“We are grateful to partner with FPWR because one of our top priorities is to incorporate caregiver and patient feedback into our clinical trial actitvities to ensure we meet the needs of the PWS community,” said Rudolf Baumgartner, M.D., Chief Medical Officer and Head of Clinical Development at Saniona. “We look forward to working with FPWR to gather this feedback and to increase awareness of our clinical trial.”

Saniona previously evaluated Tesomet in a randomized, double-blind, placebo-controlled Phase 2a trial in adults and adolescents with PWS. Adult patients receiving Tesomet achieved a statistically significant reduction in hyperphagia, as well as a clinically meaningful reduction in body weight at a dose of 0.5 mg per day. A smaller study extension in an adolescent population showed that Tesomet appeared to be well tolerated at lower doses (0.125 mg/day and 0.25 mg/day) and suggested dose-dependent effects on weight and hyperphagia.