Saniona Decides to Perform Interim Analysis of Tesomet Study in Patients With Prader-Willi Syndrome
October 26, 2017
Saniona, a leading biotech company in the field of ion channels, today announces that nine out of a planned ten adult patients with Prader-Willi syndrome have completed or discontinued from the Phase 2 clinical study. Some patients showed indication of weight loss and reduced craving for food, the key efficacy endpoints. Some patients discontinued the study due to adverse effects, which might be drug related. This interim analysis will last about 2-3 months and based on the results Saniona will decide on the next steps for Tesomet in Prader-Willi syndrome.
"Prader-Willy syndrome is a complex disease with a high occurrence of concomitant co-morbidities. Many patients have major behavioural and psychiatric abnormalities at the time they reach adulthood and communication represents a challenge when performing clinical studies. Based on our observations, we see a need to un-blind the study and analyse data on individual patient's drug exposure in relation to observed efficacy and safety signals before we decide on next steps", says Jørgen Drejer, CEO of Saniona.
The actual assignment of patients to respective treatment arms is currently unknown since the placebo controlled study is still blinded. The indications of a reduction in weight and craving for food are encouraging whereas the discontinuation of five patients due adverse effects, potentially drug related, may indicate that we have used a too high dose in this study.
"We highly appreciate the dedicated and professional efforts from the primary investigators Dr. Torok in Hungary and Dr. Kolouskova in the Czech Republic and their staff to find and manage these demanding patients", says Jørgen Drejer, CEO of Saniona.
For more information, please contact
Thomas Feldthus, EVP and CFO, Saniona, Mobile: +45 2210 9957, E-mail: tf@saniona.com
This information is information that Saniona (publ) is obliged to make public pursuant to the EU Market Abuse Regulation and Sweden's Securities Market Act. The information was submitted for publication, through the agency of the contact person set out above, at 12:45 CET on October 26, 2017.
About Saniona
Saniona is a research and development company focused on drugs for diseases of the central nervous system, autoimmune diseases, metabolic diseases and treatment of pain. The company has a significant portfolio of potential drug candidates at pre-clinical and clinical stage. The research is focused on ion channels, which makes up a unique protein class that enables and controls the passage of charged ions across cell membranes. Saniona has ongoing collaboration agreements with Boehringer Ingelheim GmbH, Proximagen Ltd., Productos Medix, S.A de S.V and Cadent Therapeutics. Saniona is based in Copenhagen, Denmark, where it has a research center of high international standard. Saniona is listed at Nasdaq Stockholm Small Cap and has about 5,100 shareholders. The company's share is traded under the ticker SANION. Read more at www.saniona.com.
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