You are here

Saniona reports positive results from preclinical studies for Tesomet opening op for long-term clinical studies

PRESS RELEASE

June 5, 2018

Saniona, a leading biotech company within ion-channel research, today announced successful completion of the preclinical toxicology studies for Tesomet. The preclinical studies demonstrated that Tesomet is well tolerated and may be safely dosed in long-term Phase 2 and Phase 3 clinical studies.

“This important step stone enables us to perform long-term Phase 2 and Phase 3 clinical studies with Tesomet. We are developing Tesomet for severe eating disorders such as Prader Willi syndrome in the U.S and Europe and together with partners for metabolic diseases such as obesity. Our clinical trials for Tesomet have until now been limited to three months studies. Based on the positive preclinical results, we are confident to move into long-term Phase 2 and Phase 3 clinical studies with Tesomet. This will increase the flexibility of the design of important Phase 2 dose range finding studies in Prader Willi syndrome and be pivotal for future Phase 3 studies and market approval in both eating disorders and metabolic diseases”, commented Jørgen Drejer, CEO of Saniona.

Saniona has performed a preclinical toxicology study for Tesomet to enable long-term Phase 2 and Phase 3 clinical studies for Tesomet e.g. 6 months or longer. The preclinical study confirmed that Tesomet is well tolerated and that the combination of tesofensine and metoprolol has a high therapeutic index where the expected therapeutic dose is well below dose levels leading to potential adverse effects.

For more information, please contact

Thomas Feldthus, EVP and CFO, Saniona, Mobile: +45 2210 9957, E-mail: tf@saniona.com

This information is such information as Saniona AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 08:00 a.m. CEST on June 5, 2018.

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. Saniona has four programs in clinical development including three late stage clinical programs focused on the development of treatments to effectively regulate obsessions, cravings and addictions related to food and drugs. Saniona intends to develop and commercialize treatments for orphan indications such as Prader Willi syndrome on its own and engage in partnerships with larger entities for development programs aiming to treat large indications such as obesity. The company’s 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, Productos Medix, S.A de S.V and Cadent Therapeutics. Saniona’s research center 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.

Attachment

Tuesday, June 5, 2018 - 02:00