PRESS RELEASE
May 29, 2018
Saniona, a leading biotech company within ion-channel research, today announced successful completion of the Phase 1 pharmacokinetic study for Saniona’s novel patented Tesomet tablet. The Phase 1 pharmacokinetic study demonstrated that is possible to obtain clinical relevant and stable plasma levels of tesofensine and metoprolol in a wide dose range using Saniona’s novel proprietary fixed-dose combination tablet.
“This Phase 1 study represents the completion of comprehensive development work, which allows us to use the final fixed-dose combination tablets in our planned Phase 2 and Phase 3 studies within eating disorders such as Prader Willi syndrome and in metabolic diseases such as obesity. The study demonstrated that the Tesomet fixed-dose combination tablet delivers therapeutic blood levels of tesofensine and metoprolol to the human body in a manner that permits once a day dosing. We are very pleased about the results of this study where we have used this innovative formulation in humans for the first time,” commented Jørgen Drejer, CEO of Saniona.
This Phase 1 study was a randomized, open-label, parallel-arm study in 60 healthy male subjects. The primary objective of this Phase 1 study was to evaluate the pharmacokinetic profile and bioavailability of a single dose of the Tesomet fixed-dose combination tablet (containing both tesofensine and metoprolol) compared to the co-administration of separate tesofensine and metoprolol tablets.
The study was conducted by Parexel in Germany at their clinical site in Berlin. In general, and in accordance to previous clinical studies Tesomet was very well tolerated during the trial. Further details about the Phase 1 trial with the new combination tablet can be found at ClinicalTrials.gov: NCT03286829
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 12:25 CEST on May 29, 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 .
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