The trial is comprised of a total of 60 volunteers.
February 7, 2018
Saniona, a leading biotech company in the field of ion channels, today announced that it has completed the recruitment of participants into the Phase 1 pharmacokinetic study of Tesomet using the new patented tablet. The trial is comprised of a total of 60 volunteers. The last participants have had the final visit and the obtained blood samples from this study have been forwarded to a laboratory for analysis. Saniona expects to report results from the trial in the second quarter of 2018.
“This Phase 1 study represents an important step in our preparation for the long-term Phase 2 studies with our new patented Tesomet fixed-dose combination tablets. We are pleased that the recruitment has been completed according to our plans and are looking forward to evaluate the results of using this innovative formulation in humans for the first time,” commented Jørgen Drejer, CEO of Saniona.
The primary objective of this Phase 1 study is 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.
This is a randomized, open-label, parallel-arm study in 60 healthy male subjects. Each subject will participate in a screening period, a baseline period, and a single-dose treatment period with an on-site observation period of at least 48 hours after the dose. The study is being conducted by Parexel in Germany at their clinical site in Berlin.
Further details about the trial 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 09:30 CET on February 7, 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. 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 5,300 shareholders. The company’s share is traded under the ticker SANION. Read more at www.saniona.com.
