Saniona initiates preparation of Phase 2a study
Saniona, a leading biotech company within ion-channel research, initiates a Phase 2a proof of concept study for the combination of Tesofensine and Metoprolol for treatment of type 2 diabetes in 2016. The company is now initiating the manufacturing of study materials for the trial. In addition Saniona, announce that it has received notice of allowance in the U.S. covering the combination.
“This is another important step for us as we are transforming from pre-clinical stage to a company with clinical activities”, says Jørgen Drejer, CEO of Saniona.
Saniona intends to initiate a Phase 2a proof of concept study in 2016. The Phase 2a study is expected to enrol obese type 2 diabetes patients. The objective of the study is to evaluate the effect of Tesofensine and Metoprolol in humans in relation to prevention of the increase in heart rate caused by Tesofensine while retaining the benefit of Tesofensine on weight loss and glycaemic parameters.
As a first step in the development, Saniona has entered into an agreement with the Swedish company Camprex (Karlskoga), who will be responsible for re-validating the existing batch of Tesofensine for new clinical studies. Furthermore, Saniona has entered into an agreement with the French company Delpharm, which will be responsible for the formulation, production and validation of the study material.
In addition, Saniona has received notice of allowance for U.S. patent application (US14/379,032) covering the combination of Tesofensine and Metoprolol. The new product will be called Tesomet. Patent issuance will provide IP protection for Tesomet in the U.S. until 2033 plus a potential patent extension period.
This invention covered by the U.S. patent application relates to the use of pharmaceutical compositions comprising a therapeutically effective combination of Tesofensine and Metoprolol for preventing the cardiovascular side effects of Tesofensine, while leaving the robust inhibitory efficacy on food intake and body weight loss unaffected. The patent claims cover a method of treatment, prevention or alleviation of obesity, type 2 diabetes and other obesity associated disorders, a pharmaceutical composition of Tesofensine and Metoprolol for use as a medicament and a kit comprising Tesofensine and Metoprolol as well as the use hereof.
“We are now gearing up to commence a Phase 2a study in type 2 diabetes for Tesomet. The Notice of Allowance is an important addition to the intellectual property estate on the Tesomet combination,” 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
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 agreement with Saniona’s Boston based spinout Ataxion Inc., which is financed by Atlas Venture Inc. and Biogen Idec Inc. Saniona is based in Copenhagen, Denmark, where it has a research center of high international standard and 18 employees. Saniona is listed at AktieTorget since April 2014 and has about 2,000 shareholders. The company’s share is traded under the ticker SANION. Read more at www.saniona.com.