Saniona on track to start Phase 2 study with Tesomet

Saniona, a leading biotech company in the field of ion channels, today announces that it has taken another important step in order to start a Phase 2a clinical study with Tesomet and has now initiated the manufacturing of the tablets for the Phase 2a clinical study.

Saniona has initiated the manufacturing of the tablets after its partner, the Swedish company Cambrex Karlskoga AB, has completed the validation of tesofensine drug substance (one of the active ingredients in Tesomet) and released it for clinical studies in humans. The other active ingredient in Tesomet, metoprolol, is already available for clinical use in humans.

“The preparation of the Phase 2a clinical trial is progressing in accordance to the plan. We are in parallel finalising the Clinical Trials Application with the objective of initiating the Phase 2a clinical study in Germany for type 2 diabetes during the first half of 2016,” 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 Tesomet:
Tesomet is a fix-dosed combination of tesofensine and metoprolol, which Saniona plans to position for treatment of type 2 diabetes.

Tesofensine is a monoamine reuptake inhibitor that has demonstrated strong weight reducing effects in Phase 2 clinical studies in obese patients. The compound has the potential to reverse the progression of type 2 diabetes by reducing liver fat. The market for type 2 diabetes is estimated to grow from US $ 23 billion in 2014 to 43 billion USD 2023 due to the increasing problems with obesity. Type 2 diabetes is considered as a progressive chronic disease today. However, recent published research concludes that type 2 diabetes is reversible and that large patient populations may undergo long-term remission if they achieve a substantial weight loss through reduced food consumption. Saniona believes that tesofensine represents an interesting new treatment option for type 2 diabetes, which not only may be used in parallel with existing treatments, but also may offer potentially long-term remission in many patients by contributing to a substantial weight loss.

In general, tesofensine has been well tolerated in human clinical studies. However, an increase in heart rate has been observed at therapeutic relevant doses of tesofensine. Patent applications have been filed in respect of the combination tesofensine and a beta blocker. The invention covered by the patent applications is based on the demonstration in preclinical studies that the robust weight reduction seen with tesofensine is maintained when co-treatment with a beta-blocker was used to eliminate any heart rate increase by tesofensine. Saniona has received notice of allowance of a U.S. patent application, which includes a combination of tesofensine and metoprolol and which can provide protection in the United States until 2033, if issued. The combination product is covered by other recent Saniona patent applications with broad geographic coverage.

Saniona has recently published new results from datamining of previous clinical studies, which show that tesofensine improved glycemic parameters in prediabetes individuals participating in a Phase 2 obesity study and that metoprolol blunts the increase in heart rate caused by tesofensine in volunteers in a Phase 1 study.

Saniona expects to initiate a Phase 2a study during the first half of 2016 for Tesomet in type 2 diabetes patients. The aim of the study is to evaluate the effects of tesofensine and metoprolol in humans in relation to the prevention of cardiovascular side effects of tesofensine while retaining the advantage of tesofensine for weight loss and glycemic parameters. In the event that Saniona can demonstrate that type 2 diabetes patients achieve a weight reduction and a normalization of glycemic parameters without an increase in heart rate, the next step would be to initiate a larger clinical trial on diabetic patients. Saniona believes that there is a significant commercial potential for Tesomet if the Phase 2a study is successful. It is the ambition to seek licensing partners for the project after the Phase 2a study.

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 an 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 3,000 shareholders. The company’s share is traded under the ticker SANION. Read more at www.saniona.com.

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