Provides update on Tesomet and AN363

Saniona, a leading biotech company within ion-channel research, announces new clinical data, which strongly supports the use of Tesomet, a combination of Tesofensine and Metoprolol, for treatment of type 2 diabetes. Datamining of the results from previous human clinical trials shows that Tesofensine reduces glycemic parameters in prediabetes individuals participating in a Phase 2 study and that Metoprolol blunts the increase in heart rate caused by Tesofensine in volunteers in a Phase 1 study.

“The new analyses of previous studies lends strong support for the concept of using Tesomet in type 2 diabetes. They show that Tesofensine reduces glycated haemoglobin, HbA1c, a major key endpoint in clinical diabetes studies. Tesomet may ultimately present a treatment that could take early type 2 diabetes patients out of their diabetes”, says Jørgen Drejer, CEO of Saniona.

New clinical data supports the use of Tesomet for treatment of type 2 diabetes

Saniona intends to initiate a Phase 2a proof of concept study in 2016 in obese type 2 diabetes patients. The objective is to evaluate the effect of Tesomet (Tesofensine plus Metoprolol) in type 2 diabetes patients 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.

Saniona now reports new analyses of clinical data from previous clinical studies, which strongly support this concept.

Tesofensine demonstrated strong weight reducing effects in Phase 2 clinical studies in obese patients (TIPO-01 study). Saniona has now performed an additional datamining of the results from the TIPO-01 study. About 25% of the patients enrolled in the trial had elevated glycaemic parameters equal to the level of prediabetes patients (fasting glucose between 5.6 and 6.9 or HbA1c between 5.7 and 6.4). During the 24-week treatment period, the average glycated haemoglobin, HbA1c, fell from 5.9 to 5.5 in patients with elevated HbA1c. The average insulin level fell from 79.9 to 50.7 in patients with elevated glucose level. All these reductions were statistically significant to the comparator group receiving placebo despite the low number of patients.

“The fact that Tesofensine lead to a significant drop in glycated haemoglobin, HbA1c, a major key endpoint in clinical diabetes studies, is highly encouraging. Clinicians would expect an even higher and regulatory relevant effect in real type 2 patients who have passed the line from prediabetes to full-blown type 2 diabetics with higher HbA1c, a patient population which was excluded from the TIPO-01 study,” says Jørgen Drejer.

In general, Tesofensine has been well tolerated in humans. However, slight increases in blood pressure and more pronounced increases in heart rate were observed at therapeutic doses of Tesofensine. Saniona has now performed a datamining of a Phase 1 drug-drug interaction study where patients were treated for 14 days with Tesofensine alone followed by one day with a combination of Tesofensine and Metoprolol. As expected, treatment with Tesofensine alone increased heart rate in these volunteers. Indeed, also in humans the heart rate was reduced to normal levels upon administration with Metoprolol in addition to Tesofensine (Metoprolol has previously shown to reduce heart rate to normal levels in animal studies).

“The new clinical analyses strengthen the rationale for developing Tesomet for type 2 diabetes and we are looking forward to initiate the planned Phase 2a clinical study. The recently given Notice of Allowance for a US patent may provide patent protection until 2033 for Tesomet and the use of Tesomet in treatment of obesity and type 2 diabetes. This represents a very long patent period for a Phase 2 program and provides a unique starting position for going forward,” says Jørgen Drejer.

Preliminary preclinical toxicology data suggest a NOAEL of 10 mg/kg for AN363, but additional studies are warranted and Phase 1 studies will be delayed

Saniona announces that draft toxicology reports indicate that AN363 in general is well tolerated at the lowest doses selected and that AN363 appears to have a NOAEL (No Observed Adverse Effect Level) of 10 mg/kg. Saniona notes that a NOAEL of 10mg/kg supports initiation of Phase 1 studies. However, Saniona has decided to perform additional studies on a finding seen at higher doses in rats before initiating Phase 1.

Saniona reported in May that it had finalized the manufacturing of AN363 tox material for GLP animal studies and had completed the dose range finding studies in rats and dogs. In the GLP safety and toxicology studies in rats and dogs, AN363 showed high drug exposure and without critical clinical findings during the 28 days in life toxicology studies.

Saniona has now received most of the draft reports from the GLP safety and toxicology studies with laboratory results. According to the draft reports received so far, AN363 was generally well tolerated at the lowest doses studied and a preliminary NOAEL (No Observed Adverse Effect Level) of 10 mg/kg was found in both rats and dogs. Such toxicology studies are designed to identify a NOAEL and to identify the nature of adverse effects emerging in higher doses. Based on the draft reports, Saniona has now decided to further investigate one of the specific findings in rats, which occurred at higher doses causing the Phase I studies to be delayed. This finding was not observed in dogs even at the maximal dose.

“It is positive that we appear to get a NOAEL at 10mg/kg, which is used to establish a safe clinical starting dose in human trials. However, we have decided to further investigate a specific finding observed in rats in higher doses. This means that we need to postpone the initiation of the Phase 1 study to 2016,” says Jørgen Drejer, CEO.

Following a positive outcome of these investigations, Saniona can initiate the clinical Phase 1 trial at the Centre for Human Drug Research in Holland, CHDR. The Phase 1 study comprises a classical single ascending dose study followed by a multi ascending dose study and is expected to take 6-9 months. The trial comprises standard safety and pharmacokinetic readouts.

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 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 2,000 shareholders. The company’s share is traded under the ticker SANION. Read more at www.saniona.com.

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