The News

Positive results from two clinical Phase I studies with the drug candidate TM30339 for the treatment of obesity

27/02/2008

Hørsholm – 27 February, 2008

7TM Pharma today announced positive results from two clinical studies, a Phase Ia single ascending dose and a Phase Ib multiple ascending dose clinical study with TM30339. TM30339 was discovered internally at 7TM Pharma and is being developed for treatment of obesity and related metabolic diseases.
The Phase Ia clinical study was a randomized, double-blind, placebo-controlled single ascending dose study evaluating the safety, tolerability and pharmacokinetics of TM30339. The study demonstrated that TM30339 possess an excellent safety and tolerability profile when single doses are administered resulting in very substantial and persistent plasma levels of the drug.
The randomized, double-blind, placebo-controlled multiple ascending dose Phase Ib clinical study in obese patients confirmed this excellent safety and tolerability profile including up to 14-days of dosing.

TM30339 works through the Y4 receptor like the natural satiety hormone, Pancreatic Polypeptide, but TM30339 has improved properties over Pancreatic Polypeptide. Thus, TM30339 mimics a natural satiety signal from the gastrointestinal tract involved in the regulation of food intake in man. In pre-clinical studies, the Y4 receptor selective TM30339 was highly efficacious with respect to long term body weight reduction and improvements in related plasma markers of obesity.
Christian E. Elling, Director of Clinical Development commented: “We are encouraged by these first studies of TM30339 in man. The results obtained confirm our high expectations to the safety and tolerability from pre-clinical studies. This safety profile is necessary for a product towards obesity and related metabolic diseases considering the chronic use of such medicine. The results support further development of TM30339 for the treatment of obesity”.

7TM Pharma expects to initiate a clinical Phase II study with TM30339 in H1 2008.
Obesity and related metabolic diseases are considered a serious health problem and a challenge to the industrialized world. Obesity substantially increases the risk of developing cardiovascular diseases and Type 2 diabetes and contributes to significant costs in healthcare budgets. According to the WHO, there are more than 400 million clinically obese people worldwide – i.e. people with a BMI of more than 30 – and the number is increasing rapidly. In spite of this, there is only a handful of therapeutics available. These drugs have a limited efficacy with significant side effects, thus there is a large, unmet need for new and safer therapies.

About 7TM Pharma
7TM Pharma is a biotech company focusing on discovery and development of new drugs targeting 7TM receptors. 7TM Pharma’s primary therapeutic area is metabolic diseases, including obesity, Type 2 diabetes and cardiovascular diseases.
The basis for 7TM Pharma’s drug discovery is a thorough and comprehensive knowledge about 7TM receptors including their structure, function and pharmacology which the company uses in the design of new potential drugs. In recent years, the company has established a broad pipeline of research and development programs based on in-house drug discovery and development, and entered into several research partnerships, including with Ortho-McNeil Inc. (a subsidiary of Johnson & Johnson).
Since its inception in 2000, 7TM Pharma has raised DKK 610 million (EUR 82 million). Investors include I