The News

7TM Pharma has initiated Phase I/IIa clinical trial with TM30339 for the treatment of obesity and related metabolic disorders

02/09/2008

Hoersholm – September 2nd, 2008:

7TM Pharma today announced that it has initiated a Phase I/IIa clinical trial with the drug candidate TM30339, which was discovered internally at 7TM Pharma and is being developed for treatment of obesity and related metabolic disorders.

The Phase I/IIa clinical trial is a double-blind, placebo-controlled 28-day study, which will enroll patients with a BMI (body mass index) of between 30 and 40, the definition of clinical to extreme obesity. The aim of the study is to determine the effective dose for inducing weight loss, for use in longer term weight loss trials and also to assess the safety and tolerability of TM30339. 7TM Pharma is conducting the study at multiple centers under an open IND in the US.

Christian E. Elling, Vice President, Biology and Development, commented: “TM30339 was the second clinical candidate delivered by our GI (gastrointestinal) hormone platform. In pre-clinical studies it demonstrated impressive results on body weight loss in diet induced obese animals. Our first clinical studies with this new exciting drug candidate not only demonstrated to us relevant effects on markers of obesity and diabetes, but also returned an impressive safety and tolerability profile that seems to differentiate it from other GI hormone mechanisms being developed in the industry today. With the present clinical study, we hope to take a significant step forward in bringing TM30339 forward to the benefit of the growing number of obese patients and the physicians who require safe and effective medicines.”

In a Phase I clinical study it was observed in healthy obese volunteers that TM30339 inhibited food intake and importantly suppressed the levels of Ghrelin, a “hunger signal” from the stomach.

7TM Pharma is progressing another GI hormone analogue, Obinepitide, for treatment of obesity and related metabolic disorders currently in Phase I/II, as well as a peripherally acting CB1 antagonist, TM38837, for treatment of obesity and related metabolic disorders. The company plans to initiate first clinical trials of TM38837 in H1, 2009.

Contact person:
Mette Kirstine Agger, CEO
Tel: +45 3925 7777
Email: agger@7tm.com

About TM30339
TM30339 has a novel mechanism of action compared to existing drugs for the treatment of obesity and it has the potential to become the first drug on the market with this mechanism. TM30339 is a close analogue of a natural hormone normally released from the pancreas in connection with food intake. This hormone is known to play a role as a satiety signal in connection with food intake and appetite regulation as well as in the regulation of metabolic parameters.

About Obesity
Obesity and related metabolic diseases are considered a very big health problem and a challenge to the industrialized world. Obesity significantly increases the risk of diseases such as cardiovascular diseases and Type 2 diabetes and involves significant costs in the 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 growing fast. In spite of this, there are only few available therapies for obesity. These drugs have a limited effect and significant side effects, and there is consequently a large, unmet need for new and better 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 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.
Since its inception in 2000, 7TM Pharma has raised DKK 610 million (EUR 82 million). Investors include Index Ventures, Novo A/S, Alta Partners, LD Pensions, Johnson & Johnson Development