Hoersholm – January 20th, 2010: 7TM Pharma today announced that it has successfully conducted and completed a Phase I clinical trial with the drug candidate TM38837, which was discovered internally at 7TM Pharma and is being developed for treatment of obesity and related metabolic disorders.
The Phase I clinical trial was a first in man single ascending dose study in healthy male subjects with additional cohorts in other populations. The aim of the study was to determine the safety and tolerability of a range of single ascending doses of TM38837 and additionally to describe the pharmacokinetic properties of the compound.
TM38837 is a first in class, second generation CB1 receptor antagonist. It was designed to circumvent the risk of psychiatric side effects displayed by the first generation CB1 receptor antagonists, through its restriction to peripherally located CB1 receptors in the body. This approach is in contrast to the first generation CB1 receptor antagonists, which also targeted CB1 receptors within the central nervous system. Although clinically effective, these had an unfavorable psychiatric side effect profile including depression and anxiety.
Christian E. Elling, Vice President, commented: “The first generation CB1 antagonists showed great promise as a therapy for obesity and the related diseases such as diabetes. However, they were troubled by risks of psychiatric side effects. With TM38837 we have engineered a new second generation compound which aims to circumvent exactly these issues, to realize the clinical beneficial effects already proven by the CB1 pharmacology. This first in man clinical study presented an excellent safety and pharmacokinetic profile. The results have encouraged us to move TM38837 forward in clinical development. We intend to partner the program during clinical development to further accelerate the program to the benefit of the growing number of obese patients requiring safe and effective medicines”.
About TM38837
TM38837 is a small molecule CB1 receptor antagonist discovered and developed internally at 7TM Pharma. Beyond a clinical development enabling program, TM38837 has completed a spectrum of in vivo studies supporting the thesis of peripheral restriction whilst maintaining efficacy in a range of models of obesity and metabolic disorders.
About obesity and related metabolic diseases
Obesity and related metabolic diseases are considered to be a major health problem and 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 kg/m2 – 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 the clinical development of drugs with a primary therapeutic focus on obesity, gastrointestinal diseases and with its partner Ortho-McNeil-Janssen Pharmaceuticals (a Johnson and Johnson company) inflammation. 7TM Pharma’s approach is to actively seek licensing partners during early clinical development. 7TM’s investors include Novo A/S, Alta Partners, LD Pensions, Scottish Widows Investment Partnership, Index Ventures, Sofinnova Capital, SR One, Global Life Science Ventures and GIMV. For more information on 7TM Pharma, please visit www.7tm.com.
