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7TM Pharma’s new first-in-class anti-obesity drug completes Phase I/II clinical studies


7TM Pharma’s new first-in-class anti-obesity drug completes Phase I/II clinical studies

Denmark – 20 March 2006:
7TM Pharma today announced positive results from its clinical Phase I/II study with its lead compound TM30338, a dual Y2-Y4 receptor agonist developed for the treatment of obesity and related diseases. Both the primary and secondary objective of the study were met. Thus, the study demonstrated that the drug candidate is safe and well tolerated in man. Importantly, in obese human subjects once-a-day subcutaneous (s.c.) dosing of TM30338 inhibited food intake at a statistically significant level up to at least 9 hours after dosing.

Christian E. Elling, Director of Development commented: “This study returns the positive results we expected for this promising synthetic hormone, not only on its safety and tolerability, but importantly also with respect to efficacy, supporting our aggressive planning towards the further clinical development of this molecule”.

Based on the promising phase I/II data, a substantial Phase IIa clinical study with TM30338 is currently being planned. Furthermore, pre-clinical development of 7TM Pharma’s next clinical candidate for the obesity indication, a selective Y4 receptor agonist peptide, was initiated last year and the company expects to initiate phase I/II studies on TM30339 in 2006. Both of these programs which are within the core therapeutic area of 7TM Pharma – i.e. obesity and related metabolic diseases – are still fully owned by the company.

“From idea to initial proof-of-concept in obese human subjects in less than two years is an impressive track record for 7TM’s drug discovery engine and development team,” says Thue W. Schwartz, CSO.

Through detailed structural insight and knowledge about drug-receptor interactions 7TM Pharma has developed TM30338 as a first-in-class compound, which in a single drug targets both the Y2 and the Y4 receptor with similar and very high potency. The Y2 and the Y4 receptors have both previously been validated in man as independent appetite suppressive drug targets through the use of the natural hormones. In pre-clinical studies in diet-induced obese animals the dual active TM30338 has demonstrated clear superiority in respect of long term reduction in body weight reduction as compared, for example, to the natural hormone PYY3-36, which only targets the Y2 receptor.


Study details
Safety and tolerability - Single s.c. doses of TM30338 administered to healthy human subjects with normal body weight were safe and well tolerated and allowed a maximal well tolerated dose to be defined. TM30338 administered to healthy obese subjects both once-a-day and twice-a-day for multiple days was also safe and well tolerated. There were no withdrawals due to adverse events and no serious adverse events were reported. There were no apparent trends in the clinical laboratory data across the entire single dose range or following the multiple once- or twice-a-day dose regimens. Neither were there any apparent trends in, for example, the vital signs or ECG parameters in subjects exposed to TM30338.
Efficacy - In a double-blind, cross-over design performed in healthy obese subjects food intake was statistically significantly suppressed by TM30338 as compared to placebo. This was observed both in the once-a-day and twice-a-day treatment regimen. Importantly, in the once-a-day regimen the compound was administered more than 9 hours prior to the test meal.

About TM30338
TM30338 is a synthetic analogue of two natural human hormones, PYY and Pancreatic Polypeptide, which normally are released during a meal. These hormones are known to play a role in the regulation of food intake and appetite in man as satiety signal from the GI-tract to the CNS. In TM30338, the properties of both of these hormones have been implanted into a single molecule.

About obesity
Obesity and the metabolic syndrome are considered a major health problem and challenge to th


Publisher Contact Information:

7TM Pharma A/S
+45 3925 7777
agger@7tm.com

Company profile of 7TM Pharma A/S
Past press releases of 7TM Pharma A/S.

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