7TM Pharma's new first-in-class anti-obesity drug completes Phase I/II clinical studies
7TM Pharma 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.
Based on the 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.
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.
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.
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