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Athersys Begins Trial For ATHX-105 For Treatment Of Obesity Milestone

Armen Hareyan's picture

Athersys has initiated a Phase I clinical trial in for ATHX-105, the company's oral, selective 5HT2c receptor agonist for treating obesity.

The serotonin 5HT2c receptor is a validated molecular target in the brain that regulates appetite and food intake. Compounds acting on this target have been shown to reduce appetite and result in weight loss in both animal models and humans. ATHX-105, which was developed internally, has been shown to stimulate the 5HT2c receptor without activating 5HT2b, a related receptor found in the heart and linked to adverse side effects affecting the cardiovascular system.

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"ATHX-105 has the potential to be a best-in-class compound, based on its potency, selectivity, and the potential for once-a-day, oral administration," said Dr. John Harrington, Chief Scientific Officer at Athersys. "In pre-clinical studies, ATHX-105 reduced food intake and body weight by suppressing appetite without appearing to cause the adverse side effects that have been observed with other weight loss drugs in this class."

The Phase I clinical trial, approved by U.K. regulatory authorities, will involve 60 to 80 overweight, healthy subjects with a body mass index of 25 to 35. The trial is designed to assess the short-term safety, tolerability, and pharmacokinetics of ATHX-105 and to establish dose ranges for evaluation of efficacy in subsequent clinical studies. In the first part of the trial, ATHX-105 will be given as a single dose which will be escalated until a maximum tolerated dose is identified. In the second part of the trial, ATHX- 105 will be administered in ascending doses for one-week to evaluate the safety and tolerability of multiple doses.

The safety evaluation will include the assessment of various cardiovascular parameters. The company expects to complete the trial in the first quarter of 2008. Concurrent with the Phase I clinical trial, Athersys is also conducting certain non-clinical studies needed for the commencement of subsequent clinical studies.