Athersys has released the results from its Phase 1 clinical trial of ATHX-105, its orally administered drug candidate for the treatment of obesity, which the company said was well-absorbed, provided good drug exposures, well-tolerated up to high doses and had no negative effect on cardiovascular, hematology or other clinical parameters.
“We believe that these results support the view that better selectivity results in superior tolerability for drugs in this class, which is an important factor for achieving effectiveness and patient compliance,” said Gil Van Bokkelen, PhD, chairman and CEO of Athersys.
The Phase 1 clinical study was a randomized, double-blinded, placebo controlled study in healthy male and female volunteers to evaluate the safety, tolerability, and pharmacokinetics of ATHX-105, according to the Cleveland-based company.
Athersys said the study was carried out in two parts – a single ascending dose portion and a multiple ascending dose portion, evaluating daily dosing for seven days, and was conducted in the United Kingdom. In total, 107 subjects were evaluated.
The company said that the highlights of the study include:
- The single ascending dose part evaluated doses of 2, 6, 20, 50, 100 and 150 mg of ATHX-105. The maximum tolerated dose was determined to be 100 mg. At high doses, the most common side effects included headache, nausea and dizziness.
- The multiple ascending dose part evaluated doses up to 75 mg once per day and 50 mg twice per day. The drug was generally well-tolerated.
- ATHX-105 had no clinically significant effects on heart-rate, blood pressure, or EKG parameters at any dose. The drug had no clinically significant effects on any hematology or clinical chemistry parameters at any dose.
"Based on these favorable results, we intend to continue with our plans and activities for initiating a Phase 2 study later this year," Van Bokkelen concluded.