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news.Aeolus Pharmaceuticals, a developer of a potential new class of disease-modifying compounds, has obtained promising interim results for its phase I study evaluating AEOL 10150 in amyotrophic lateral sclerosis.
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The study is designed to evaluate the safety, tolerability and pharmacokinetics of single doses of up to six levels of AEOL 10150 in patients diagnosed with amyotrophic lateral sclerosis (ALS or Lou Gehrig’s disease), the most common motor neuron disease.
Based upon the interim analysis, it was concluded that single doses of AEOL 10150 ranging from 3mg to 30mg were tolerated as well as placebo. In addition, no serious adverse events were reported. The most frequently reported adverse events were injection site reactions, followed by dizziness and headache.
Based upon preclinical data, the presumed efficacious dose of AEOL 10150 in humans for the possible treatment of ALS is 3mg to 10mg.
“We are very optimistic that the phase I single dose study of AEOL 10150 is progressing as planned,” noted Richard Burgoon, Aeolus’ CEO. “The fact that the data to date indicate that we are able to dose ALS patients at least three to ten times above the presumed efficacious dose is very encouraging with respect to our planned multiple-dose study of AEOL 10150 in ALS patients.”
The results from the single-dose study are also expected to be used for the design of a phase II efficacy study of AEOL 10150 in stroke patients.