Aeolus Announces Optimistic AEOL 10150 Phase I Trial Interim Results
Aeolus Pharmaceuticals has announced interim results for its Phase I, escalating single-dose study to evaluate the safety, tolerability and pharmacokinetics of AEOL 10150 administered by subcutaneous injection in patients with amyotrophic lateral sclerosis (ALS).
ALS, the most common motor neuron disease, results from progressive degeneration of both upper and lower motor neurons and is usually fatal within five years of symptom onset. The study is designed to evaluate single doses of up to six levels of AEOL 10150: 3, 12, 30, 45, 60, and 75 mg in four to five patients diagnosed with ALS (per dose group, three or four receiving AEOL 10150 and one receiving placebo).
The interim report summarizes the findings from the first three groups of patients (3, 12 and 30 mg). Each dose group was conducted at a separate clinical center. Based upon the interim analysis, it was concluded that single doses of AEOL 10150 ranging from 3 mg to 30 mg were tolerated as well as placebo. In addition, no serious adverse events were reported.
Based upon preclinical data, the presumed efficacious dose of AEOL 10150 in humans for the possible treatment of ALS is 3-10 mg. The most frequently reported adverse events were injection site reactions, followed by dizziness and headache. Adverse events were primarily mild in severity, and approximately one-half of the events were considered to have a possible relationship to the study medication. In addition, no clinically meaningful findings were noted in the safety laboratory, vital sign, UPDRS, functional ALS, or ECG data.