Aeolus Pharmaceuticals Reports Safety Findings on ALS Drug Candidate

Aeolus Pharmaceuticals has announced the successful completion of the analysis of results from its Phase I multiple-dose study of AEOL 10150 (Study 102). The clinical direction for AEOL 10150 is currently under consideration, with the most likely targets for an efficacy study being a protector of healthy cells in radiation therapy in lung cancer and/or head and neck cancer and in amyotrophic lateral sclerosis (ALS).

Study 102 was a double-blind, randomized, placebo-controlled clinical study to assess the safety, tolerability and pharmacokinetic profile of three doses of AEOL 10150 administered by subcutaneous injection or infusion in patients with ALS. Three groups of six subjects were studied. Each subject in the first two cohorts received injections of AEOL 10150 or placebo for six days followed by a single injection on the seventh day for a total of 13 injections. In the first cohort each injection was 40 mg, and in the second cohort each injection was 60 mg.

There were two dosing modifications in the third cohort. First, the dosage was changed from a total fixed daily dose to a weight-dependent dose to ensure that each subject received the same dose irrespective of weight. Second, the method of subcutaneous compound delivery was changed from subcutaneous administration via needle and syringe to continuous subcutaneous delivery via infusion cannula. Subjects in the third cohort received a daily dose of 2 mg/kg delivered by osmotic infusion pump over 24 hours for 6.5 days.

Overall, the results showed that AEOL 10150 at doses up to 2 mg/kg/day was safe and well tolerated with an excellent pharmacokinetic profile in ALS subjects. All subjects completed the study. There were no serious or clinically significant adverse events. Mild decreases in sitting systolic and diastolic blood pressure were more frequent in the AEOL 10150 treatment groups than in the placebo group and were greatest in the 2-mg/kg/day group. Cutaneous observations, consistent with injection/infusion site reactions, were the most common adverse events.