Aeolus Pharmaceuticals announced it met its primary endpoint for a phase 1 ascending dose escalation study.
Aeolus Pharmaceuticals (OTCQB:AOLS) announced it met its primary endpoint for a phase 1 ascending dose escalation study with AEOL 10150.
As quoted in the press release:
Aeolus plans to submit the final study report to the FDA along with a protocol for dosing up to 200 mg and 7-day multiple ascending dosing shortly.
In addition to demonstrating that the new formulation of AEOL 10150 was safe and well tolerated in healthy subjects, the study provided pharmacokinetic (“PK”) and pharmacodynamic data for the calculation of Human Equivalent Doses (“HED”) based on optimal efficacy seen in Lung Acute Radiation Syndrome (“Lung-ARS”), sulfur mustard and soman gas animal studies. Based on these data, the HED for sulfur mustard and soman gas is estimated to be 40 to 50 mg and the HED for Lung-ARS is estimated to be 75 to 125 mg. PK data from the multiple dose study will confirm the estimated doses based on modeling of the single dose PK.