US-based biotechnology firm Aeolus Pharmaceuticals has initiated a Phase I clinical trial of an AEOL 10150 subcutaneous injection in healthy volunteers.
AEOL-10150 is designed to protect tissue from damage by inhibiting cell death, inflammation and fibrosis.
It is being developed as a treatment for the lung and delayed effects of acute radiation exposure (Lung-ARS), idiopathic pulmonary fibrosis (IPF) and as a combination with radiation therapy to treat solid tumours.
The open-label, single centre, dose-escalation Phase I trial will evaluate the safety, tolerability and pharmacokinetics of an escalating single dose of AEOL 10150.
Aeolus president and chief executive officer John McManus said: "The new formulation of AEOL 10150 has reduced the cost of the drug by approximately 90%, and the additional toxicology work cleared the way for testing in healthy subjects.
"This Phase I study will give us important safety and pharmacokinetic data that will allow us to accelerate and expand the development of AEOL 10150 in both large commercial and in biodefence indications that represent major unmet medical needs."
Throughout the trial, the firm intends to expand a safety database for AEOL 10150's new formulation, support its pre-emergency use authorisation application in Lung-ARS for IPF and radiation therapy indications, as well as a medical countermeasure for lung damage from exposure to sulfur mustard gas.
After the completion of the Phase I trial, Aeolus plans to initiate multiple dose studies in patients with IPF and cancer.
AEOL 10150 is being developed under a $118.4m advanced research and development contract with the Biomedical Advanced Research and Development Authority (BARDA).