Athera Initiates Phase I Trial with its Fully Human Antibody PC-mAb
Athera Biotechnologies AB has announced that first dosing of healthy volunteers has been done in a Phase I study of its fully human antibody PC-mAb. This lead product candidate targets the inflammatory component of cardiovascular disease, where current therapies are considered to be inadequate.
“We are pleased to have executed our plans in a very timely manner and are looking forward to the results from this important first clinical trial with our PC-mAb” says Carina Schmidt, CEO of Athera. “This is a key achievement for the EU FP7 project CARDIMMUN, aiming to generate proof-of-activity data for PC-mAb.”
“I am delighted to see this pharmaceutical project for such life threatening conditions leaving the lab benches to enter clinical trials”, says Bruno Lucidi, CEO of Karolinska Development.
Athera’s fully human monoclonal antibody PC-mAb is intended for the treatment of patients with cardiovascular disease, who are at an increased risk of secondary events and death. It is known from previous published studies that low plasma levels of endogenous antibodies against phosphorylcholine (anti-PC) are linked to poor prognosis in acute heart attack patients, as well as in patients with peripheral arterial disease undergoing vein graft surgery.
The current Phase I study will include up to 48 healthy volunteers in a single ascending dose protocol with safety outcome measures and is performed in Uppsala by CTC Clinical Trial Consultants AB.
The development costs for Athera’s lead product candidate are co-financed by the EU FP7 program, within the project CARDIMMUN.