Athera Biotechnologies announces that first dosing in a multiple dosing study in healthy volunteers has been done with its fully human antibody PC-mAb, less than three weeks after regulatory authority approval.
“We are pleased to have executed our plans in such a timely manner and are looking forward to the results from this multiple dosing trial with our PC-mAb” says Carina Schmidt, CEO of Athera. “The study is a preparation for the longer treatment with once monthly dosing in the planned Phase 2a study with severe peripheral arterial disease patients.”
Peripheral arterial disease, PAD, is a chronic disease that severely restricts the mobility of the patients and therefore their quality of life. It affects about 5% in ages 45-50 and 19% in ages 85-90. With severe PAD the disease is causing extensive pain also at rest, leading to further morbidity. Revascularization is performed to restore blood flow to reduce pain and restore mobility for the patients. However, the risk for severe events like heart attack and stroke is still high, as well as the risk for amputation of the affected limb. PC-mAb is designed to mimic the anti-inflammatory role of endogenous antibodies against PC and act to support the immune response to vascular inflammation challenges and thereby reduce the risk for complications in these patients.