Press release -
Athera presents positive First-in-Patient data with their new antibody against immunovascular disease at ESVS
Copenhagen September 28, 2016 Athera Biotechnologies AB, a privately held biopharmaceutical company focused on developing a new antibody against immunovascular diseases, presents data from the first study in patients with peripheral artery disease (PAD) at the annual meeting of ESVS (European Society of Vascular Surgeons) in Copenhagen. Conclusions from this Phase 1b study in PAD patients were positive, showing good safety and tolerability, as well as antibody properties supporting once monthly dosing also in patients. The study, run at Karolinska University Hospital in Stockholm, included 12 patients receiving a single dose of Athera’s lead candidate PC-mAb or placebo.
Professor Gunnar Olsson, Chairman of the Board, said “The study data confirms that there are generally low levels of endogenous antibodies to phosphorylcholine, anti-PC, in PAD patients, indicating a window for reconstitution therapy with PC-mAb. We also noted that PAD patients have markedly reduced limb arterial dynamic functionality, which was an important observation for future clinical study designs. This really give a good base for succinct definitions of clinically relevant endpoints in the planned phase 2a study in this patient group.”
“We are very pleased to have reached this important milestone and to be able to report safety data supporting next development steps, efficacy trials with PC-mAb, said Athera CEO Carina Schmidt. “We think PC-mAb has significant potential to address unmet medical needs in PAD, but also in other immunovascular diseases, and this should represent a significant value for an industrial partner.”
For more information, contact: Carina Schmidt, CEO, Athera Biotechnologies AB Phone: +46 (0)76 1938 190, email:c.schmidt@athera.se
Topics
- Medical research
Categories
- athera
- athera biotechnologies
- clinical
- therapeutic antibody
- clinical trial
- immunovascular disease
- phase i
- revascularization
- vein graft bypass
- peripheral artery disease
- cardiovascular disease
About Athera Biotechnologies AB
The mission of Athera is to address the large unmet need for anti-inflammatory therapeutics in the treatment of immunovascular disease. Athera´s focus is on PC-mAb, a clinical stage biopharmaceutical program with block-buster potential. In addition, Athera has developed a biomarker and companion diagnostics product, CVDefine® kit. The biomarker could in the future be used for identification of patients that benefit from Athera’s novel therapeutics. PC-mAb provides an opportunity to address the need for improved secondary prevention after revascularization in severe PAD patients and reduce the associated risks for complications and new vascular disease events. 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. The risk for severe events like heart attack and stroke is high, as well as the risk for amputation of the affected limbs. Development of PC-mAb is co-funded by EU FP7 in the CARDIMMUN project. Major shareholders are Industrifonden, The Foundation for Baltic and East European Studies (Östersjöstiftelsen) and Linc AB.For more information: www.athera.se
