Stockholm August 11, 2016 Athera Biotechnologies AB, a privately held biopharmaceutical company focused on developing a new antibody against immunovascular diseases, reports that the first study in patients with peripheral artery disease (PAD) is now completed. Results will be presented at the ESVS (European Society of Vascular Surgeons) annual meeting in Copenhagen in September.
The completed Phase 1b study in PAD patients was initiated late 2015 at Karolinska University Hospital in Stockholm, and includes 12 patients receiving a single dose of Athera’s lead candidate PC-mAb or placebo. A First-in-Man study had successfully been completed earlier in 2015. The double-blinded Phase 1a study with 48 healthy volunteers, randomized to administration of PC-mAb or placebo, supported that the antibody was generally safe and well tolerated with no serious adverse events related to study drug administration, as well as having desired antibody properties for once-monthly administration.
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.
Professor Gunnar Olsson, Chairman of the Board, said “Prevention of complications in patients with severe PAD represents a large unmet medical need, since such complications are not uncommon and there is presently little to offer to reduce risk. PC-mAb represents a great opportunity to contribute to better treatment for these patients. Additionally, PC-mAb has significant potential to address unmet medical needs in other immunovascular diseases, and these indications should represent a significant value for a partner.”
“I am excited with the completion of this first patient study with our fully human antibody PC-mAb,”, said Athera CEO Carina Schmidt. “Athera is now pushing forward towards efficacy trials, hopefully together with an industrial partner.”
For more information, contact: Carina Schmidt, CEO, Athera Biotechnologies AB Phone: +46 (0)76 1938 190, email:c.schmidt@athera.se
The completed Phase 1b study in PAD patients was initiated late 2015 at Karolinska University Hospital in Stockholm, and includes 12 patients receiving a single dose of Athera’s lead candidate PC-mAb or placebo. A First-in-Man study had successfully been completed earlier in 2015. The double-blinded Phase 1a study with 48 healthy volunteers, randomized to administration of PC-mAb or placebo, supported that the antibody was generally safe and well tolerated with no serious adverse events related to study drug administration, as well as having desired antibody properties for once-monthly administration.
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.
Professor Gunnar Olsson, Chairman of the Board, said “Prevention of complications in patients with severe PAD represents a large unmet medical need, since such complications are not uncommon and there is presently little to offer to reduce risk. PC-mAb represents a great opportunity to contribute to better treatment for these patients. Additionally, PC-mAb has significant potential to address unmet medical needs in other immunovascular diseases, and these indications should represent a significant value for a partner.”
“I am excited with the completion of this first patient study with our fully human antibody PC-mAb,”, said Athera CEO Carina Schmidt. “Athera is now pushing forward towards efficacy trials, hopefully together with an industrial partner.”
For more information, contact: Carina Schmidt, CEO, Athera Biotechnologies AB Phone: +46 (0)76 1938 190, email:c.schmidt@athera.se
