Low levels of endogenous anti-PC identified as a novel risk factor for vein bypass graft failure and cardiovascular complications in PAD patients

Sep 29, 2016

Copenhagen September 29, 2016 Professor Michael Sobel, vascular surgeon at University of Washington in Seattle, USA presents new data from a prospective, observational study of 142 patients with peripheral artery disease (PAD) undergoing vein bypass at the at the annual meeting of ESVS (European Society of Vascular Surgeons) in Copenhagen. The primary outcome of this study was the loss of primary patency in the intervened blood vessel, and secondary endpoint was a composite of vessel failure, heart attack and stroke.

The study concludes that low levels of the naturally occurring anti-PC (endogenous antibodies towards phosphorylcholine) are linked with vein bypass graft failure, and that high anti-PC levels seems to be protective. The beneficial effects of anti-PC are suggested to be mediated by the anti-inflammatory actions, which are thought to quench the inflammatory effects of the exposed PC in damaged vascular cells. This novel biological mediator may be a useful marker to identify patients at higher risk of graft failure, and offers the potential for novel, directed therapies for vascular inflammation and its serious consequences. Endogenous IgM anti-PC was measured in blood samples from the patients using CVDefine® kit from Athera Biotechnologies.

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. Vein graft intervention 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.

The development costs for Athera’s lead product candidate are co-financed by the EU FP7 program, within the project CARDIMMUN.

For more information, contact: Carina Schmidt, CEO, Athera Biotechnologies AB Phone: +46 (0)76 1938 190, email:c.schmidt@athera.se

Athera presents positive First-in-Patient data with their new antibody against immunovascular disease at ESVS

Sep 28, 2016

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 IIa 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.”

The development costs for Athera’s lead product candidate are co-financed by the EU FP7 program, within the project CARDIMMUN.

For more information, contact: Carina Schmidt, CEO, Athera Biotechnologies AB Phone: +46 (0)76 1938 190, email:c.schmidt@athera.se

Athera Biotechnologies completes First-in-Patient Study with new antibody against immunovascular disease

Aug 11, 2016

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.”

The development costs for Athera’s lead product candidate are co-financed by the EU FP7 program, within the project CARDIMMUN.

For more information, contact: Carina Schmidt, CEO, Athera Biotechnologies AB Phone: +46 (0)76 1938 190, email: c.schmidt@athera.se

Athera initiates Phase I trial with its fully human antibody PC-mAb

Okt 21, 2014

Athera initiates Phase I trial with its fully human antibody PC-mAb
Oct 21, 2014.

STOCKHOLM, SWEDEN – October 21, 2014. Athera Biotechnologies AB, a Karolinska Development
AB portfolio company, today 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.”

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.

EU grants EUR 6m to the clinical development of Athera´s cardiovascular disease antibody therapy

Jun 17, 2013

June 17, 2013. Future development costs of its fully human antibody PC-mAb up until proof-of-concept will be co-funded by the European Union’s Seventh Framework Programme for Research (FP7) through a collaborative research grant. Karolinska Development AB owns 65% of Athera Biotechnologies AB. Athera’s fully human monoclonal antibody PC-mAb is targeting phosphorylcholine and is being developed for the treatment of patients with an increased risk of atherosclerosis related cardiovascular events and death. This includes myocardial infarction patients and patients with peripheral arterial disease undergoing vein graft surgery. The EUR 6m grant has been provided to the CARDIMMUN consortium, consisting of Athera, Leiden University Medical Center (LUMC), Turku PET Center (Turku University), Clinical Trial Consultants (CTC) and Smerud Medical Research. The project has a total budget of nearly EUR 8m and will be running over three years, focusing on key preclinical activities and clinical trials aimed at demonstrating proof-of-concept of this new cardiovascular treatment. LUMC is the project coordinator and will be leading the project together with Athera.