Promising Clinical Trials
and Excellent Patent Protection
Due to its new and unique mechanism of action for treatment of medical indications, PC-mAb has the potential to become a First-in-Class therapeutic antibody for broad use in vascular disease. Athera is therefore planning parallel trials for several possible indications where medical need, scientific ground and commercial viability support further development. Based on a positive report from the current Phase 2a proof-of-mechanism study, focus may include indications such as peripheral artery disease (PAD), heart failure, and AV (arteriovenous) access dysfunction in dialysis patients.
Safety shown in first-in-human study
A double-blind phase 1a study in 48 healthy volunteers, randomized to a single administration of PC-mAb or placebo, was initiated in 2014 and positive safety data were reported from the study. Additionally, PC-mAb showed the desired properties for once-monthly administration.
Pharmacokinetics confirmed in patients
The phase 1b study in patients with peripheral artery disease (PAD) began 2015 at Karolinska University Hospital. 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 causes extensive pain also at rest, leading to further morbidity. The risk for severe events such as heart attack and stroke is high, as well as the risk for amputation of the affected limbs. Twelve patients received a single dose of PC-mAb or placebo. 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 results were presented at the 30th Annual Meeting of the European Society of Vascular Surgeons in Copenhagen, 28–30 September, 2016.
Positive safety and pharmacokinetics data
in multiple dosing trial supports further development
A Phase 1 multiple dosing study in healthy volunteers was initiated in 2017, as a preparation for longer treatment with once monthly dosing in the planned Phase 2a study. Positive safety and pharmacokinetics data provides continued support for further clinical development with once-monthly administrations.
Trial started to assess effects of
PC-mAb treatment on arterial inflammation
Screening has started for a Phase 2a prospective, double-blind, randomized, placebo-controlled multicenter study to investigate the effects of treatment with PC-mAb. The study population consists of individuals at least 50 years old with elevated levels of Lp(a), the plasma lipoprotein with high capacity to carry phosphorylcholine, PC, the pro-inflammatory target for PC-mAb ( Clinical Trial Consultants Study 144 ).
The primary objective of the study is to assess the effects of PC-mAb dosing with once monthly intravenous injections on monocyte function ex vivo. Secondarily, the study aims to assess the functional effects on arterial inflammation in vivo and on arterial stiffness, as well as safety and tolerability of PC-mAb. The study sites include AMC Amsterdam Medical Center, the Netherlands, and CTC Clinical Trials Consultants in Uppsala, Sweden.
A comprehensive patent portfolio
The strategy of Athera is to have strong patent protection for our current and future product candidates. This strategy is global, but at the same time focusing on those markets that are judged to be most important for the various patent families. Athera has general patent protection regarding the use of anti-PC for the treatment of cardiovascular disease to at least 2025. The immunovascular antibody, PC-mAb, has key patent protection to at least 2032.