Promising Clinical Trials
and Excellent Patent Protection
Due to its new and unique mechanism of action, ATH3G10 has the potential to become a First-in-Class therapeutic antibody for broad use in cardiovascular 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-concept study, focus may include indications such as heart failure, peripheral artery disease (PAD), and AV (arteriovenous) access dysfunction in dialysis patients.
Ongoing Proof-of-Concept study in Heart Failure
The company’s lead program is a Proof-of-Concept study (Phase 2) for high risk myocardial infarction patients. The primary endpoint is change in end-diastolic volume (measured by MRI), a surrogate endpoint for heart failure development. Other efficacy measures, clinical endpoints, biomarkers as well as safety and tolerability will be tested. Heart Failure is a growing problem worldwide, affecting more than 26 million people around the world. Heart Failure can be defined as the sudden or gradual onset of signs or symptoms of heart failure, resulting in a need for urgent therapy or hospitalization. It is a severe condition and the 5-year mortality in systolic heart failure is approximately 50%, which is worse than most cancers.
Completed clinical studies
Safety shown in first-in-human study
A double-blind phase 1a study in 48 healthy volunteers, randomized to a single administration of ATH3G10 or placebo, was initiated in 2014 and positive safety data were reported from the study. Additionally, ATH3G10 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 ATH3G10 or placebo. Conclusions from this Phase 1b study in PAD patients were positive, showing good safety and tolerability, as well as pharmacokinetic 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
A Phase 1 multiple dosing study in healthy volunteers was completed in 2017, as a preparation for future clinical studies including longer treatment with once monthly dosing. Positive safety and pharmacokinetics data provided continued support for further clinical development with repeated once-monthly administrations.
Trial to assess effects of longterm
treatment with ATH3G10 on arterial inflammation
A proof-of-mechanism Phase 2a study to assess the effects of longer treatment on arterial inflammation in individuals with very high levels of Lp(a), a plasma lipoprotein with high capacity to carry the pro-inflammatory target for ATH3G10, was started in 2017. Athera decided to close the study in 2018, and review of data led to the conclusion that subcutaneous dosing is advocated for repeated dosing in chronic conditions with individuals with high Lp(a). This development strategy is now pursued by Athera, while the intravenous formulation is used for short term treatments.
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 future products. Athera has general patent protection regarding the use of anti-PC for the treatment of cardiovascular disease to at least 2025. The lead anti-inflammatory antibody, ATH3G10, has key patent protection to at least 2032 (2034 in USA).