Urgent unmet need

Cardiovascular Diseases

Cause of death globally
Of all disease-caused deaths globally
Patients worldwide with clinically-significant ASCVD requiring treatment
CVD patients in the US
CVD patients in China
CVD patients in the EU
US Market
Biologics License Application (BLA) to the Food and Drug Administration (FDA) is planned in 1H 2024.
China Market
Hasten has obtained rights to develop and commercialize lerodalcibep and will be responsible for regulatory approval in these territories
EU Market
Currently searching for and reviewing regional partners for local development, approval, and commercialization


LDL-C is a clinically validated risk factor for atherosclerotic cardiovascular disease (CVD).  Atherosclerosis, fatty build up in the arteries supplying blood to the heart, brain and legs, leads to CVD which includes heart attacks, angina, heart failure, stroke and peripheral arterial disease (PAD).  CVD is globally still the leading cause of morbidity and mortality and continues to grow due to aging populations, increasing obesity and diabetes.  It is no longer just a disease found in westernized, affluent societies but is now a major concern, and the leading cause of death, in rapidly westernizing countries such as India and China.  CVD is projected to result in more than 22 million deaths over the next 15 years.

Over the last 30 years, mostly since the introduction of statins, large reductions in all types of CVD events and death have been well established by numerous well-controlled trials.   Studies have also shown that further LDL-C reductions in people already on statins and other LDL-C lowering drugs achieve even greater reductions in CVD events with a new class of therapies called PCSK9 inhibitors.

The data generated over the last 30 years strongly supports an accepted mathematical relationship for drugs like statins, ezetimibe and PCSK9 inhibitors which all lower LDL by increasing its removal from the blood stream: for every 40 mg/dL reduction in LDL-C there is a 22% decrease in CVD events in the next 2 to 3 year period.  Furthermore, studies show that this reduction in risk increases the longer the LDL-C remains decreased.

Based on cardiovascular outcome trials (CVOTs), stringent LDL-C guidelines are now harmonized between the US, Europe and Asia.  For the majority of ASCVD patients who fail to meet LDL-C goals on maximally tolerated statins (or for statin-intolerant patients), the PCSK9 class is recommended / accepted as adjunct therapy.  


Proprotein convertase subtilisin/kexin 9 (PCSK9), which is synthesized primarily in the liver, enters the circulation, where it binds to hepatic low-density lipoprotein (LDL) receptors and targets them for degradation.  This process reduces the capacity of the liver to bind and remove LDL cholesterol and results in increased LDL cholesterol levels.

Lerodalcibep  binds specifically to PCSK9 in the blood stream and blocks it from attaching to the LDL receptors, increasing LDL receptor recycling, increasing LDL-C clearance, and lowering LDL-C.

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