Can you provide an introduction to NewAmsterdam and its current projects?
NewAmsterdam is a cardiovascular company focused on developing obicetrapib, a novel class of LDL cholesterol-lowering drugs. We are currently in the mid stages of Phase 3 trials, aiming to complete them in the second half of 2024. Our goal is to launch the drug after the completion of a cardiovascular outcome trial which we expect to be completed in late 2026. Obicetrapib represents a significant advancement in the treatment of cardiovascular diseases, which remain a leading cause of death worldwide.
How critical is the fight against high cholesterol in combating heart diseases?
We had been making progress in reducing risks associated with cardiovascular disease until a recent reversal in heart disease deaths. This uptick, which began around 2013, highlights the need for better therapies to lower LDL cholesterol, a highly modifiable risk factor.
Today, more than 70% of patients with high cholesterol are not meeting their treatment goals.
Lowering LDL is crucial, as evidence strongly suggests it can prevent heart disease. We believe that more effective oral therapies, like obicetrapib, will substantially reduce cardiovascular risk by helping more patients reach their risk based LDL goals. Remember, many people cannot reach their LDL goals with statins alone. Our focus is to bring innovative treatments that can complement or replace existing statins, especially for patients who find them inadequate or intolerable.
How was obicetrapib developed, and how does it work?
Obicetrapib is a CETP inhibitor, targeting a protein that transfers cholesterol from HDL to LDL. This inhibition lowers LDL particles, thereby with the hope of reducing heart disease risk. The genesis of obicetrapib is rooted in the understanding that animals without CETP, like dogs and rats, do not develop atherosclerosis. Human genomics studies also show that lower CETP activity correlates with reduced heart disease. We have conducted five Phase 2 trials demonstrating that obicetrapib lowers LDL cholesterol by about 40 to 50% on top of patients’ existing LDL therapies such as high intensity statins. In addition, obicetrapib has been shown to be safe and well tolerated including no increase in blood pressure or muscle related side effects and is conveniently dosed at one pill once a day with or without food.
Can you share your confidence in the Phase 3 clinical trials for obicetrapib and the details of your deal with Menarini?
The correlation between lowering LDL cholesterol and reducing cardiovascular (CV) risk is well-established. Our Phase 2 studies showed obicetrapib reduced LDL-C by almost half, and more than 70% of patients reached LDL-C goals when added to a high intensity statin. Our Phase 3 trials are designed to optimize CV benefit by targeting high baseline LDL levels and significant cholesterol reduction over a sustained period. This approach, coupled with the latest findings in LDL-C lowering, positions us to accurately determine the drug's benefits. As for our collaboration with Menarini, it's a strategic decision to address the challenges of cardiovascular biotech, which requires substantial patient studies, time, and capital. Menarini provides us with the necessary resources and expertise to commercialize in the complex European market.
Do you have any estimation as to when these drugs will be out in the market?
We anticipate obicetrapib’s first approval in 2026, with Europe potentially being the first region for its launch. The U.S. market will follow, pending the completion of our outcomes study. The study's focus on demonstrating reductions in major adverse cardiovascular events will provide increased evidence of obicetrapib’s clinical benefit to support the drug's launch. Our drug stands out for its efficacy in lowering LDL and its tolerability in an oral formulation, aiming to address the gaps left by other LDL-lowering drugs. Unlike some previous launches in this category, we plan to introduce obicetrapib in the U.S. with outcomes data already demonstrating its benefits, as there remains skepticism about LDL-lowering mechanisms without specific outcome studies.
Why do you think there is a smaller portion of biotech firms working on cardiovascular diseases?
The intrinsic nature of cardiovascular diseases, being slow and progressive, necessitates large-scale, long-term studies to demonstrate benefits, which is inherently different from conditions like cancer. This aspect of heart disease demands extensive patient studies and significant time investment. Additionally, we in the academic and medical community have set very high standards for establishing new therapies' benefits, particularly for LDL-lowering treatments. We aim to reach a consensus where LDL-lowering is treated on par with managing other risk factors like blood pressure. However, overcoming these hurdles is a broader challenge beyond NewAmsterdam's scope. Our goal is to make significant contributions in providing effective treatment for cardiovascular diseases and influence the academic perspective on managing LDL levels.
Can you tell us about the future plans of NewAmsterdam, particularly regarding the second drug in your pipeline?
In addition to obicetrapib, we're developing a fixed-dose combination with ezetimibe, a known and effective cholesterol-lowering drug. This combination, in our Phase 2 study, has shown to lower LDL by over 60%, which we believe are due to complementary mechanisms between the two drugs, making it potentially the most effective non-statin oral drug for this purpose. We plan to launch both the monotherapy and the fixed-dose combination simultaneously. Our strategy includes completing outcome studies before the launch to ensure broad access and to overcome reimbursement challenges. Learning from past experiences in the pharmaceutical industry, we are keen on ensuring that our therapies are widely accessible upon their introduction to the market.
What is your general outlook on the future of the pharma industry, particularly with advancements in genomics and AI?
Advancements in genomics have been instrumental in validating drug targets and spurring novel therapies. For NewAmsterdam, genomic validation was a key part of our investment thesis. While the impact of AI in drug development is still unfolding, its ability to provide access to extensive information and foster global communication has been invaluable. For example, our research into Alzheimer's disease and its potential for improvement or prevention with our drug was significantly aided by AI-enabled literature searches. We're also exploring other benefits of obicetrapib, such as preventing the onset of diabetes, which was guided by genomic insights. The interconnectedness of various health issues and the role of genomics and AI in uncovering these connections underscore the exciting and dynamic nature of the pharmaceutical industry's future.
