NewAmsterdam Pharma is a company established to tackle a health problem, one that affects over an estimated 30 million people worldwide. People with high levels of low-density lipoprotein cholesterol (LDL-C). It is an issue that is only going to become more pressing if unmet.
“The population is ageing, and the goals to bring LDL-C down are now more aggressive,” explains Dr Michael Davidson, CEO of NewAmsterdam Pharma. “The need has become more intense as evidence continues to support the idea that lower is better. It is not a difficult sell for investors to understand.”
While the need is there, previous attempts to bring LDL-C down with pharmaceuticals have faced drawbacks.
“Other drugs launched to lower LDL-C have not done well commercially, either because they are not that effective or they are very expensive and require injections,” Davidson says. “But we are developing a next-generation, oral, low-dose drug that has been observed to be well-tolerated and has positive efficacy signals in our clinical trials to date. Due to the expected low cost of goods, we expect we’ll be able to offer very flexible pricing if our product is approved for commercialization, potentially unlocking a lot of value and unmet needs with a therapy that meets the necessary criteria.”
That drug is obicetrapib, a novel, selective inhibitor that has been found to target the Cholesteryl Ester Transfer Protein (CETP). Clinical trials have shown it can significantly reduce LDL-C while also substantially increasing the beneficial high-density lipoprotein (HDL) cholesterol. The idea is that by transforming the ratio of ‘good’ versus ‘bad’ cholesterol in the body, obicetrapib could be a potentially transformative treatment for patients.
Putting the Team Together
Davidson has led the research into this project alongside his co-founder, John Kastelein, both of them well-known researchers, bringing a career’s worth of experience to bear.
“I am a cardiologist and lipidologist. This is my third biotech company. I have been in clinical research for 30 years with my co-founder John Kastelein,” Davidson says.
Davidson and Kastelein are supported by an elite team of researchers, and their combined experience.
“Our selling point is our team’s experience in drug development, and our track record,” Davidson points out. “We have had multiple successes. We now have not just a better drug for lowering cholesterol, but one that has been observed to lower LDL-C by over 50% in clinical trials to date and that is generally well tolerated. We also have a better clinical development program based on over a decade of learnings on conducting clinical trials. That has been our key investment thesis in why we believe we are going to be successful in bringing an important new drug to market.”
It is a team that Davidson has assembled throughout his entire career. This is his third biotech company, and its team is made up of talented individuals he has drawn from his previous companies.
“They are experienced, especially in this therapeutic area, and in this post-Covid time we have learned to allow talent to be more virtual,” Davidson says. “We can attract people from all over the world. We have people from the Amsterdam area, Florida, and New York. We can be geographically diverse in who we pick, we do not need to be focused on a set location.”
Of course, in pharmaceutical research, you need a laboratory, but as NewAmsterdam Pharma is undertaking a phase 3 global program, with clinical sites all over the world, it is able to work effectively with a disparate team.
“We maintain a company culture where we get together as regularly as we can, but people can work in their own offices,” adds Davidson. “It has made it efficient for us to hire the best people and maintain them with our funding. We have people who believe in this drug. It is a small team of 20 people, all of them highly effective in getting this phase 3 program executed on schedule.”
Getting Results
That wealth of experience is particularly useful as it means the company can draw on that knowledge to understand the best way to structure clinical trials for its drug.
“With cardiovascular studies, we know LDL-C is a major causal factor for heart disease. What is not as well understood is how much you need to lower LDL-C and the time it takes,” Davidson explains to us. “There is this misunderstanding about the percentage of LDL-C lowering versus absolute LDL-C lowering, as well as the necessary duration of treatment. You might not see the effective benefit of treatment until two to three years into the therapy. Unless you know those things from previous trials, you will see less benefit than you hoped for.”
It means that NewAmsterdam Pharma can draw up a better clinical profile for its drug, which will be important in determining how it is perceived by clinicians.
“The nature of the disease means you need large clinical trials and a significant amount of capital. It takes many years to get these drugs to patients, so you need large amounts of capital and investors who can be patient to really be successful in making a difference for patients,” Davidson says. “This is why you find very few cardio metabolic companies in this area.”
It is a challenge that NewAmsterdam Pharma has been proactive in overcoming, with a strategy that made use of a deSPAC and a related PIPE transaction.
“These have been out of favour of late, but we had an incredibly successful deSPAC and related PIPE,” says Davidson. “I think that it has been surprising to a lot of folks how successful we have been with our transactions, and it came down to the team itself, the drug and then the ability to raise enough funding which we believe will take us through to completion of our phase 3 trials.”
NewAmsterdam Pharma has also solved its financing issues thanks to an investor base willing to be patient over the long term to achieve value for themselves and the clinical community. And the investment is getting closer and closer to paying off.
“Right now, we’re in phase 3 trials, with complete enrolment expected in July of this year for two large LDL-C lowering trials called Broadway and Brooklyn,” Davidson tells us excitedly. “We expect to have our clinical readouts in 2024. The big value inflexion point comes at the end of 2026 when we expect to report data from our phase 3 cardiovascular outcomes trial which we hope will validate that our drug results in cardiovascular benefits. Once we get to that stage, we believe this will unlock a lot of value.”
That NewAmsterdam Pharma has raised all of its capital up-front means it can overcome some of the common pitfalls of businesses in this market.
“At this point, we don’t need to go back and raise more,” Davidson says. “We can push forward to the finish line.”
Dr Michael Davidson John Kastelein
CEO, NewAmsterdam Pharma Chief Scientific Officer, NewAmsterdam Pharma
