FundsUp spoke with Marguerite Mersonides, an experienced pharmaceutical professional and CEO of Amplio Pharma, about their ambitious plans. She and the management team are responsible for strategic development and hire the expertise and capabilities of smaller companies and CROs (Contract Research Organizations) for practical implementation. Amplio Pharma is now seeking investors to further develop their innovations.
A Dutch version of this article can be read on the website of our partner: Emerce.
Could you briefly introduce yourself to the readers and tell us how you got here?
“My name is Marguerite Mersonides, and I am originally a pharmacist. With over 25 years of experience in the pharmaceutical industry, I have worked for both large and small pharmaceutical companies. About seven or eight years ago, I decided to follow my own path as a consultant, helping startup biotechs turn their ideas into projects that could lead to new drugs. During this work, together with two former colleagues, I saw a significant opportunity in the treatment of rheumatic patients. The first-line medication often used was far from effective, and we were convinced that we could identify the cause and develop a better solution. This led to the launch of our own development project.
After successful preclinical studies, we applied for a patent, which has since been granted. This gave us the confidence to establish a company, Amplio Pharma. The name ‘Amplio’ reflects our goal to improve underperforming drugs through our NovoBioMet technology platform, based on Modified Retention technology. Our platform focuses on increasing the effectiveness of drugs and reducing side effects for patients. A year ago, we met our first external investor, Libertatus Ergo Holding in Leiden, which resulted in the establishment of our company in the Netherlands. Since then, we have set up valuable collaborations with various universities and other Dutch companies to further develop our first clinical drug.”
How does the collaboration with these companies work? Is it a commercial partnership?
“We handle the strategic development and then hire the expertise and capabilities of those small companies. For example, we have hired a laboratory in Venlo to conduct Quality Chemistry (QC) for our clinical preparation under investigation. Additionally, we have hired a qualified person (freelancer) from Utrecht to ensure we comply with GMP regulations. We have also hired the pharmacy at the Leiden University Medical Center (LUMC) to produce our clinical preparation, and we are working with the Centre for Human Drug Research, a Phase 1 clinical research organization, to develop the planned clinical study with us. So, we have established these connections through good commercial collaborations. Simultaneously, we also work with professors in rheumatology at LUMC in Leiden and in analytical chemistry at AUMC in Amsterdam to discuss and develop more exploratory studies.
We have also contracted Key Opinion Leaders (KOLs) in the United States, who are rheumatologists with extensive experience in clinical studies in the specific disease area we are currently focusing on. In summary, Amplio Pharma is essentially a five-member management team of pharmaceutical industry veterans, including the three female founders, and we have mainly extended our operations to other CROs we hire and universities with whom we collaborate.”
Can you tell us more about Amplio Pharma?
“Having a chronic immune-mediated inflammatory disease like rheumatism has a significant impact on your life and on that of the more than 20 million patients worldwide. The medical research community has yet to find a cure for these diseases, and treatment has not advanced in decades. It is known that conventional methotrexate, the current first-line medication, is expelled too quickly from cells and tissues to be optimally effective.
At Amplio Pharma, we aim to solve this problem with our NovoBioMet technology. This works by adding the natural compound novobiocin, which acts as a pharmacokinetic booster to ensure that the actual drug methotrexate can be retained by the target cells and tissues, resulting in a much more effective treatment.
All components in our patented clinical drug product have been previously validated in human medicine, which translates to a lower development risk and a faster and more cost-effective development program. Research shows that the treatment’s effectiveness can be doubled.
Amplio Pharma’s solution has the potential to become the number one treatment choice for this large patient group. Therefore, the team is so dedicated to getting this candidate drug into the hands of the patients who need it. Our mission is to improve patients’ lives by preparing a cornerstone drug with an innovative, patented solution for the future.”
Have you already achieved promising results?
“Well, the business has been around since 2020, 2021. Before that, we were already operating under one of our own CROs, and over the past few years, we have conducted about 10 preclinical in vivo studies. These are part of our in-house intellectual property. Additionally, we have successfully navigated the submission of the invention and application of the NovoBioMet technology for the rheumatism drug MTX through the European and American patent offices, and we have been granted the patent. And since last year, with the first external investment of 350,000 euros, we have really started the clinical program. The clinical preparation we want to investigate has been produced at LUMC and placed in stability studies.
Moreover, with the CHDR, the University of Amsterdam, and our KOLs, we have set up the clinical study, the phase 1b study that we want to conduct, and we are now finalizing the clinical trial application dossier to submit it to the Dutch Medicines Evaluation Board and the local ethics committee, so that we can really carry out the study once we have raised the capital round.”
How do you plan to approach the market?
“We are not waiting until later to approach the market. We have already started! We began this process right after we had the NovoBioMet idea and filed the patent in the spring of 2017. About six months later, we started approaching the pharmaceutical industry with this idea and our plan to develop a new drug product that would fall within the first-line treatments for rheumatism. We discussed that with this new patented product, we could replace the current first-line treatment and asked if they would be interested in licensing or even fully acquiring the eventual production and commercialization of such a product. And if so, how far we needed to be in the development for such licensing or full acquisition. We approached quite a few companies, both in Europe and North America, to get a clear idea of what data these future partners would want to see in order to say: ‘This is something that interests us, and this is the point at which we want to take over Amplio Pharma’s candidate drug product.’ The answer was universal and clear: ‘Show that the NovoBioMet technology clearly improves efficacy in patients in a clinical phase 2 study.’
So, our intention is to develop this first NovoBioMet candidate until we have seen in patients that it is an improvement over standard methotrexate treatment. And once we have that data, which we can have about 36 months after we start the first clinical study, we will have reached the point where the pharmaceutical industry will take over from us. That is also the exit point for the current investors.”
Exciting! And you are raising funds now; can you tell us more about that?
“The current funding round is for 1.5 million euros, which we want to build into an investment consortium led largely by our first external investor, LEH. We have now secured about 750,000 euros. So, we are still looking for the other half. We intend to use that money to complete the first clinical phase and ensure that we have enough runway to close the next funding round successfully. We already have interest from the United States for that second round. They mainly want to see the first human data before committing. But that is what we want to do with the money: generate patient data that demonstrates that our idea is safe and shows promise in efficacy.”
Where do you ultimately hope to be?
“The vision of our company and the founders is to improve various drugs with our NovoBioMet Technology. We hope to achieve this by successfully bringing our first and, in our opinion, most promising candidate to market. This would allow us to generate sufficient revenue to finance further developments. We also hope that our investors will align with this vision, which stems from a desire to provide better first-line drugs and therapies to patients, their doctors, and society as a whole. As we all age and require more medications, it is important that these medicines are of the best possible quality. However, we come from the pharmaceutical industry and understand that it is not only driven by ideals.
Another important factor is economic reality. Is something economically viable? Is there a market for a drug? We have thoroughly calculated our first candidate. Regardless of the final reimbursement, the cost price ensures that the investment can be more than recouped. Within Europe and the US, there are about five million rheumatism patients, our total addressable market for that specific disease alone. At the moment, about 75 percent are treated with first-line drugs, within which our new product will fall.
In terms of revenue, that means that at a price point of, say, a thousand euros per patient per year, and that’s really at the low end of what such a drug product would yield annually, we’re already talking about billions. And if you calculate with the likely pricing, which is around 5,000 to 7,000 euros per person per year, there’s a significant multiple involved. That’s what makes it so interesting. When we started conversations with other larger pharmaceutical companies that will eventually take over the production and commercialization for us, they immediately saw that. That’s why there is interest.”
More information about Amplio Pharma for investors can be found here.