NewAmsterdam Pharma Company N.V. Ordinary Shares 12th Annual Cantor Fitzgerald Global Healthcare Conference
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Welcome everyone. We will get going on the next session. I am Steve Seedhouse with the Cantor Biotech team, and it really is a privilege for me to welcome our next participating company at our global healthcare conference. This is NewAmsterdam Pharma, and I am joined on stage, of course, by CFO Ian Somaiya. Ian, thanks so much for being here. Exciting time for the company and the field, and looking forward to the conversation, of course.
Always. I am sure you say that about all the companies that you host.
But especially about this one. As a sell-side analyst that learned from you in your time on the sell side, Ian, I can appreciate these moments in my career coming full circle and sitting on the stage with you here. It really is a pleasure. Maybe just given some of the recent developments in the field and the value proposition for obicetrapib as well, you have articulated, including at your recent Analyst Day. Just how you feeling about the competitive positioning and strategic positioning of the company and of obi as you approach really a key data readout towards the end of the year?
Yeah. No, we continue to feel really good about it. It is rare to have a drug that does so much, right? As we think about the benefits of obicetrapib and what we have been able to generate from a data standpoint, what we have learned, the starting point is obviously LDL. We are able to reduce LDL by 35% to 40% with the monotherapy, and the benefit reaches above 50% with the fixed dose combination. Importantly, what does that mean? It gets patients to goal, and that is really what matters to patients. To have it in a product form, in a drug that you can take once a day as a pill, with a very manageable safety profile, in a patient population that has many things that they are dealing with, there are many treatments that they are on, convenience matters, safety matters.
Safety matters to the prescriber base when we think about clinicians, vast majority of whom are primary care physicians. To simplify their practice and their experience while knowing that their patient's LDL will get to goal, and then also acknowledging that these patients have other comorbidities. The data that we generated through BROADWAY and through BROOKLYN clearly indicated that we are able to reduce the rate of nuance of diabetes. We are able to improve kidney function. We are obviously able to reduce Lp(a) by a meaningful amount, and also virtually eliminate small LDL particles, which represent residual risk in patients with elevated LDL. There is a lot to obicetrapib that we have shared. As a result, from a positioning standpoint, first and foremost, as we think about the branded therapies that are out there today and ones in development, we are the only CETP inhibitor.
As the comparison to other drugs and the comparisons amongst those other drugs is really limited to LDL.
Revisiting the recent Analyst Day and just sort of circling back on some of the key focus areas of that, because they are obviously important for understanding the value proposition, but really handicapping, I guess, probability of success and various scenarios of the interim analysis of the ongoing CVOT PREVAIL that we will get first quarter of next year, the results of, and that will be completed towards the end of this year. One of the details that you have spoken to a lot as a company is the blinded analysis that you conducted through year one. We have seen that data in the investment community through year two at that fixed time point, which we have not seen, but which you have spoken qualitatively to, and I might ask you to do that again.
Yeah What is it you are seeing?
Do you continue to sort of follow this blinded data, and really how are you interpreting it, and what is it telling you about?
Yeah obi? We've shared quite a bit with you.
The importance of the one-year data really couldn't be overstated because we had a very unique vantage point. This was the foresight that Michael and John had when setting up the company and designing the overall clinical program for obicetrapib, which was to design BROADWAY to be a mini PREVAIL, to be our sort of mini outcome study. Having the BROADWAY data and the 21% MACE reduction that we reported, now almost two years ago, was a good proxy, a good lens through a look at the PREVAIL dataset and what we were observing on a blinded basis. That's something we shared. When you look at the blinded PREVAIL data and superimpose it on the re-blinded BROADWAY data, those two lines are right on top of each other.
It's not only that the overall MACE for event rates are tracking on top of each other for those two trials, it's also the individual events were tracking in line with what we saw in BROADWAY. As we take that dataset and then move to year two, the observation that we shared with the investment community is those rates have continued to decline. There is a general expectation for decay in CV outcome studies, so year two rates are lower than year one, and subsequent years follows that trend. What we have seen is an event rate that's lower than what we would have expected, and also lower than what we have seen with other contemporary studies. It's an encouraging sign, but we all know the value of analyzing blinded data, that the proof in the pudding is always when you unblind these results.
Fortunately, the wait is not that long now, and we're excited about next year.
I think one of the factors that you've, I think, had to answer a lot of questions about that could be confounding that type of analysis is this sort of drop-ins.
Right back evolving therapeutic landscape with GLPs in particular.
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