Exhibit 99.1
NewAmsterdam Pharma Presents Additional Data from Pivotal Phase 3 BROOKLYN Clinical Trial Evaluating
Obicetrapib in Patients with Heterozygous Familial Hypercholesterolemia at AHA Scientific Sessions 2024
– Met primary endpoint with LDL-C mean reduction versus placebo of 36.3% at day 84 and 41.5% at day 365 –
– Lp(a) mean reduction versus placebo of 45.9% at day 84 and 54.3% at day 365 –
– Total LDL-P mean reduction versus placebo of 52.5% at day 180, with small LDL-P reduction of 102.4% –
– Safety results comparable to placebo –
Naarden, the Netherlands and Miami, USA; November 18, 2024 – NewAmsterdam Pharma Company N.V. (Nasdaq: NAMS or “NewAmsterdam” or the “Company”), a late-stage, clinical biopharmaceutical company developing oral, non-statin medicines for patients at risk of cardiovascular disease (“CVD”) with elevated low-density lipoprotein cholesterol (“LDL-C”), for whom existing therapies are not sufficiently effective or well-tolerated, today announced additional results from the Company’s Phase 3 BROOKLYN clinical trial (NCT05425745) evaluating obicetrapib in adult patients with heterozygous familial hypercholesterolemia (“HeFH”), whose LDL-C is not adequately controlled, despite being on maximally tolerated lipid-lowering therapy. The data were presented today in an oral late-breaker presentation at the American Heart Association (AHA) Scientific Sessions.
“We believe the additional data presented today underscore obicetrapib’s potential to significantly reduce not only LDL-C but also Lp(a), LDL particles, both total and small, along with several other biomarkers in HeFH patients when compared to treatment with placebo. Within the HeFH patient community, it is common for patients to be on multiple lipid-lowering therapies, and given the efficacy and safety profile observed to date, we believe obicetrapib has the potential, if approved, to provide physicians with a new tool to address unmet need in these patients.” said Stephen Nicholls, M.B.B.S., Ph.D., Director, Monash Victorian Heart Institute and Professor of Cardiology, Monash University.
“Despite the availability of lipid lowering therapies, CVD risk remains high and many people suffering from HeFH fail to meet their target cholesterol levels. We believe these additional results from the BROOKLYN pivotal trial further highlight obicetrapib’s potential to meaningfully reduce LDL-C, while also significantly improving additional CVD risk parameters including Lp(a), non- HDL-C, ApoB, and HDL-C,” said Michael Davidson, M.D., Chief Executive Officer of NewAmsterdam. “Together with the supportive data generated to date, these results reinforce our belief that, if approved, obicetrapib has the potential to meaningfully improve treatment for CVD patients worldwide. We look forward to building on these results with topline data from our TANDEM and BROADWAY studies expected in the fourth quarter of 2024.”
Phase 3 BROOKLYN Trial Results
The BROOKLYN trial met its primary endpoint, achieving an LS mean reduction of 36.3% (p < 0.0001) compared to placebo at day 84, which was sustained at day 365 with an LS mean LDL-C reduction of 41.5% (p < 0.0001). Secondary efficacy endpoints, including lipoprotein(a) (“Lp(a)”), which was 45.9% (p<0.0001) compared to placebo at day 84 and 54.3% (p=0.16) at day 365, apolipoprotein B (“ApoB”), high-density lipoprotein cholesterol (“HDL-C”) and non-HDL-C met statistical significance and results were consistent with data reported from NewAmsterdam’s prior clinical trials. The p-value for the LS mean for all secondary endpoints compared to placebo was <0.0001 following 84 days of treatment with obicetrapib.
| | | | | | | | | | | | | | | | |
| | % LS mean change from baseline | | | Obicetrapib LS mean % | | | | |
| | Placebo (n=118) | | | Obicetrapib (n=236) | | | change compared to placebo | | | p-value | |
LDL-C | | | 0.3 | % | | | -36.1 | % | | | -36.3 | % | | | <0.0001 | |
Lp(a) | | | 10.5 | % | | | -35.4 | % | | | -45.9 | % | | | <0.0001 | |
Non-HDL-C | | | 2.8 | % | | | -31.6 | % | | | -34.5 | % | | | <0.0001 | |
ApoB | | | 2.9 | % | | | -21.5 | % | | | -24.4 | % | | | <0.0001 | |
Total LDL particles | | | 10.7 | % | | | -41.8 | % | | | -52.5 | % | | | <0.0001 | |
Small LDL particles | | | 32.4 | % | | | -70.0 | % | | | -102.4 | % | | | <0.0001 | |
HDL-C | | | 1.3 | % | | | 140.0 | % | | | 138.7 | % | | | <0.0001 | |
Note: As of day 84, except for particle data as of day 180