- Achieved Primary Endpoint with Statistically Significant 45.8% Median Reduction in LDL-C (p < 0.0001) in patients treated with 10mg obicetrapib
- 29.7% Median Reduction in Apo B and 37.0% Median Reduction in non-HDL-C from Baseline (p < 0.0001) in patients treated with 10mg obicetrapib
- Favorable Safety and Tolerability Observed
- Data Enable PMDA Regulatory Path Aligned with Rest of World; Plan to Leverage Data from Ongoing Phase 3 BROOKLYN, BROADWAY and PREVAIL Trials to Support Potential Approval in Japan
- Management to Host Conference Call Today at 8:00 a.m. E.T.
Naarden, the Netherlands and Miami, USA; June 5, 2023 – NewAmsterdam Pharma Company N.V. (Nasdaq: NAMS or “NewAmsterdam” or the “Company”), a clinical-stage biopharmaceutical company developing oral, non-statin medicines for patients at high risk of cardiovascular disease (“CVD”) with residual elevation of low-density lipoprotein cholesterol (“LDL-C” or “LDL”), for whom existing therapies are not sufficiently effective or well-tolerated, today announced statistically significant and clinically meaningful topline results from the Phase 2b dose-finding trial of obicetrapib, the company’s oral, low-dose and once-daily cholesteryl ester transfer protein (“CETP”) inhibitor, as an adjunct to stable statin therapy in Japanese patients with dyslipidemia. Based on the results observed, NewAmsterdam plans to leverage data from the ongoing Phase 3 BROOKLYN, BROADWAY and PREVAIL clinical trials, if supportive, to pursue regulatory approval in Japan.
“Despite the availability of statins, elevated levels of LDL-C continue to pose a significant public health burden. A considerable number of patients fail to achieve sufficient LDL-C lowering on existing treatment options or are unable to access these therapies due to high costs,” said Mariko Harada-Shiba, M.D., Ph.D., Director at the Department of Molecular Innovation in Lipidology at Osaka Medical and Pharmaceutical University. “There are currently millions of people living with atherosclerotic cardiovascular disease (“ASCVD”) or heterozygous familial hypercholesterolemia (“HeFH”) in Japan. Like in other geographies, there is a significant unmet need for an oral therapy that can help many more patients achieve target LDL-C goals. Based on the data reported today, I believe incorporating obicetrapib, if approved, alongside statin therapy may emerge as a promising treatment approach, and I look forward to partnering with the NewAmsterdam team to advance obicetrapib’s development globally.”
Topline Data from the Phase 2b Japan Trial
"After announcing positive data from our ROSE2 trial at the National Lipid Association (“NLA”) Scientific Sessions this weekend, we are excited to report strong clinical results from the Phase 2b trial assessing obicetrapib in Japanese patients,” said Michael Davidson, M.D., Chief Executive Officer of NewAmsterdam. “We are particularly encouraged by the consistency of these results with data observed across our clinical program to-date, which reinforces our belief in obicetrapib as a potentially paradigm-changing medicine. Importantly, we believe these data enable us to pursue a regulatory strategy in Japan aligned with our efforts in the rest of the world and look forward to seeking global approval for obicetrapib, if the data from our three pivotal Phase 3 trials, BROOKLYN, BROADWAY and PREVAIL, is positive. With our operational expertise and a strong partner to support obicetrapib commercialization in Europe, if approved, we believe we are well positioned to significantly improve patient outcomes and to potentially transform healthcare for millions of people who are living with cardiometabolic diseases."
The Phase 2b trial was a placebo-controlled, double-blind, randomized, dose-finding trial to evaluate the efficacy, safety and tolerability of obicetrapib as an adjunct to stable statin therapy in Japanese patients. The trial enrolled 102 adult participants, who were randomized 1:1:1:1 to receive obicetrapib 2.5mg, 5mg, 10mg or placebo for a 56-day treatment period.
Patients treated with obicetrapib 2.5mg, 5mg, or 10mg, achieved a median reduction in LDL-C of 24.8%, 31.9%, and 45.8%, respectively, as compared to patients treated with placebo, who achieved a median reduction in LDL-C of 0.9%. In addition, patients treated with obicetrapib 10mg achieved a median reduction in apolipoprotein B (“Apo B”) of 29.7%, compared to a 1.2% reduction in patients treated with placebo, and a median reduction in non-high-density lipoprotein cholesterol (“non-HDL-C”) of 37.0%, as compared to a 0.4% reduction in patients treated with placebo. The p-value for each endpoint compared to placebo was