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NewAmsterdam Pharma Announces Positive Topline Results from Phase 2b Dose-Finding Trial Evaluating Obicetrapib in Japanese Patients
-- Achieved Primary Endpoint with Statistically Significant 45.8% Median Reduction in LDL-C (p -- 29.7% Median Reduction in Apo B and 37.0% Median Reduction
About this update from Newamsterdam Pharma Company N.v.
[{"type":"text","content":"-- Achieved Primary Endpoint with Statistically Significant 45.8% Median Reduction in LDL-C (p -- 29.7% Median Reduction in Apo B and 37.0% Median Reduction in non-HDL-C from Baseline (p -- 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, June 05, 2023 (GLOBE NEWSWIRE) -- 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 ...