Business
NewAmsterdam Pharma Provides Corporate Update and Reports First Quarter Financial Highlights
-- Completed enrollment in BROOKLYN Phase 3 clinical trial evaluating obicetrapib in patients with heterozygous familial hypercholesterolemia (“HeFH”) ahead
About this update from Newamsterdam Pharma Company N.v.
[{"type":"text","content":"-- Completed enrollment in BROOKLYN Phase 3 clinical trial evaluating obicetrapib in patients with heterozygous familial hypercholesterolemia (“HeFH”) ahead of schedule; topline results expected in 2H 2024 -- -- Announced positive topline results in January 2023 and scheduled to present full data from ROSE2 Phase 2 clinical trial evaluating combination of obicetrapib and ezetimibe at the National Lipid Association (“NLA”) Scientific Sessions in June 2023 -- -- Expect to report topline results from Phase 2 dose-finding trial of obicetrapib in Japanese patients with dyslipidemia and from Phase 2a trial evaluating obicetrapib in patients with early Alzheimer’s disease in 2H 2023 -- -- Topline data from pivotal Phase 3 BROADWAY and PREVAIL trials on-track to be announced in 2H 2024 and 2026, respectively -- NAARDEN, the Netherlands and MIAMI, May 08, 2023 (GLOBE NEWSWIRE) -- NewAmsterdam Pharma Company N.V. (Nasdaq: NAMS or “NewAmsterdam” or the “Company”), a clinical-stage company focused on the research and development of transformative oral therapies for major cardiometabolic diseases, today provided a corporate update and announced financial highlights for the first quarter ended March 31, 2023. “We are pleased to report an exceptional start to the year, marked by key accomplishments across our business,” said Michael Davidson, M.D., Chief Executive Officer of NewAmsterdam. “We recently announced the early completion of enrollment in our Phase 3 BROOKLYN trial evaluating obicetrapib in patients with HeFH. Likewise, enrollment in our Phase 3 BROADWAY trial and Phase 3 cardiovascular outcomes (“CVOT”) PREVAIL trial continues to be strong. We have over 1,700 patients randomized in BROADWAY and over 3,400 patients randomized in PREVAIL and expect to complete enrollment in the middle of 2023 and the first quarter of 2024, respectively. We believe that the strong enrollment we have seen in each clinical trial, at a time when patients and investigators have the option of similar clinical trials using injectable drugs, reflects the significant unmet need for a potent oral therapy that can be used as an adjunct to maximally tolerated statin therapy to help patients achieve target low-density lipoprotein cholesterol (“LDL-C”) levels.” Dr. Davidson continued, “In addition, we plan to announce data from multiple Phase 2 trials in the coming...