NAARDEN, the Netherlands and MIAMI, May 23, 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 announced that it will present full data from ROSE2, a Phase 2 clinical trial evaluating obicetrapib in combination with ezetimibe as an adjunct to high-intensity statin therapy, in a late-breaking presentation at the National Lipid Association (“NLA”) Scientific Sessions, being held June 1-4 in Atlanta, Georgia. NewAmsterdam is developing a fixed dose combination of obicetrapib 10 mg and ezetimibe 10 mg, and expects to select a formulation to advance into a definitive bioequivalence trial and a Phase 3 safety and efficacy trial in the second half of 2023.
Details of the presentation are as follows:
Presentation Title: The combination of Obicetrapib and Ezetimibe lowers LDL-C in Patients on High Intensity Statins: Results from the ROSE2 Trial (NCT05266586)
Session Title: Late-Breaker Session
Session Date and Time: Saturday, June 3, 2023, 12:00 P.M. ET
Location: Omni Atlanta Hotel at CNN Center
Investor and Analyst Conference Call and Live Webcast
NewAmsterdam will host a conference call for investors and analysts to review the full data from ROSE2. The live webcast will begin at 8:00 a.m. ET on Monday, June 5 and will include remarks by Robert Rosenson, M.D., a Professor of Medicine, and Director of Cardiometabolic Disorders at the Icahn School of Medicine at Mount Sinai.
Participants may register for the conference call here. While not required, it is recommended that participants join the call ten minutes prior to the scheduled start.
A live webcast of the call will also be available under “Events & Presentations” in the Investors & News section of the Company’s website at https://ir.newamsterdampharma.com. The archived webcast will be available on NewAmsterdam’s website approximately two hours after the conference call and will be available for at least 30 days following the live event.
NewAmsterdam (Nasdaq: NAMS) is a clinical-stage biopharmaceutical company whose mission is to improve patient care in populations with cardiometabolic diseases where currently approved therapies have not been sufficiently successful or well tolerated. NewAmsterdam is investigating obicetrapib, an oral, low-dose and once-daily CETP inhibitor, as the preferred LDL-C lowering therapy to be used as an adjunct to maximally-tolerated statin therapy for high-risk cardiovascular disease (“CVD”) patients. Results from NewAmsterdam’s ROSE Phase 2b trial (presented at AHA Scientific Sessions in 2021) included observations that patients receiving obicetrapib 10 mg experienced a median reduction in LDL-C of 51% versus baseline in patients on high-intensity statin therapy (vs. a 7% reduction in the placebo arm). In addition, topline results from NewAmsterdam’s ROSE2 trial evaluating the combination of 10 mg obicetrapib and 10 mg ezetimibe demonstrated a median reduction in LDL-C levels of 59% versus baseline in patients on high-intensity statin therapy (vs. a 6% reduction in the placebo arm). Based in the Netherlands, NewAmsterdam recently completed a business combination with FLAC, a special purpose acquisition company sponsored by an affiliate of Frazier Healthcare Partners. Proceeds from this transaction were approximately $328 million, prior to deducting transaction expenses. In June 2022, NewAmsterdam entered into an exclusive licensing agreement with the Menarini Group for the commercialization of obicetrapib in Europe, while retaining all rights to commercialize obicetrapib, if approved, in the rest of the world, as well as rights to develop certain forms of obicetrapib for other diseases such as Alzheimer’s disease. For more information, please visit: www.newamsterdampharma.com.
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Spectrum Science on behalf of NewAmsterdam
Stern Investor Relations on behalf of NewAmsterdam
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