Effectiveness and Safety of Bempedoic Acid in Combination With Ezetimibe and Either Rosuvastatin or Atorvastatin in Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia: an Observational Study

Data on the real-world use and effectiveness and safety of bempedoic acid combined with both a statin and ezetimibe in clinical practice is limited. There is an increased focus on using combination therapy to lower LDL-C.

Start Date03 Mar 2025

Sponsor / Collaborator

Daiichi Sankyo Europe GmbH

NCT06742853 / Not yet recruitingPhase 1

A Phase 1, Randomized, Single-blind, Placebo-controlled Study to Investigate the Pharmacokinetics, Safety, Tolerability, and Efficacy of AZD0780 in Combination With Ezetimibe, Ezetimibe/Rosuvastatin, or Ezetimibe/Bempedoic Acid in Healthy Male and Female Participants 18 to 75 Years of Age With Elevated LDL-C.

The main aim of this study is to assess the effects of AZD0780 when added on top of ezetimibe or ezetimibe and rosuvastatin or ezetimibe and bempedoic acid.

Start Date20 Dec 2024

Sponsor / Collaborator

AstraZeneca PLC

CTRI/2024/11/076537 / Not yet recruitingPhase 4

Effectiveness Of Bempedoic Acid -Ezetimibe Fixed Dose Combination On Insulin Sensitivity In Diabetic Dyslipidemic Patients - A Prospective, Open-label, Randomized Controlled Trial. - NIL

Start Date14 Nov 2024

Sponsor / Collaborator-

100 Clinical Results associated with Ezetimibe

100 Translational Medicine associated with Ezetimibe

100 Patents (Medical) associated with Ezetimibe

3,658

Literatures (Medical) associated with Ezetimibe

01 Mar 2025·SPECTROCHIMICA ACTA PART A-MOLECULAR AND BIOMOLECULAR SPECTROSCOPY

Eco-friendly synchronous spectrofluorimetry coupled with chemometrics for simultaneous determination of ezetimibe and propranolol in pharmaceutical formulations and spiked plasma samples

Article

Author: Alqahtani, Taha ; Alshehri, Adil ; Fatease, Adel Al ; Almrasy, Ahmed A. ; Alqahtani, Ali ; Almrasy, Ahmed A

In this study, synchronous fluorescence spectroscopic methods coupled with chemometric techniques were developed and evaluated for the simultaneous quantification of ezetimibe and propranolol, two commonly prescribed cardiovascular drugs. Both drugs exhibit overlapping native fluorescence, posing a challenge for their selective determination. To address this, chemometric models including partial least squares (PLS) and genetic algorithm-based variable selection (GA) were constructed using a calibration dataset based on a 5² factorial design resulting in 25 synthetic mixtures. The developed method has been optimized to account for factors such as solvent composition, micellar systems, and excitation/emission wavelengths that affect the fluorescence signals. The PLS and GA-PLS models were validated using an independent test set of 13 samples based on central composite design revealing the GA-PLS model provided improved quantitative performance with relative root mean square error of prediction (RRMSEP) values of 1.3939 and 1.0005 % for ezetimibe and propranolol, respectively, compared to 2.2502 and 2.3526 % for the PLS models. Hence, the GA-PLS models were successfully applied for the determination of ezetimibe and propranolol in pharmaceutical formulations and spiked plasma samples. Furthermore, the greenness and blueness of the proposed methods were compared against reported HPLC procedures using the AGREE and BAGI tools, revealing a greener analytical footprint for the developed method and higher analytical practicability posing as an environmental-friendly alternative to the standard HPLC technique.

01 Feb 2025·Clinical Nutrition ESPEN

Selective peroxisome proliferator-activated receptor-α modulator improves hypertriglyceridemia and muscle quality in patients with chronic kidney disease: A retrospective observational study

Article

Author: Isomoto, Hajime ; Fujino, Yudai ; Sugihara, Takaaki ; Kageyama, Kana ; Hanada, Hinako ; Takata, Tomoaki ; Taniguchi, Sosuke ; Iyama, Takuji ; Mae, Yukari

BACKGROUND & AIMS:

Patients with chronic kidney disease (CKD) often have additional health problems, including sarcopenia and sarcopenic obesity. These conditions involve ectopic fat accumulation within muscles. This ectopic fat deposition reduces muscle quality, leading to weaker muscle strength and poorer physical performance. Persistent hypertriglyceridemia contributes to ectopic fat accumulation. Metabolic abnormalities, including dyslipidemia, are major factors in CKD development. Triglycerides (TG) and muscle quality are thus important factors in CKD management. Recently developed selective peroxisome proliferator-activated receptor α modulator (SPPARMα) hold promises for improving hypertriglyceridemia. However, their effectiveness and impact on muscle quality in CKD patients remain unclear. This study aimed to evaluate the effect of SPPARMα on muscle quality and its efficacy in CKD patients.

METHODS:

This retrospective observational study involved CKD patients with dyslipidemia. We included patients who initiated medications for hypertriglyceridemia. We compared changes in lipid profiles, renal function, and muscle quality, assessed by phase angle, over six months between two groups: those receiving this type of medication and those receiving conventional treatment.

RESULTS:

Among 245 patients diagnosed with CKD and hypertriglyceridemia, 52 started medications for hypertriglyceridemia. Of these, 26 received SPPARMα, and 26 received conventional lipid-lowering medications (statins, ezetimibe, eicosapentaenoic acid, and fibrates). SPPARMα significantly reduced TG (from 296.8 ± 106.1 to 153.0 ± 86.1, p < 0.001) without affecting glomerular filtration rate or urinary protein levels. Conventional treatment also improved TG (from 261.6 ± 89.5 to 173.6 ± 81.3, p < 0.001). Only patients treated with SPPARMα showed significant improvement in muscle quality. Their phase angle increased from 5.41 ± 0.6 to 5.55 ± 0.6 after six months of treatment (p < 0.05).

CONCLUSIONS:

Our study demonstrates that the newly developed SPPARMα significantly lowers TG levels in CKD patients without harming their kidneys. Additionally, only patients treated with SPPARMα showed improvement in muscle quality. These findings suggest that SPPARMα may be a valuable treatment option for CKD patients with dyslipidemia, particularly those with low muscle quality.

01 Jan 2025·SPECTROCHIMICA ACTA PART A-MOLECULAR AND BIOMOLECULAR SPECTROSCOPY

Eco-friendly second derivative synchronous fluorescence spectroscopic method for simultaneous determination of rosuvastatin and ezetimibe in pharmaceutical capsules

Article

Author: Ramzy, Sherif ; Althobaiti, Yusuf S. ; Althobaiti, Yusuf S ; Almalki, Atiah H ; Almalki, Atiah H.

The fixed dose combination of Rosuvastatin and ezetimibe has recently received approval from the FDA for the treatment of elevated levels of low-density lipoprotein cholesterol in adults. Herein, an eco-friendly and highly sensitive spectrofluorimetric method was developed and validated for simultaneous determination of rosuvastatin and ezetimibe in commercial capsules. The developed method involved synchronous fluorescence spectroscopy combined with second derivative spectroscopy to resolve the overlapping fluorescence spectra of rosuvastatin and ezetimibe. The studied drugs were measured in synchronous mode at Δλ of 40 and their recorded synchronous fluorescence spectra were derivatized into second-order spectra, enabling the selective quantification of rosuvastatin and ezetimibe at 370 nm and 312 nm, respectively. Optimization studies regarding to the influence of buffer pH, incorporation of surfactant, choice of diluting solvent, and synchronous Δλ were carried out. The method was validated using the validation characteristics listed in ICH Q2(R1). The calibration curves displayed satisfactory linear relationships across the calibration range of 0.1-2 µg/mL for rosuvastatin and 0.05-3 µg/mL for ezetimibe. The methodology demonstrated robustness to minor modifications in the procedural parameters and selectivity in quantifying the studied drugs in synthetic mixed solutions and commercial capsules without interference. Furthermore, the level of environmental friendliness and sustainability of the suggested spectrofluorimetric approach was assessed in relation to two previously documented methodologies utilizing the AGREE metric. The findings indicated that the suggested method demonstrated a notably superior level of sustainability in comparison to the documented methods.

134

News (Medical) associated with Ezetimibe

16 Dec 2024

·www.prnewswire.com

Menarini Group announces Positive Topline Data from Pivotal Phase 3 BROADWAY & TANDEM Clinical Trials Evaluating Obicetrapib and the Fixed-Dose Combination Obicetrapib with Ezetimibe 10 mg

– Both pivotal studies achieved primary endpoints of LS mean reduction in LDL-C on top of maximally tolerated lipid-modifying therapies with high statistical significance (p<0.0001) – Approximately 50% of patients in BROADWAY (Obicetrapib monotherapy) and over 70% of patients in TANDEM (Fixed Dose Combination Obicetrapib with Ezetimibe) achieved LDL-C target below 55 mg/dL – In BROADWAY a 21% reduction in major adverse cardiovascular events favoring Obicetrapib was observed at one year -- In both studies, Obicetrapib monotherapy and the fixed dose combination with Ezetimibe were shown to be well tolerated FLORENCE, Italy, Dec. 16, 2024 /PRNewswire/ -- Menarini Group today announces positive topline data from the Phase 3 BROADWAY (NCT05142722) and the Phase 3 TANDEM (NCT06005597) clinical trials sponsored by 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. The Phase 3 BROADWAY clinical trial (NCT05142722) was designed to evaluate 10 mg Obicetrapib in adult patients with heterozygous familial hypercholesterolemia ("HeFH") and/or established atherosclerotic cardiovascular disease ("ASCVD"), whose LDL-C is not adequately controlled, despite being on maximally tolerated lipid-lowering therapy. The phase 3 TANDEM clinical trial (NCT06005597) was designed to evaluate 10 mg Obicetrapib and 10 mg Ezetimibe fixed-dose combination in adult patients with HeFH and/or ASCVD or multiple ASCVD risk factors, whose LDL-C is not adequately controlled, despite being on maximally tolerated lipid-lowering therapy. The primary endpoint in BROADWAY was the least-squares mean of the percent change in LDL-C from baseline to day 84 for Obicetrapib 10 mg compared to placebo. The primary endpoint was achieved with statistical significance with an LDL-C reduction of 33% (p<0.0001). The observed changes in other biomarkers, including increase of high-density lipoprotein cholesterol ("HDL-C") and reduction of non-HDL-C, lipoprotein(a) ("Lp(a)"), apolipoprotein B ("ApoB"), and Apolipoprotein A1 (ApoA1) were positive and consistent with data reported from prior clinical trials. As part of the safety analysis, key adverse events ("AE") of special interests were monitored. Among these AEs, glycemic control and renal function favoured Obicetrapib. In addition, the BROADWAY trial adjudicated MACE, including death, non-fatal myocardial infarction, non-fatal stroke and coronary revascularization showing a 21% reduction in the first 4-point MACE favoring Obicetrapib. Overall, Obicetrapib was also observed to be well tolerated, with safety data, including blood pressure, comparable to placebo. The treatment discontinuation rate for the Obicetrapib arm was 11.1% versus 12.4% for placebo. The incidence of treatment-emergent adverse events ("TEAEs"), study-drug related TEAEs, and treatment-emergent serious adverse events ("TESAEs") are summarized in the table below. The co-primary endpoints in TANDEM were percent change from baseline in LDL-C of the fixed-dose combination compared to each monotherapy arm after 84 days and Obicetrapib 10 mg compared to placebo after day 84. Secondary endpoints incorporated percent changes from baseline in other biomarkers, including Lp(a), non-HDL-c and APO B. The TANDEM trial met all co-primary endpoints, including the fixed dose combination Obicetrapib with Ezetimibe achieving an LS mean reduction of 48.6% (p < 0.0001) compared to placebo at day 84. LDL-C percentage change at Day 84 In the trial, the fixed-dose combination of Obicetrapib and Ezetimibe was observed to be well tolerated, with safety data comparable to placebo. The below table summarizes study drug-related treatment emergent adverse events ("TEAEs") and study drug-related treatment emergent serious adverse events ("TESAEs"). "Cardiovascular diseases (CVDs) are the leading cause of death globally, taking an estimated 17.9 million lives each year. Despite the widespread availability of lipid lowering therapies, CVD-related deaths have risen and patients remain above LDL-C targets, many patients failing to achieve guidelines recommended LDL.C target goals. Patients and their doctors need additional options. We are very pleased that BROADWAY and TANDEM data and previously announced BROOKLYN data confirmed the ability of Obicetrapib as a monotherapy or in a fixed dose combination with ezetimibe to significantly reduce LDL-C and help patients achieve recommended target goals. This represents a key milestone in our commitment to offer patients suffering from cardiovascular diseases in Europe, a potential first in class, low dose, once daily oral treatment in the fight against cardiovascular diseases, a mission of over 30 years for our company" said Elcin Barker Ergun, Chief Executive Officer of the Menarini Group. Design of the Pivotal Phase 3 BROADWAY Clinical Trial The 52-week, global, pivotal, Phase 3, randomized, double-blind, placebo-controlled multicenter study evaluated the efficacy and safety of 10 mg Obicetrapib compared to placebo as an adjunct to maximally tolerated lipid-lowering therapies in patients with ASCVD and/or HeFH whose LDL-C is not adequately controlled. The study was conducted at sites in North America, Europe, Asia and Australia. A total of 2,530 patients were randomized 2:1 to receive 10 mg Obicetrapib or placebo dosed as a once-daily oral treatment, with or without food for 52 weeks. The mean baseline LDL-C for enrolled patients in the Obicetrapib arm was approximately 100 mg/dL despite high intensity statin use reported by nearly 70% of patients during screening. Females comprised approximately 34% of the study population and the median age of participants at baseline was 65 years. The primary endpoint was percent change from baseline in LDL-C of Obicetrapib 10 mg compared to placebo after 84 days which showed a reduction of 33% with imputation. Secondary endpoints also included percent changes from baseline of Obicetrapib 10 mg compared to placebo in ApoB, Lp(a), ApoA1, HDL-C, non-HDL-C, total cholesterol, and triglycerides at day 84, and on LDL-C levels at days 180 and 365 (-34% and -24%, respectively with p<0.0001). Other outcome measures include time from randomization until the first confirmed occurrence of MACE in the Obicetrapib arm compared to placebo. The trial also evaluated the safety and tolerability profile of Obicetrapib. Design of the Pivotal Phase 3 TANDEM Clinical Trial The pivotal, Phase 3, randomized, double-blind, four-arm, placebo-controlled multicenter study evaluated the effect of 10 mg Obicetrapib and 10 mg ezetimibe as a fixed-dose combination on LDL-C levels, compared to both ezetimibe 10 mg and Obicetrapib 10 mg monotherapy and to placebo. The study was conducted at sites across the United States, and a total of 407 patients with HeFH and/or ASCVD or ASCVD risk equivalents, who had a baseline LDL-C of at least 70 mg/dL, were randomized 1:1:1:1 to receive 10 mg Obicetrapib and 10 mg ezetimibe fixed-dose combination, 10 mg Obicetrapib, 10 mg ezetimibe or placebo for an 84-day treatment period. The mean baseline LDL-C for enrolled patients in the obicetrapib-ezetimibe arm was 97 mg/dL despite high intensity statin use reported by approximately 74% of patients during screening. In addition to measuring the co-primary endpoints and secondary endpoints, the trial also evaluated the safety and tolerability profile of Obicetrapib. Obicetrapib's Global Pivotal Phase 3 Program Obicetrapib global, pivotal Phase 3 clinical development program consists of four studies in over 12,250 patients, three for obicetrapib monotherapy and one for the fixed-dose combination ("FDC") with ezetimibe: BROOKLYN evaluated Obicetrapib in patients with HeFH, whose LDL-C is not adequately controlled, despite being on maximally tolerated lipid-lowering therapy (NCT05425745). Study enrollment of over 350 patients was completed in April 2023. Topline data reported in the third quarter of 2024. BROADWAY evaluated Obicetrapib in adult patients with established ASCVD and/or HeFH, whose LDL-C is not adequately controlled, despite being on maximally tolerated lipid-lowering therapy (NCT05142722). Study enrollment of over 2,500 patients was completed in July 2023. Topline data reported in the fourth quarter of 2024. TANDEM evaluated Obicetrapib as part of a FDC tablet with ezetimibe, a non-statin oral LDL-lowering therapy, in patients with established ASCVD or multiple risk factors for ASCVD and/or HeFH, whose LDL-C is not adequately controlled despite being on maximally tolerated lipid-lowering therapy (NCT06005597). Study enrollment of over 400 patients was completed in July 2024. Topline data reported in November 2024 PREVAIL is a cardiovascular outcomes trial ("CVOT") evaluating Obicetrapib in patients with a history of ASCVD, whose LDL-C is not adequately controlled, despite being on maximally tolerated lipid-lowering therapy (NCT05202509). Study enrollment of over 9,500 patients was completed in April 2024. About Obicetrapib Obicetrapib is a novel, oral, low-dose CETP inhibitor under development to overcome the limitations of current LDL-lowering treatments. In each of the Phase 2 trials, ROSE2, TULIP, ROSE, as well as the Phase 3 BROOKLYN, BROADWAY and TANDEM trials, evaluating Obicetrapib as monotherapy or combination therapy, it was observed statistically significant LDL-lowering combined with a side effect profile similar to that of placebo. The Phase 3 study cardiovascular outcomes trial PREVAIL commenced in March 2022 and is designed to assess the potential of Obicetrapib to reduce occurrences of major adverse cardiovascular events, including cardiovascular death, non-fatal myocardial infarction, non-fatal stroke and non-elective coronary revascularization. The enrollment of PREVAIL was completed in April 2024 and randomized over 9,500 patients. About The Menarini Group The Menarini Group is a leading international pharmaceutical and diagnostics company, with a turnover of $4.7 billion and over 17,000 employees. Menarini is focused on therapeutic areas of high unmet needs with products for cardiology, oncology, pneumology, gastroenterology, infectious diseases, diabetology, inflammation, and analgesia. With 18 production sites and 9 Research and Development centers, Menarini's products are available in 140 countries worldwide. For further information, please visit . About NewAmsterdam NewAmsterdam Pharma (Nasdaq: NAMS) is a late-stage biopharmaceutical company whose mission is to improve patient care in populations with metabolic diseases where currently approved therapies have not been adequate or well tolerated. We seek to fill a significant unmet need for a safe, well-tolerated and convenient LDL-lowering therapy. In multiple phase 3 studies, NewAmsterdam is investigating Obicetrapib, an oral, low-dose and once-daily CETP inhibitor, alone or as a fixed-dose combination with ezetimibe, as LDL-C lowering therapies to be used as an adjunct to statin therapy for patients at risk of CVD with elevated LDL-C, for whom existing therapies are not sufficiently effective or well tolerated. Logo - SOURCE Menarini Industrie Farmaceutiche Riunite WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 3Clinical ResultAHA

13 Dec 2024

·www.globenewswire.com

NewAmsterdam Pharma Announces Closing of Upsized $479.0 Million Public Offering of Ordinary Shares and Pre-Funded Warrants, Including Full Exercise of the Underwriters’ Option to Purchase Additional Shares

NAARDEN, The Netherlands and MIAMI, Dec. 13, 2024 (GLOBE NEWSWIRE) -- NewAmsterdam Pharma Company N.V. (Nasdaq: NAMS; “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 the closing of the previously announced underwritten public offering of (i) 14,667,347 of the Company’s ordinary shares, nominal value €0.12 per share (the “Ordinary Shares”), at a public offering price of $24.50 per share, which includes the exercise in full of the underwriters’ option to purchase an additional 2,550,000 Ordinary Shares, and (ii) to certain investors that so choose in lieu of Ordinary Shares, pre-funded warrants to purchase 4,882,653 Ordinary Shares at a public offering price of $24.4999 per pre-funded warrant, which represents the per share public offering price for the Ordinary Shares less the $0.0001 per share exercise price for each such pre-funded warrant (such offering, the “Offering”). All of the securities sold in the Offering were sold by the Company. The net proceeds to the Company from the Offering, including the proceeds from the exercise by the underwriters of their option to purchase the additional shares, were approximately $452.6 million after deducting underwriting discounts and commissions and estimated offering expenses payable by the Company. Jefferies, Goldman Sachs & Co., Leerink Partners, TD Cowen, Guggenheim Securities and William Blair acted as joint book-running managers for the Offering. The Offering was made pursuant to a registration statement on Form S-3, including a base prospectus, that was initially declared effective by the U.S. Securities and Exchange Commission (the “SEC”) on July 12, 2024 and a related registration statement that was filed with the SEC on December 11, 2024 pursuant to Rule 462(b) under the Securities Act of 1933 (and which became automatically effective upon filing). A preliminary prospectus supplement and accompanying prospectus relating to and describing the terms of the Offering were filed with the SEC and are available free of charge by visiting EDGAR on the SEC’s website at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus may also be obtained free of charge from: Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, NY 10022, or by telephone at (877) 821-7388, or by email at Prospectus_Department@Jefferies.com; Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, or by telephone at (866) 471-2526, or by email at Prospectus-ny@ny.email.gs.com; Leerink Partners LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, or by telephone at (800) 808-7525, ext. 6105, or by email at syndicate@leerink.com; TD Securities (USA) LLC, 1 Vanderbilt Avenue, New York, NY 10017, or by telephone at (855) 495-9846, or by email at TD.ECM_Prospectus@tdsecurities.com; Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Avenue, New York, NY 10017, or by telephone at (212) 518-9544, or by email at GSEquityProspectusDelivery@guggenheimpartners.com; or William Blair & Company, L.L.C., Attention: Prospectus Department, 150 North Riverside Plaza, Chicago, IL 60606, or by telephone at (800) 621-0687, or by email at prospectus@williamblair.com. This press release shall not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. Van Lanschot Kempen N.V. acted as a financial adviser to the Company. About NewAmsterdam NewAmsterdam Pharma (Nasdaq: NAMS) is a late-stage biopharmaceutical company whose mission is to improve patient care in populations with metabolic diseases where currently approved therapies have not been adequate or well-tolerated. We seek to fill a significant unmet need for a safe, well-tolerated and convenient LDL-lowering therapy. In multiple phase 3 studies, NewAmsterdam is investigating obicetrapib, an oral, low-dose and once-daily CETP inhibitor, alone or as a fixed-dose combination with ezetimibe, as LDL-C lowering therapies to be used as an adjunct to statin therapy for patients at risk of CVD with elevated LDL-C, for whom existing therapies are not sufficiently effective or well-tolerated. Company ContactMatthew PhilippeP: 1-917-882-7512 matthew.philippe@newamsterdampharma.com Media ContactSpectrum Science on behalf of NewAmsterdamJaryd LeadyP:1-856-803-7855jleady@spectrumscience.com Investor ContactPrecision AQ on behalf of NewAmsterdamAustin MurtaghP: 1-212-698-8696 austin.murtagh@precisionaq.com

Phase 3

12 Dec 2024

·www.globenewswire.com

NewAmsterdam Pharma Announces Pricing of Upsized $416.5 Million Public Offering of Ordinary Shares and Pre-Funded Warrants

NAARDEN, the Netherlands and MIAMI, Dec. 11, 2024 (GLOBE NEWSWIRE) -- NewAmsterdam Pharma Company N.V. (Nasdaq: NAMS; “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 the pricing of the previously announced underwritten public offering of (i) 12,117,347 of the Company’s ordinary shares, nominal value €0.12 per share (the “Ordinary Shares”), at a public offering price of $24.50 per share and (ii) to certain investors that so choose in lieu of Ordinary Shares, pre-funded warrants to purchase 4,882,653 Ordinary Shares at a public offering price of $24.4999 per pre-funded warrant, which represents the per share public offering price for the Ordinary Shares less the $0.0001 per share exercise price for each such pre-funded warrant (“Pre-Funded Warrants,” such offering, the “Offering”). The proceeds to the Company from the Offering, before deducting underwriting discounts and commissions and offering expenses payable by the Company, are expected to be approximately $416.5 million. In addition, the Company has granted the underwriters a 30-day option to purchase up to an additional 2,550,000 Ordinary Shares at the public offering price, less underwriting discounts and commissions. The Offering is expected to close on or about December 13, 2024, subject to satisfaction of customary closing conditions. Jefferies, Goldman Sachs & Co., Leerink Partners, TD Cowen, Guggenheim Securities and William Blair are acting as joint book-running managers for the Offering. The Offering is being made pursuant to a registration statement on Form S-3, including a base prospectus, that was initially declared effective by the U.S. Securities and Exchange Commission (the “SEC”) on July 12, 2024 and a related registration statement that was filed with the SEC on December 11, 2024 pursuant to Rule 462(b) under the Securities Act of 1933 (and which became automatically effective upon filing). A preliminary prospectus supplement and accompanying prospectus relating to and describing the terms of the Offering were filed with the SEC and are available free of charge by visiting EDGAR on the SEC’s website at www.sec.gov. Copies of the final prospectus supplement, when available, and the accompanying prospectus may also be obtained free of charge from: Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, NY 10022, or by telephone at (877) 821-7388, or by email at Prospectus_Department@Jefferies.com; Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, or by telephone at (866) 471-2526, or by email at Prospectus-ny@ny.email.gs.com; Leerink Partners LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, or by telephone at (800) 808-7525, ext. 6105, or by email at syndicate@leerink.com; TD Securities (USA) LLC, 1 Vanderbilt Avenue, New York, NY 10017, or by telephone at (855) 495-9846, or by email at TD.ECM_Prospectus@tdsecurities.com; Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Avenue, New York, NY 10017, or by telephone at (212) 518-9544, or by email at GSEquityProspectusDelivery@guggenheimpartners.com; or William Blair & Company, L.L.C., Attention: Prospectus Department, 150 North Riverside Plaza, Chicago, IL 60606, or by telephone at (800) 621-0687, or by email at prospectus@williamblair.com. This press release shall not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. About NewAmsterdam NewAmsterdam Pharma (Nasdaq: NAMS) is a late-stage biopharmaceutical company whose mission is to improve patient care in populations with metabolic diseases where currently approved therapies have not been adequate or well-tolerated. We seek to fill a significant unmet need for a safe, well-tolerated and convenient LDL-lowering therapy. In multiple phase 3 studies, NewAmsterdam is investigating obicetrapib, an oral, low-dose and once-daily CETP inhibitor, alone or as a fixed-dose combination with ezetimibe, as LDL-C lowering therapies to be used as an adjunct to statin therapy for patients at risk of CVD with elevated LDL-C, for whom existing therapies are not sufficiently effective or well-tolerated. Forward-Looking Statements Certain statements included in this document that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements generally are accompanied by words such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “should,” “would,” “plan,” “predict,” “potential,” “seem,” “seek,” “future,” “outlook” and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements regarding the consummation of the proposed Offering. These statements are based on various assumptions, whether or not identified in this document, and on the current expectations of the Company’s management and are not predictions of actual performance. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as and must not be relied on as a guarantee, an assurance, a prediction, or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and may differ from assumptions. Many actual events and circumstances are beyond the control of the Company. These forward-looking statements are subject to a number of risks and uncertainties, including changes in domestic and foreign business, market, financial, political, and legal conditions; risks related to the approval of the Company’s product candidate and the timing of expected regulatory and business milestones, including potential commercialization; ability to negotiate definitive contractual arrangements with potential customers; the impact of competitive product candidates; ability to obtain sufficient supply of materials; global economic and political conditions, including the Russia-Ukraine and Israel-Hamas conflicts; the effects of competition on the Company’s future business; and those factors described in the Company’s public filings with the SEC. Additional risks related to the Company’s business include, but are not limited to: uncertainty regarding outcomes of the Company’s ongoing clinical trials, particularly as they relate to regulatory review and potential approval for its product candidate; risks associated with the Company’s efforts to commercialize a product candidate; the Company’s ability to negotiate and enter into definitive agreements on favorable terms, if at all; the impact of competing product candidates on the Company’s business; intellectual property related claims; the Company’s ability to attract and retain qualified personnel; and the Company’s ability to continue to source the raw materials for its product candidate. If any of these risks materialize or the Company’s assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. There may be additional risks that the Company does not presently know or that the Company currently believes are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. In addition, forward-looking statements reflect the Company’s expectations, plans, or forecasts of future events and views as of the date of this document and are qualified in their entirety by reference to the cautionary statements herein. The Company anticipates that subsequent events and developments may cause the Company’s assessments to change. These forward-looking statements should not be relied upon as representing the Company’s assessment as of any date subsequent to the date of this communication. Accordingly, undue reliance should not be placed upon the forward-looking statements. Neither the Company nor any of its affiliates undertakes any obligation to update these forward-looking statements, except as may be required by law. Company ContactMatthew PhilippeP: 1-917-882-7512 matthew.philippe@newamsterdampharma.com Media ContactSpectrum Science on behalf of NewAmsterdamJaryd Leady P:1-856-803-7855jleady@spectrumscience.com Investor ContactPrecision AQ on behalf of NewAmsterdamAustin MurtaghP: 1-212-698-8696 austin.murtagh@precisionaq.com

Phase 3

100 Deals associated with Ezetimibe

External Link

KEGG	Wiki	ATC	Drug Bank
D01966	Ezetimibe	C10AX09	DB00973

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Hyperlipidemias	US	Organon & Co.	05 Jun 2008
Hypercholesterolemia	US	Organon & Co.	23 May 2006
Cardiovascular Diseases	AU	Organon Pharma Pty Ltd.	23 Jun 2003
Heterozygous familial hypercholesterolemia	AU	Organon Pharma Pty Ltd.	23 Jun 2003
Homozygous familial hypercholesterolemia	US	Organon & Co.	25 Oct 2002
Primary hypercholesterolemia	US	Organon & Co.	25 Oct 2002
Sitosterolemia	US	Organon & Co.	25 Oct 2002

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Coronary Disease	Phase 3	-	Schering-Plough Corp.	12 Jul 2005
Atherosclerosis	Phase 3	-	Organon & Co.	01 May 2003
Coronary Artery Disease	Phase 3	-	Merck Sharp & Dohme Corp.	01 May 2003
Coronary Artery Disease	Phase 3	-	Organon & Co.	01 May 2003
Hyperlipidemia, Familial Combined	Phase 3	-	Organon & Co.	01 Dec 2002
Hypertriglyceridemia	Phase 3	-	Organon & Co.	01 Dec 2002
Hyperlipoproteinemia Type II	Phase 3	-	Organon & Co.	01 Jul 2002
Diabetes Mellitus, Type 2	Phase 3	-	Organon & Co.	01 Dec 2001

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04369664 (CHORD, CTgov)	Phase 4	Diabetes Mellitus, Type 2	151	PCSK9 inhibitor+Ezetimibe 10mg+Statin (Type 2 Diabetes Group)	gdmvvigwyh(qkntcqxpat) = pnkgitdjoc hjqlgyfcuz (qpjdxqvpor, wjknrkqfdq - lupyhyritf) View more	-	17 Oct 2024
				PCSK9 inhibitor+Ezetimibe 10mg+Statin (Control Group)	gdmvvigwyh(qkntcqxpat) = djmjtyoiol hjqlgyfcuz (qpjdxqvpor, uwnnmvgmkc - brygktczpn) View more
ESC2024	Not Applicable	Myocardial Infarction	-	Ezetimibe use	rzyqbjrocn(ngercifvkh) = sylqcqbrts ujjksdrshs (itpwzdsbki )	Positive	31 Aug 2024
				No Ezetimibe use	rzyqbjrocn(ngercifvkh) = mfqulgxrwp ujjksdrshs (itpwzdsbki )
ATS2024	Not Applicable	Idiopathic Pulmonary Fibrosis	-	Ezetimibe users	cfbtxgsrtm(cdjeojvpmk) = cuzbzyarvz toctokmdgo (eqvhyuhool )	Positive	19 May 2024
				Non-users	cfbtxgsrtm(cdjeojvpmk) = eqgqubliwg toctokmdgo (eqvhyuhool )
NCT04638400 (CTgov)	Phase 4	Inflammation \| Atherosclerosis \| Obesity ... View more	10	Simvastatin 40mg (Simvastatin)	memmyylefh(tfnqcvmyzz) = adnsnwpwta cajiwpngkw (mangoppeib, mlkjrlirpk - jttqdtdmeg) View more	-	23 Jan 2024
				Ezetimibe 10mg (Ezetimibe)	memmyylefh(tfnqcvmyzz) = rbgqbpuzpc cajiwpngkw (mangoppeib, wcdkcwhczf - nlzygnoqvh) View more
NCT00988364 (Merck-123, CTgov)	Phase 4	Metabolic Syndrome	30	ezetimibe (Ezetimibe)	xcvfdrbkey(iveaykatdg) = fvzccedwdl yuvenhngkv (omopmcxibe, bfrgorflyx - ybvmndrtho) View more	-	30 Nov 2023
				Simvastatin (Simvastatin)	xcvfdrbkey(iveaykatdg) = svjgrvvkoj yuvenhngkv (omopmcxibe, rntybpxaug - hncjvsmcca) View more
AASLD2023	Not Applicable	-	88	Glecaprevir/pibrentasvir + Ezetimibe	adoclqphvh(tsalskktyi) = 27 (46%) patients developed HCV antibodies that persisted post-treatment smgfhrejwk (eccmuxkdza )	-	10 Nov 2023
FRI094 (ENDO2023)	Not Applicable	Sitosterolemia	1	Ezetimibe 20 mg daily	zvcscqmfgc(emsvglwjfh) = duspliitxt tilfqcaepx (jvveoclbme ) View more	Positive	05 Oct 2023
				Atorvastatin 20 mg daily	zvcscqmfgc(emsvglwjfh) = nwcgtwstql tilfqcaepx (jvveoclbme ) View more
IMPROVE-IT (ESC2023)	Not Applicable	-	-	Ezetimibe	hclsetjnfk(mdaexqwmqn): RR = 0.77 (95% CI, 0.62 - 0.96), P-Value = 0.018	Positive	26 Aug 2023
				Placebo
ADA2023	Not Applicable	Diabetes Mellitus, Type 2	-	Moderate-intensity statin with ezetimibe combination therapy	ibgqpkrafu(cioczdgzim): HR = 0.7 (95% CI, 0.52 - 0.93), P-Value = 0.014 View more	Positive	20 Jun 2023
				High-intensity statin monotherapy
Pubmed \| J Stroke Manual	Not Applicable	Ischemic stroke	530	Rosuvastatin 10mg/Ezetimibe 10mg	snnrdqdrfm(wqazujwmpu) = vsgzlrzznj elwslhvdun (ysbjqoqupd ) View more	Positive	01 May 2023
				Rosuvastatin 20mg	snnrdqdrfm(wqazujwmpu) = lvygexngdj elwslhvdun (ysbjqoqupd ) View more

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