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Newly Listed NewAmsterdam Pharma Touts Encouraging Data From High Cholesterol Treatment

Newly Listed NewAmsterdam Pharma Touts Encouraging Data From High Cholesterol Treatment

新上市的新阿姆斯特丹制药公司吹捧高胆固醇治疗的令人鼓舞的数据
Benzinga Real-time News ·  2023/01/17 12:22
  • NewAmsterdam Pharma Company N.V. (NASDAQ:NAMS) announced topline results from ROSE2 Phase 2 trial evaluating obicetrapib in combination with ezetimibe as an adjunct to high-intensity statin therapy.
  • NewAmsterdam is now selecting a formulated fixed-dose combination tablet of obicetrapib plus ezetimibe, a non-statin oral LDL-lowering therapy, to be tested in a definitive bioequivalence and a Phase 3 safety & efficacy trial.
  • The primary efficacy endpoint for the percent change from Day 1 to Day 84 in LDL-C for the combination treatment group compared to the placebo group was met.
  • Patients treated with the combination of obicetrapib and ezetimibe achieved a median reduction in LDL-C of 59% compared to patients treated with a placebo, who achieved a median reduction in LDL-C of 6%.
  • Overall, the obicetrapib combo therapy was well-tolerated, with a safety profile comparable to a placebo.
  • In November 2022, NewAmsterdam Pharma debuted a public company via a SPAC deal with Frazier Lifesciences Acquisition Corporation.
  • After the transaction, the company held a cash balance of approximately $490 million, which it believes will be sufficient to fund operations through 2026.
  • Price Action: NAMS shares are trading lower by 2.25% at $9.99 on the last check Tuesday.
  • 新阿姆斯特丹制药公司 N.V. 纳斯达克股票代码：NAMS）公布了 ROSE2 2期试验的主要结果，该试验评估了obicetrapib与依折替米贝联合用作高强度他汀类药物的辅助疗法。
  • NewAmsterdam现在正在选择obicetrapib加依泽替米贝（一种非他汀类口服低密度脂蛋白降低疗法）的配方固定剂量复方片剂，在明确的生物等效性和3期安全性和有效性试验中进行测试。
  • 与安慰剂组相比，联合治疗组的低密度脂蛋白C从第1天到第84天变化百分比的主要疗效终点已达到。
  • 与接受安慰剂治疗的患者相比，接受obicetrapib和ezetimibe联合治疗的患者的LDL-C中位数降低了59％，后者的低密度脂蛋白C中位数降低了6％。
  • 总体而言，obicetrapib联合疗法耐受性良好，其安全性与安慰剂相当。
  • 2022 年 11 月，NewAmsterdam Pharma 通过与 SPAC 的交易首次亮相一家上市公司 弗雷泽生命科学收购公司。
  • 交易完成后，该公司持有约4.9亿美元的现金余额，该公司认为这将足以为2026年的运营提供资金。
  • 价格走势： 在周二的最后一张支票中，NAMS股价下跌了2.25％，至9.99美元。
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