Amgen's Rocatinlimab Data Beats Placebo In Atopic Dermatitis Trial, But Analyst Says Data Raises Concerns Amid Competitive Market
Amgen's Rocatinlimab Data Beats Placebo In Atopic Dermatitis Trial, But Analyst Says Data Raises Concerns Amid Competitive Market
In an investor update on Tuesday, Amgen Inc (NASDAQ:AMGN) released data from Phase 3 trials of rocatinlimab and Uplizna (inebilizumab).
周二，安进公司（纳斯达克：AMGN）发布了rocatinlimab和Uplizna（inebilizumab）第3期临床试验的数据。
HORIZON Phase 3 trial evaluated rocatinlimab for atopic dermatitis (eczema) in 726 patients.
HORIZON第3期试验评估了rocatinlimab在726名患者中的特应性皮炎（湿疹）情况。
Amgen reported that rocatinlimab outperformed a placebo regarding the severity and extent of the disease.
安进报告称，rocatinlimab在疾病的严重程度和范围方面优于安慰剂。
- 32.8% of rocatinlimab-treated subjects achieved an EASI-75 response at week 24 vs. 13.7% placebo.
- 19.3% of rocatinlimab-treated subjects achieved a vIGA-AD 0/1 response at week 24 vs. 6.6% placebo.
- 16.4% of rocatinlimab-treated subjects achieved a rIGA 0/1 response at week 24 vs. 4.9% placebo.
- 32.8%接受rocatinlimab治疗的受试者在第24周时达到了EASI-75的反应，相比之下安慰剂只有13.7%。
- 19.3%接受rocatinlimab治疗的受试者在第24周时达到了vIGA-AD 0/1的反应，相比之下安慰剂只有6.6%。
- 16.4%接受rocatinlimab治疗的受试者在第24周时达到了rIGA 0/1的反应，相比之下安慰剂只有4.9%。
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MINT Phase 3 trial of Uplizna in generalized myasthenia gravis showed a clinically meaningful and statistically significant MG-ADL (Myasthenia Gravis Activities of Daily Living) score, a measure of the severity of myasthenia gravis symptoms.
MINt第3期试验显示Uplizna在全身性重症肌无力患者中展现了临床意义和统计学显著的MG-ADL（重症肌无力日常活动）评分，这是对重症肌无力症状严重程度的衡量。
After two doses of Uplizna, MG-ADL score showed an overall improvement of -4.2, versus -1.9 placebo adjusted.
接受两剂Uplizna后，MG-ADL评分显示总体改善达到-4.2，而安慰剂调整为-1.9。
The trial demonstrated a statistically significant improvement in the Quantitative Myasthenia Gravis (QMG) score, a clinical assessment that measures the severity of myasthenia gravis.
该试验表明，在定量重症肌无力（QMG）评分中存在显著统计学改善，这是一种测量重症肌无力严重程度的临床评估。
QMG score improvement with Uplizna compared to placebo at week 26 was -4.8 overall improvement compared to -2.5 placebo adjusted.
与安慰剂相比，Uplizna在第26周的QMG评分的改善为-4.8，而安慰剂调整为-2.5，总体改善。
No new safety signals were identified.
未发现新的安全信号。
STAT News noted that though the trials succeeded, the therapies did not beat existing competitors on the market.
STAt News指出，尽管试验取得成功，但这些疗法并未超越市场上现有的竞争对手。
51% of adults treated with Sanofi SA (NASDAQ:SNY)/ Regeneraon Pharmaceuticals Inc's (NASDAQ:REGN) Dupixent (dupilumab) achieved EASI-75 vs. 15% with placebo at Week 16 in SOLO 1 trial and 44% vs. 12% in SOLO 2 trial.
51%接受赛诺菲安万特（纳斯达克:SNY）/Regeneraon Pharmaceuticals Inc（纳斯达克:REGN）的Dupixent（dupilumab）的成年患者在SOLO 1试验的第16周达到EASI-75，而安慰剂为15%，在SOLO 2试验中为44%，而安慰剂为12%。
William Blair noted that rocatinlimab's data fell short of expectations, raising concerns about how its clinical profile stacks up in the increasingly competitive atopic dermatitis market, particularly as the broader ROCKET program unfolds.
William Blair指出，rocatinlimab的数据没有达到预期，引发了对其在日益竞争激烈的特应性皮炎市场中临床表现如何的担忧，尤其是在更为广泛的ROCKEt项目逐步展开之际。
On the other hand, the Uplizna results for myasthenia gravis exceeded William Blair's expectations, indicating a strong market potential for the treatment. Key advantages include its less frequent dosing and potential to reduce steroid use.
另一方面，Uplizna在重症肌无力方面的结果超出了William Blair的预期，表明该治疗在市场上有着强大的潜力。其主要优势包括用药频率较低，以及可能减少类固醇使用。
The focus will be determining Uplizna's position within the myasthenia gravis treatment landscape alongside other options like FcRn, IVIg, complement inhibitors, rituximab, and more. Additionally, the potential for Uplizna's CD19-targeting strategy in autoimmune diseases will be closely watched, especially with competitors like Cullinan Therapeutics, Inc. (NASDAQ:CGEM).
焦点将放在确定Uplizna在重症肌无力治疗领域的位置上，与FcRn、IVIg、补体抑制剂、利妥昔单抗等其他选择一起。另外，Uplizna在自身免疫疾病中CD19靶向策略的潜力将受到密切关注，特别是与Cullinan Therapeutics, Inc.（纳斯达克:CGEM）等竞争对手的比较。
Price Action: AMGN stock is trading lower by 2.09% to $324.04 at the last check on Wednesday.
股价走势：AMGN股票在周三最后检查时下跌2.09%，报324.04美元。
- Private Equity Firms Circle Sanofi's Consumer Health Business Amid Potential Spinoff.
- 私募股权公司围绕赛诺菲安万特的消费业务展开活动，可能进行潜在的剥离。
Photo via Shutterstock
图片来自shutterstock。