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).
週二，安進公司（納斯達克：AMGN）發佈了rocatinlimab和Uplizna（inebilizumab）第3期臨床試驗的數據。
HORIZON Phase 3 trial evaluated rocatinlimab for atopic dermatitis (eczema) in 726 patients.
HORIZON第3期試驗評估了rocatinlimab在726名患者中的特應性皮炎（溼疹）情況。
Amgen reported that rocatinlimab outperformed a placebo regarding the severity and extent of the disease.
安進報告稱，rocatinlimab在疾病的嚴重程度和範圍方面優於安慰劑。
- 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治療的受試者在第24周時達到了EASI-75的反應，相比之下安慰劑只有13.7%。
- 19.3%接受rocatinlimab治療的受試者在第24周時達到了vIGA-AD 0/1的反應，相比之下安慰劑只有6.6%。
- 16.4%接受rocatinlimab治療的受試者在第24周時達到了rIGA 0/1的反應，相比之下安慰劑只有4.9%。
Also Read: Amgen's Mixed Q2 Results Highlight Obesity Drug Potential, Analysts Focus Shifts To Upcoming Clinical Readouts.
另請閱讀：安進的混合第二季度業績突顯肥胖藥物潛力，分析師關注點轉向即將發佈的臨床結果。
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期試驗顯示Uplizna在全身性重症肌無力患者中展現了臨床意義和統計學顯著的MG-ADL（重症肌無力日常活動）評分，這是對重症肌無力症狀嚴重程度的衡量。
After two doses of Uplizna, MG-ADL score showed an overall improvement of -4.2, versus -1.9 placebo adjusted.
接受兩劑Uplizna後，MG-ADL評分顯示總體改善達到-4.2，而安慰劑調整爲-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.
該試驗表明，在定量重症肌無力（QMG）評分中存在顯著統計學改善，這是一種測量重症肌無力嚴重程度的臨床評估。
QMG score improvement with Uplizna compared to placebo at week 26 was -4.8 overall improvement compared to -2.5 placebo adjusted.
與安慰劑相比，Uplizna在第26周的QMG評分的改善爲-4.8，而安慰劑調整爲-2.5，總體改善。
No new safety signals were identified.
未發現新的安全信號。
STAT News noted that though the trials succeeded, the therapies did not beat existing competitors on the market.
STAt News指出，儘管試驗取得成功，但這些療法並未超越市場上現有的競爭對手。
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%接受賽諾菲安萬特（納斯達克:SNY）/Regeneraon Pharmaceuticals Inc（納斯達克:REGN）的Dupixent（dupilumab）的成年患者在SOLO 1試驗的第16周達到EASI-75，而安慰劑爲15%，在SOLO 2試驗中爲44%，而安慰劑爲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的數據沒有達到預期，引發了對其在日益競爭激烈的特應性皮炎市場中臨床表現如何的擔憂，尤其是在更爲廣泛的ROCKEt項目逐步展開之際。
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在重症肌無力方面的結果超出了William Blair的預期，表明該治療在市場上有着強大的潛力。其主要優勢包括用藥頻率較低，以及可能減少類固醇使用。
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).
焦點將放在確定Uplizna在重症肌無力治療領域的位置上，與FcRn、IVIg、補體抑制劑、利妥昔單抗等其他選擇一起。另外，Uplizna在自身免疫疾病中CD19靶向策略的潛力將受到密切關注，特別是與Cullinan Therapeutics, Inc.（納斯達克:CGEM）等競爭對手的比較。
Price Action: AMGN stock is trading lower by 2.09% to $324.04 at the last check on Wednesday.
股價走勢：AMGN股票在週三最後檢查時下跌2.09%，報324.04美元。
- Private Equity Firms Circle Sanofi's Consumer Health Business Amid Potential Spinoff.
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Photo via Shutterstock
圖片來自shutterstock。
譯文內容由第三人軟體翻譯。
