AstraZeneca Unveils Early Data From Chinese-Firm Partnered Oral Weight Loss Drug
AstraZeneca Unveils Early Data From Chinese-Firm Partnered Oral Weight Loss Drug
At the ObesityWeek 2024, AstraZeneca Plc (NASDAQ:AZN) shared data abstracts highlighting early data from AZD5004/ECC5004.
在2024年的肥胖周（ObesityWeek），阿斯利康（AstraZeneca Plc，納斯達克股票代碼：AZN）分享了AZD5004/ECC5004的初步數據摘要。
In November 2023, AstraZeneca announced an exclusive license agreement with Eccogene for potential obesity treatment, ECC5004, an investigational oral once-daily glucagon-like peptide 1 receptor agonist.
2023年11月，阿斯利康宣佈與Eccogene簽訂獨家許可協議，用於潛在肥胖治療的候選藥物ECC5004，一種研究中的口服每日一次的類胰高血糖素樣肽-1受體激動劑。
Eccogene received an initial upfront payment of $185 million. In addition, Eccogene will also receive up to an additional $1.825 billion in future milestone payments.
Eccogene收到了首筆18500萬美元的初始支付。此外，Eccogene還將獲得未來里程碑付款，最高可達18.25億美元。
Also Read: AstraZeneca CEO Highlights Decade-Long Sales Goal Of $45B Along With Investor Doubts As It Lags In Weight Loss Race
閱讀更多：阿斯利康首席執行官強調450億美元的十年銷售目標，投資者對其在減肥比賽中落後表示懷疑
The company shared data from a double-blind, randomized, placebo-controlled study of ECC5004 in healthy participants in single doses (SAD) and participants with type 2 diabetes (T2DM) on metformin only and in multiple doses (MAD). The primary objective was to evaluate safety and tolerability.
該公司分享了一項關於ECC5004在健康參與者中單劑（SAD）和已接受二甲雙胍治療的2型糖尿病患者（T2DM）中多劑（MAD）的雙盲、隨機、安慰劑對照研究的數據。主要目標是評估安全性和耐受性。
In the SAD, 19 randomized participants received eight doses ranging from 1mg to 300mg.There were no serious adverse events (AEs), and gastrointestinal (GI) AEs were most common in doses ≥ 50mg.
在SAD中，有19名受試者被隨機分配，分別接受了從1毫克到300毫克不等的八種劑量。沒有發生嚴重不良事件（AEs），而胃腸道（GI）不良事件在劑量≥ 50毫克的情況下最爲常見。
Pharmacokinetic (PK) profiles demonstrated a linear profile and geometric mean half-life of between 11.06h (CV 14.2%) to 24.48h (CV 9.3%) and Tmax of 7.6h (CV 36.68) to 16.7 h (CV 101).
藥代動力學（PK）分析顯示出線性的特徵，幾何平均半衰期在11.06小時（14.2% CV）到24.48小時（9.3% CV）之間，達到最高血藥濃度的時間（Tmax）爲7.6小時（36.68% CV）到16.7小時（101% CV）。
The researchers note that this first-in-human study demonstrated that ECC5004 has a safety and tolerability profile consistent with that observed for other small molecule GLP-1RAs and a PK profile compatible with once-daily dosing.
研究人員指出，這項首次人體研究表明，ECC5004具有與觀察到的其他小分子GLP-1RAs類似的安全性和耐受性特徵，以及適合每日一次服用的PK特徵。
Changes in glucose levels and body weight suggest ECC5004 achieved target engagement of the GLP-1R.
葡萄糖水平和體重的變化表明ECC5004實現了與GLP-1R的目標識別。
Data from an open-label, randomized, single-dose cross-over study in 14 healthy participants under fasted/fed conditions showed that AZD5004/ECC5004 may be administered orally in the fasted or fed state as overall exposure and T1/2 are unaffected by food, suggesting that AZD5004/ECC5004 has the potential to be a more convenient, oral, once-daily therapy for patients.
在開放標籤、隨機、單劑量交叉研究中展示，14名健康受試者在空腹/進食條件下，AZD5004/ECC5004的數據顯示，可在空腹或進食狀態下口服，整體曝光和T1/2不受食物影響，暗示AZD5004/ECC5004有潛力成爲更便利的口服一日一次療法。
The researchers added that prolonged Tmax, and lower Cmax observed in the fed state have the potential to confer better tolerability, but this will need to be evaluated in larger and longer studies, which are currently in progress.
研究人員補充說，在進食狀態下觀察到的延長的Tmax和較低的Cmax有可能提供更好的耐受性，但這需要在當前正在進行的更大規模和更長期的研究中進行評估。
Price Action: AZN stock is up 0.04% at $71.45 at the last check on Monday.
股價走勢：AZN股票在週一最後一次檢查時上漲0.04%，報71.45美元。
- Disney Creates New Tech Hub For AI and AR
- 迪士尼爲人工智能和增強現實技術創建了新的科技中心
譯文內容由第三人軟體翻譯。
