Why Is Diabetes-Drug Developer Biomea Fusion Stock Trading Lower On Tuesday?
Why Is Diabetes-Drug Developer Biomea Fusion Stock Trading Lower On Tuesday?
The study showed positive topline results at Week 26, demonstrating statistically significant and clinically meaningful reductions in HbA1c, the gold standard for assessing glycemic control in T2D.On Tuesday, Biomea Fusion Inc. (NASDAQ:BMEA) revealed topline results from the ongoing COVALENT-111 study of icovamenib in patients with type 2 diabetes (T2D).
在週二，Biomea Fusion Inc.（納斯達克：BMEA）公佈了正在進行的COVALENt-111研究中icovamenib在2型糖尿病（T2D）患者中的頂線結果。
Icovamenib was investigated in three different dosing arms with a primary follow-up after 26 weeks: Arm A at 100mg QD (once daily) for 8 weeks, Arm B at 100mg QD for 12 weeks, and Arm C at 100 mg QD for 8 weeks and 100mg BID (twice daily) for 4 weeks.
icovamenib在三個不同劑量組中進行研究，主要隨訪在26周後：A組在8周內每天100mg，B組在12周內每天100mg，C組在8周內每天100mg和4周內每天100mg兩次。
Also Read: FDA Removes Clinical Hold On Biomea Fusion's Early-Stage Trials For Potential Diabetes Candidate
還閱讀：FDA解除對Biomea Fusion潛在糖尿病候選藥物早期試驗的臨床持有。
The study showed positive topline results at Week 26, demonstrating statistically significant and clinically meaningful reductions in HbA1c, the gold standard for assessing glycemic control in T2D.
研究在第26周顯示積極的頂線結果，表明HbA1c有統計學顯著性和臨床意義的減少，這是評估T2D血糖控制的黃金標準。
Patients who completed dosing per the protocol and were suboptimally controlled at baseline on one or more prior agents, icovamenib, showed meaningful reductions in HbA1c with statistical significance in all major categories.
根據方案完成給藥的患者，在基線時在一種或多種先前藥物上控制不佳的情況下，icovamenib顯示HbA1c有意義的減少，並在所有主要類別中具有統計學顯著性。
Here, icovamenib showed a mean reduction in HbA1c of 0.36% (p=0.022). Arm B (icovamenib dosed at 100mg QD for 12 weeks) was the strongest performing arm with a mean HbA1c reduction of 0.5% (p=0.012).
在這裏，icovamenib顯示HbA1c平均減少0.36%（p=0.022）。B組（icovamenib在12周內每天100mg給藥）是表現最強的組，HbA1c平均減少0.5%（p=0.012）。
In the analysis of the T2D phenotypes, icovamenib showed further improved reduction in insulin-deficient patients.
在對T2D表型的分析中，icovamenib在胰島素缺乏患者中顯示出進一步改善的減量。
Within the mild age-related diabetes (MARD) and severe insulin-deficient diabetes (SIDD) patients, the mean HbA1c reduction was 0.73%, and in Arm B, these patient subtypes reduced the mean HbA1c by 1.05%.
在輕度年齡相關糖尿病（MARD）和嚴重胰島素缺乏糖尿病（SIDD）患者中，HbA1c的平均減少爲0.73%，在B組，這些患者亞型使HbA1c平均減少1.05%。
The patients who were considered most severely insulin deficient, the SIDDs, demonstrated the best response with a mean HbA1c reduction in Arm B of 1.47%.
被認爲胰島素嚴重缺乏的患者，即SIDDs，在b組的HbA1c平均降低了1.47%，反應最佳。
Of note, in the patients who failed on a GLP-1-based therapy, an HbA1c reduction of 0.84% was demonstrated.
值得注意的是，在GLP-1治療失敗的患者中，HbA1c降低了0.84%。
No serious adverse events or discontinuations due to adverse events were observed.
觀察到沒有嚴重的不良事件或因不良事件而中斷的情況。
No drug-to-drug interactions were observed during the study. Overall, icovamenib was well tolerated and demonstrated a favorable safety profile in the COVALENT-111 study.
在研究期間沒有觀察到藥物間的相互作用。總體而言，icovamenib耐受性良好，並在COVALENt-111研究中表現出良好的安全性特徵。
Price Action: BMEA stock is down 14.50% at $5.01 at the last check on Tuesday.
價格走勢：BMEA股票在週二最後一次檢查時下跌了14.50%，報5.01美元。
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譯文內容由第三人軟體翻譯。
