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).
週二，Biomea Fusion Inc.（納斯達克股票代碼：BMEA）公佈了正在進行的Covamenib在2型糖尿病（T2D）患者中進行的Covamenib研究的主要結果。
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在三個不同的劑量組中進行了研究，26周後進行了主要隨訪：A組爲100mg QD（每天一次），持續8周；組b爲100mg QD，持續12周；C組爲100 mg QD，持續8周，BID爲100mg（每日兩次），持續4周。
Also Read: FDA Removes Clinical Hold On Biomea Fusion's Early-Stage Trials For Potential Diabetes Candidate
另請閱讀：美國食品藥品管理局取消了對Biomea Fusion針對潛在糖尿病候選物的早期試驗的臨牀擱置
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.
該研究在第26周顯示出積極的頂線結果，表明HbA1c下降具有統計學意義和臨牀意義，HbA1c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.
根據方案完成給藥並在基線時接受過一種或多種先前藥物icovamenib控制不佳的患者，其HbA1c在所有主要類別中均有顯著降低，具有統計學意義。
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的平均降幅爲0.36％（p=0.022）。b組（icovamenib 的劑量爲100mg QD，持續12周）是表現最強的組，平均HbA1c降低了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顯示胰島素缺乏患者的降幅進一步改善。
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%.
在輕度年齡相關性糖尿病（MARD）和嚴重胰島素缺乏糖尿病（SIDD）患者中，平均HbA1c降低了0.73％，而在b組中，這些患者亞型將平均HbA1c降低了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%.
被認爲是胰島素缺乏最嚴重的患者SIDDs表現出最佳反應，Arm b的HbA1c平均降幅爲1.47％。
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，在基於GLP-1的治療失敗的患者中，HbA1c降低了0.84％。
No serious adverse events or discontinuations due to adverse events were observed.
未觀察到嚴重的不良事件或因不良事件而停藥。
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.
研究期間未觀察到藥物間的相互作用。總體而言，icovamenib的耐受性良好，在Covalent-111研究中表現出良好的安全性。
Price Action: BMEA stock is down 14.50% at $5.01 at the last check on Tuesday.
價格走勢：在週二的最後一次支票中，BMEA股價下跌14.50％，至5.01美元。
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