What's Going In With Vivek Ramaswamy-Founded Roivant Sciences Stock On Monday?
What's Going In With Vivek Ramaswamy-Founded Roivant Sciences Stock On Monday?
As previously disclosed, the batoclimab phase 2a trial in uncontrolled Graves' Disease enrolled patients who were hyperthyroid despite antithyroid drugs (ATD) therapy.Monday, Immunovant, Inc. (NASDAQ:IMVT) reported results from the Phase 2a trial of batoclimab in Graves' Disease, an immune system condition that affects the thyroid gland. It causes the body to make too much thyroid hormone.
週一，Immunovant, Inc.（納斯達克股票代碼：IMVT）公佈了巴托克利單抗治療格雷夫斯病的2a期試驗結果，格雷夫斯病是一種影響甲狀腺的免疫系統疾病。它會導致人體產生過多的甲狀腺激素。
Immunovant is a member of the Roivant Sciences Ltd. (NASDAQ:ROIV) family of companies.
Immunovant是Roivant Sciences Ltd.（納斯達克股票代碼：ROIV）家族公司的成員。
Also Read: Vivek Ramaswamy-Founded Roivant's Anti-Inflammatory Drug Aces Mid-Stage Study.
另請閱讀：維維克·拉馬斯瓦米創立的Roivant的抗炎藥物在中期研究中脫穎而出。
As previously disclosed, the batoclimab phase 2a trial in uncontrolled Graves' Disease enrolled patients who were hyperthyroid despite antithyroid drugs (ATD) therapy.
正如先前披露的那樣，針對不受控制的格雷夫斯病的batoclimab2a期試驗招收了儘管接受抗甲狀腺藥物（ATD）治療後仍出現甲狀腺功能亢進的患者。
Participants in the trial received 12 weeks of high-dose batoclimab, 680 mg weekly by subcutaneous injection (SC) followed by 12 weeks of lower-dose batoclimab, 340 mg weekly SC.
該試驗的參與者接受了爲期12周的高劑量巴托克利單抗，每週接受680毫克皮下注射（SC），隨後接受了12周的低劑量巴托克利單抗，每週服用340毫克。
At the end of the first 12 weeks, participants experienced a mean IgG reduction of 77%, leading to a 76% Response rate.
在前12周結束時，參與者的平均IgG減少了77％，反應率爲76％。
In addition, by the end of 12 weeks of higher dose batoclimab, 56% achieved an ATD-Free Response.
此外，到更高劑量的巴托克利單抗12周結束時，有56％的人實現了無ATD反應。
Despite benefiting from a lower starting IgG level after 12 weeks of 680mg therapy, during Weeks 13 to 24, the lower 340mg dose of batoclimab resulted in a mean IgG reduction of 65% (vs. 77% on 680mg dose) with a corresponding lower responder rate of 68%.
儘管在接受680mg治療12周後受益於較低的起始IgG水平，但在第13至24週期間，較低的340mg劑量的巴托克利單抗導致平均IgG降低了65％（而680mg劑量的77％），相應的緩解率較低，爲68％。
In the second 12 weeks, a 36% lower ATD-Free Response rate was also observed.
在接下來的12週中，還觀察到無ATD反應率降低了36％。
Finally, patients who achieved at least a 70% IgG reduction at the end of the trial had nearly a threefold higher ATD-Free Response rate than those who did not (60% vs. 23%).
最後，在試驗結束時達到至少 70% IgG 降低的患者的無ATD反應率比未降低 70% 的患者高出近三倍（60% 對 23%）。
"We find the correlation between clinical response and IgG lowering impressive and believe this creates not only a potential first-in-class but also a potential best-in-class opportunity for IMVT-1402. We are very pleased to have aligned with the FDA on a pivotal trial design that we expect to initiate by the end of the year," said Pete Salzmann, CEO of Immunovant.
“我們發現臨床反應與IgG降低之間的相關性令人印象深刻，並相信這不僅爲IMVT-1402創造了潛在的同類首創機會，而且還創造了潛在的同類最佳機會。Immunovant首席執行官皮特·薩爾茲曼說，我們很高興與美國食品藥品管理局就一項關鍵試驗設計達成一致，我們預計該設計將於今年年底啓動。
Immunovant also announced alignment with the FDA and Investigational New Drug Application clearance, with the initiation of a pivotal trial of IMVT-1402 in Graves' Disease expected by December 31, 2024.
Immunovant還宣佈與美國食品藥品管理局和研究性新藥申請許可保持一致，預計將於2024年12月31日啓動一項針對格雷夫斯病的IMVT-1402的關鍵試驗。
Price Action: ROIV stock is up 4.67% at $12.88, and IMVT stock is down 0.32% at $33.92 at last check Monday.
價格走勢：週一最後一次查看時，ROIV股價上漲4.67％，至12.88美元，imVT股價下跌0.32％，至33.92美元。
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譯文內容由第三人軟體翻譯。
