Why Is Small-Cap Metabolic-Focused Rezolute Stock Trading Higher On Wednesday?
Why Is Small-Cap Metabolic-Focused Rezolute Stock Trading Higher On Wednesday?
Tuesday, Rezolute Inc (NASDAQ:RZLT) released topline results from the Phase 2 study of RZ402 in diabetic macular edema patients who are naïve to or have received limited anti-vascular growth factor (anti-VEGF) injections.
週二，Rezolute Inc（納斯達克股票代碼：RZLT）公佈了針對天真或接受過有限抗血管生長因子（抗VEGF）注射的糖尿病黃斑水腫患者的 RZ402 二期研究的主要結果。
94 participants were enrolled to evaluate the safety, efficacy, and pharmacokinetics of RZ402 administered as a monotherapy over a 12-week (three-month) treatment period.
招募了 94 名參與者，以評估在 12 周（三個月）治療期內作爲單一療法使用的 RZ402 的安全性、有效性和藥代動力學。
RZ402 met both primary endpoints of change in macular edema (central subfield thickness or CST) and a good safety profile.
RZ402 既符合黃斑水腫變化的主要終點（中央亞場厚度或 CST），又符合良好的安全性。
- CST improved significantly at all RZ402 dose levels compared to placebo (up to approximately 50 microns; p=0.02)
- Continued downward trajectory in CST over course of study and at the end of treatment.
- No significant difference between RZ402 dose levels, though the response was largest at the 200 mg dose.
- A sub-analysis by DME severity (CST ≥400 microns) indicates an improvement of approximately 75 microns at the 200 mg dose.
- CST declined in most patients who received the 200 mg dose of RZ402, including clinically significant improvements from baseline in more than 20% of participants, compared to none in placebo, with high rates of worsening.
- 與安慰劑相比，所有 RZ402 劑量水平的 CST 均顯著改善（最高約爲 50 微米；p=0.02）
- 在研究過程中和治療結束時，CST繼續呈下降趨勢。
- 儘管在 200 mg 劑量時反應最大，但 RZ402 劑量水平之間沒有顯著差異。
- 按二甲苯醚嚴重程度（CST ≥400 微米）進行的子分析表明，200 mg劑量的改善約爲75微米。
- 大多數接受 200 mg 劑量 RZ402 的患者的 CST 均有所下降，包括超過 20% 的參與者與基線相比臨床顯著改善，而安慰劑爲零，惡化率很高。
RZ402 was safe and well-tolerated. Adverse events (AEs) were generally mild, and rates were comparable to placebo.
RZ402 安全且耐受性良好。不良事件（AE）通常較輕，發生率與安慰劑相當。
- No ocular adverse effects that are typically seen with intravitreal injections were observed.
- Target concentrations were exceeded at all three doses and continued supporting once-daily oral dosing.
- 未觀察到玻璃體內注射通常出現的眼部不良反應。
- 所有三劑量均超過目標濃度，並繼續支持每日一次口服給藥。
No significant improvements in Best Corrected Visual Acuity (BCVA) compared to placebo.
與安慰劑相比，最佳矯正視力（BCVA）沒有顯著改善。
- In line with expectations for a study of this duration
- Observed improvements in CST would predict visual improvements in a longer-duration study.
- 符合對這段時間研究的預期
- 觀測到的CST改善將預測持續時間較長的研究的視覺改善。
Five RZ402-treated participants at 200 mg (20%) experienced a one-step improvement in the Diabetic Retinopathy Severity Score (DRSS) compared to one participant in placebo.
與一名接受安慰劑的參與者相比，五名接受了200 mg（20%）的RZ402治療參與者的糖尿病視網膜病變嚴重程度評分（DRSS）得到了一步改善。
Price Action: At the last check on Wednesday, RZLT shares were up 31.3% at $3.94 during the premarket session.
價格走勢：在週三的最後一次檢查中，RZLT股價在盤前交易時段上漲了31.3％，至3.94美元。
譯文內容由第三人軟體翻譯。