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Why Is Small-Cap Metabolic-Focused Rezolute Stock Trading Higher On Wednesday?

Why Is Small-Cap Metabolic-Focused Rezolute Stock Trading Higher On Wednesday?

爲什麼以代謝爲重點的小盤股Rezolute股票週三交易走高?
Benzinga ·  05/22 19:56

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。


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