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.
周二，Rezolute Inc（纳斯达克股票代码：RZLT）公布了针对天真或接受过有限抗血管生长因子（抗VEGF）注射的糖尿病黄斑水肿患者的 RZ402 二期研究的主要结果。
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 名参与者，以评估在 12 周（三个月）治疗期内作为单一疗法使用的 RZ402 的安全性、有效性和药代动力学。
RZ402 met both primary endpoints of change in macular edema (central subfield thickness or CST) and a good safety profile.
RZ402 既符合黄斑水肿变化的主要终点（中央亚场厚度或 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.
- 与安慰剂相比，所有 RZ402 剂量水平的 CST 均显著改善（最高约为 50 微米；p=0.02）
- 在研究过程中和治疗结束时，CST继续呈下降趋势。
- 尽管在 200 mg 剂量时反应最大，但 RZ402 剂量水平之间没有显著差异。
- 按二甲苯醚严重程度（CST ≥400 微米）进行的子分析表明，200 mg剂量的改善约为75微米。
- 大多数接受 200 mg 剂量 RZ402 的患者的 CST 均有所下降，包括超过 20% 的参与者与基线相比临床显著改善，而安慰剂为零，恶化率很高。
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）通常较轻，发生率与安慰剂相当。
- 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.
- 未观察到玻璃体内注射通常出现的眼部不良反应。
- 所有三剂量均超过目标浓度，并继续支持每日一次口服给药。
No significant improvements in Best Corrected Visual Acuity (BCVA) compared to placebo.
与安慰剂相比，最佳矫正视力（BCVA）没有显著改善。
- In line with expectations for a study of this duration
- Observed improvements in CST would predict visual improvements in a longer-duration study.
- 符合对这段时间研究的预期
- 观测到的CST改善将预测持续时间较长的研究的视觉改善。
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.
与一名接受安慰剂的参与者相比，五名接受了200 mg（20%）的RZ402治疗参与者的糖尿病视网膜病变严重程度评分（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.
价格走势：在周三的最后一次检查中，RZLT股价在盘前交易时段上涨了31.3％，至3.94美元。
译文内容由第三方软件翻译。