As soon as favorable topline results from a clinical study was released, the stock price of Rezolute, Inc. (NASDAQ: RZLT) shot up on US stock charts. RZLT shares gained 46.33% to $4.39 in after-hours trading. That followed a 6.76% in the stock price to close the regular session at $3.00.
- Clinical Study Insights
- Study Design And Results
- Future Directions
Clinical Study Insights
Rezolute (RZLT) presented promising findings from the RZ402 Phase 2 study, which managed DME patients treated with injections of anti-vascular endothelial growth factor (anti-VEGF) either seldom or not at all.
The research's results, which demonstrate a significant decrease in central subfield thickness (CST) in all three dosing groups, are highly noteworthy for the DME community. For DME patients, CST is an essential biomarker for evaluating the possible advantages of a treatment. The promise of RZ402 as a new, non-invasive first-line therapy for DME is supported by these data.
Study Design And Results
The U.S.-based multi-center, randomized, double-masked, placebo-controlled, parallel-arm study enrolled 94 participants. This research was out to assess the pharmacokinetics, safety, and effectiveness of RZ402 when used as a monotherapy for the duration of the 12-week treatment regimen.
Following a four-week follow-up period, participants were randomized to receive one of three doses of RZ402 including 50 mg, 200 mg, or 400 mg; or a placebo, provided once daily. It was anticipated that there would be no appreciable increases in best-corrected visual acuity (BCVA) over placebo given the length of the research.
However, improvements in CST were observed, indicating potential for visual improvements in longer-term studies. Additionally, five participants treated with RZ402 exhibited a one-step improvement in the Diabetic Retinopathy Severity Score (DRSS) compared to one participant in the placebo group.
Future Directions
Rezolute plans to present these encouraging data and additional findings at an upcoming medical conference. The potential for an oral therapy to treat DME is particularly exciting, as it could enable earlier intervention and treatment of both eyes, possibly altering the long-term prognosis for DME patients.
臨床研究的有利結果一發布，Rezolute, Inc.（納斯達克股票代碼：RZLT）的股價就在美國股市上漲。盤後交易中，RZLT股價上漲46.33％，至4.39美元。在此之前，股價上漲6.76％，常會收於3.00美元。
臨床研究見解
Rezolute（RZLT）介紹了RZ402 2期研究的令人鼓舞的發現，該研究管理了很少或根本沒有注射抗血管內皮生長因子（抗血管內皮生長因子）治療的DME患者。
該研究的結果表明，所有三個給藥組的中心子場厚度（CST）均顯著降低，這對DME社區來說非常值得關注。對於DME患者來說，CST是評估治療可能優勢的必不可少的生物標誌物。這些數據支持了 RZ402 作爲一種新的非侵入性 DME 一線療法的前景。
研究設計和結果
這項總部位於美國的多中心、隨機、雙面罩、安慰劑對照、平行臂研究招收了94名參與者。這項研究旨在評估 RZ402 在 12 周的治療方案中用作單一療法時的藥代動力學、安全性和有效性。
經過四周的隨訪期，參與者被隨機分配接受三劑 RZ402 中的一劑，包括 50 mg、200 mg 或 400 mg；或安慰劑，每天提供一次。鑑於研究的持續時間，預計最佳矯正視力（BCVA）與安慰劑相比不會有明顯提高。
但是，觀察到CST有所改善，這表明在長期研究中，視覺效果有可能得到改善。此外，與安慰劑組的一名參與者相比，五名接受 RZ402 治療的參與者的糖尿病視網膜病變嚴重程度評分 (DRSS) 改善了一步。
未來方向
Rezolute計劃在即將舉行的醫學會議上介紹這些令人鼓舞的數據和其他發現。口服療法治療DME的潛力尤其令人興奮，因爲它可以更早地進行雙眼乾預和治療，從而可能改變DME患者的長期預後。
