Lyra Therapeutics, Inc.

Lyra治疗公司

LYRA

里拉

released results on Monday from the ENLIGHTEN 2 Phase 3 trial of LYR-210 in adult patients with

周一公布了LYR-210在成年患者中进行的ENLIGHTEN 2 第三期试验的结果，

Chronic Rhinosinusitis (CRS)

慢性鼻窦炎 (CRS)

.

。

The ENLIGHTEN 2 trial met its primary endpoint, with LYR-210 demonstrating statistically significant improvement compared to sham control in a composite of the three cardinal symptoms (3CS) of CRS (nasal obstruction, nasal discharge, facial pain/pressure) at week 24 (p=0.0078) in patients without nasal polyps..

ENLIGHTEN 2 试验达到了其主要终点，在第 24 周时，LYR-210 在慢性鼻窦炎 (CRS) 的三个主要症状（鼻塞、流涕、面部疼痛/压力）的复合指标上，与假手术组相比显示出统计学上的显著改善 (p=0.0078)，适用于无鼻息肉患者。

Also Read:

另请阅读：

Amgen-AstraZeneca Partnered Asthma Drug Shows Rapid And Sustained Effect In Chronic Rhinosinusitis

安进-阿斯利康合作的哮喘药物在慢性鼻窦炎中显示出快速且持续的效果

The ENLIGHTEN 2 trial also met the key secondary endpoints of 3CS at 24 weeks in the full population (i.e., patients with and without nasal polyps) and in the clinically validated SNOT-22 score at 24 weeks, with symptom improvement

ENLIGHTEN 2 试验还达到了在全人群（即，有或没有鼻息肉的患者）中第 24 周时 3CS 的关键次要终点，以及在第 24 周时经过临床验证的 SNOT-22 评分的症状改善。

observed as early as week 4

早在第4周就观察到

.

。

Improvements in SNOT-22 were sustained throughout the trial and were clinically meaningful. More than twice the minimal clinically important difference was observed at week 24 compared to baseline in the LYR-210 group (-22.4 points).

SNOT-22的改善在试验期间一直保持，并且具有临床意义。在LYR-210组中，与基线相比，第24周时观察到的最小临床重要差异超过了两倍（-22.4点）。

Consistent with previous studies, LYR-210 was well-tolerated, with a safety profile similar to sham control.

与之前的研究一致，LYR-210 耐受性良好，其安全性与假手术对照组相似。

Data evaluating computed tomography (CT) scans demonstrated numerical improvement in ethmoid sinus opacification in patients who received LYR-210, compared to sham control at week 20 (-2.15; p=0.1809). These data provide objective radiological evidence of improvement with LYR-210 treatment.

评估计算机断层扫描 (CT) 的数据显示，与假手术对照组相比，接受 LYR-210 治疗的患者在第 20 周时筛窦混浊情况有数值上的改善 (-2.15；p=0.1809)。这些数据提供了 LYR-210 治疗改善的客观放射学证据。

LYR-210 patients showed no difference from sham patients in using corticosteroid rescue medication; however, the LYR-210 patients had fewer endoscopic sinus surgeries than sham control.

LYR-210组患者在使用皮质类固醇救援药物方面与假手术组患者无差异；然而，LYR-210组患者的内窥镜鼻窦手术次数比假手术对照组少。

LYR-210 was well tolerated, with no product-related serious adverse events in the ENLIGHTEN 2 trial.

LYR-210 在 ENLIGHTEN 2 试验中耐受性良好，无与产品相关的严重不良事件。

The ENLIGHTEN program consists of two Phase 3 trials, ENLIGHTEN 1 and ENLIGHTEN 2, to evaluate the efficacy and safety of LYR-210 for CRS.

ENLIGHTEN 计划包括两项三期试验，ENLIGHTEN 1 和 ENLIGHTEN 2，以评估 LYR-210 治疗 CRS 的有效性和安全性。

While the ENLIGHTEN 2 trial met its primary endpoint and key secondary endpoints, the ENLIGHTEN 1 trial did not meet the primary or secondary endpoints, as

虽然ENLIGHTEN 2试验达到了其主要终点和关键次要终点，但ENLIGHTEN 1试验并未达到主要或次要终点，因为

reported in May 2024

2024年5月报告

.

。

Lyra also conducted a pooled data analysis of 64 CRS patients with small nasal polyps (grade 1) from the ENLIGHTEN 1 and ENLIGHTEN 2 trials. The data demonstrated a consistent positive trend compared to sham control over 24 weeks in multiple endpoints:

Lyra还对来自ENLIGHTEN 1和ENLIGHTEN 2试验的64名小鼻息肉（1级）CRS患者进行了汇总数据分析。数据显示，在多个终点上，与假手术对照相比，在24周内表现出一致的积极趋势：

Improvement in 3CS with LYR-210 compared to sham control at week 24, starting as early as week 4.

与假手术对照组相比，使用LYR-210的3CS在第24周得到改善，最早在第4周开始。

Improvement in SNOT-22 score with LYR-210 compared to sham control at week 24, starting as early as week 4.

与假手术对照组相比，LYR-210在第24周时SNOT-22评分的改善，最早在第4周就开始显现。

Improvements in percent ethmoid opacification with LYR-210 compared to sham control at week 20.

与假手术对照组相比，使用LYR-210后第20周筛窦混浊百分比的改善情况。

Improvements in nasal congestion score (NCS) with LYR-210 compared to sham control at week 24 for patients with moderate to severe NCS at baseline, starting as early as week 4.

与假手术对照组相比，基线时中重度鼻塞评分（NCS）的患者在第24周时使用LYR-210改善了鼻塞评分（NCS），最早在第4周开始见效。

Improved nasal polyp score with LYR-210 compared to sham control at week 24.

与假手术对照组相比，LYR-210在第24周改善了鼻息肉评分。

In March, the Food and Drug Administration (FDA) accepted for review

今年三月，美国食品药品监督管理局（FDA）接受了审查

GSK plc's

葛兰素史克公司

GSK

葛兰素史克

marketing application for

营销应用

depemokimab in two indications

德普莫单抗用于两种适应症

:

：

Add-on maintenance treatment of asthma in adult and pediatric patients aged 12 years and older with type 2 inflammation characterized by an eosinophilic phenotype on medium- to high-dose inhaled corticosteroids (ICS) plus another asthma controller

用于12岁及以上、具有嗜酸性粒细胞表型的2型炎症哮喘成人和儿童患者的附加维持治疗，这些患者正在接受中至高剂量的吸入性糖皮质激素（ICS）加另一种哮喘控制药物。

Add-on maintenance treatment in adult patients with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP).

成人患者中未得到充分控制的慢性鼻窦炎伴鼻息肉（CRSwNP）的附加维持治疗。

Price Action:

价格行为：

LYRA stock is up 411.6% at $25.22 during the premarket session at the last check on Monday.

LYRA股票在周一最后一次检查时的盘前交易中上涨了411.6%，达到25.22美元。

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