WATERTOWN, Mass., June 02, 2025 (GLOBE NEWSWIRE) -- Lyra Therapeutics, Inc. (Nasdaq: LYRA) (“Lyra” or the “Company”), a clinical-stage biotechnology company developing long-acting, anti-inflammatory sinonasal implants for the treatment of chronic rhinosinusitis (CRS), today announced positive results from the ENLIGHTEN 2 Phase 3 clinical trial of LYR-210 in adult patients with CRS.

马萨诸塞州沃特敦，2025年6月2日（环球新闻社）——Lyra Therapeutics, Inc.（纳斯达克股票代码：LYRA）（“Lyra”或“公司”），一家临床阶段的生物技术公司，致力于开发用于治疗慢性鼻窦炎（CRS）的长效抗炎鼻窦植入物，今天宣布了ENLIGHTEN 2 III期临床试验中LYR-210在成年CRS患者中的积极结果。

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 (-1.13; p=0.0078) in patients without nasal polyps..

ENLIGHTEN 2 试验达到了主要终点，LYR-210 在第 24 周时，在无鼻息肉患者的慢性鼻窦炎 (CRS) 三大主要症状（3CS）综合指标（鼻塞、流涕、面部疼痛/压迫感）上，与假手术对照组相比表现出统计学上的显著改善（-1.13；p=0.0078）。

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) (-0.90; p=0.0209) and in the clinically-validated SNOT-22 score at 24 weeks (-8.7; p=0.0101), with symptom improvement observed as early as week 4. Consistent with previous studies, LYR-210 was well-tolerated, with a safety profile similar to sham control..

ENLIGHTEN 2 试验还达到了在全人群（即有或没有鼻息肉的患者）中 24 周时 3CS 的关键次要终点（-0.90；p=0.0209），以及在 24 周时经过临床验证的 SNOT-22 评分的关键次要终点（-8.7；p=0.0101），症状改善最早在第 4 周就已观察到。与之前的研究一致，LYR-210 耐受性良好，其安全性与假手术组相似。

The ENLIGHTEN program consists of two Phase 3 clinical trials, ENLIGHTEN 1 and ENLIGHTEN 2, to evaluate the efficacy and safety of LYR-210 for the treatment of CRS. While the ENLIGHTEN 2 trial met its primary endpoint and key secondary endpoints, the ENLIGHTEN 1 trial did not meet the primary endpoint or secondary endpoints, as previously reported in May 2024.

ENLIGHTEN 项目包含两项三期临床试验，即 ENLIGHTEN 1 和 ENLIGHTEN 2，旨在评估 LYR-210 治疗 CRS 的有效性和安全性。尽管 ENLIGHTEN 2 试验达到了其主要终点和关键次要终点，但 ENLIGHTEN 1 试验未能达到主要终点或次要终点，正如 2024 年 5 月之前所报道的那样。

Each ENLIGHTEN trial has enrolled approximately 180 CRS patients who have failed medical management and have not had prior ethmoid sinus surgery, randomized 2:1 to either LYR-210 (7500µg mometasone furoate) or sham control. The 24-week endpoints in the ENLIGHTEN trials assess LYR-210’s long-acting therapeutic effect as a bioresorbable nasal implant designed to deliver six months of continuous anti-inflammatory medication to the sinonasal passages..

每个ENLIGHTEN试验已招募了大约180名药物治疗失败且未接受过筛窦手术的CRS患者，随机以2:1的比例分配至LYR-210（7500微克糠酸莫米松）或假手术对照组。ENLIGHTEN试验的24周终点评估LYR-210作为一种可生物吸收的鼻腔植入物的长效治疗效果，该植入物旨在为鼻窦通道提供连续六个月的抗炎药物。

Results for Primary and Key Secondary Endpoints from ENLIGHTEN 2 Phase 3 Trial

ENLIGHTEN 2 第三期试验的主要和关键次要终点结果

Patients reported LYR-210 significantly improved important outcome measures on primary and key secondary endpoints:

患者报告称，LYR-210 在主要和关键次要终点上显著改善了重要结果指标：

LYR-210 was well tolerated, with no product-related serious adverse events in the ENLIGHTEN 2 trial. The most commonly reported adverse events included epistaxis, upper respiratory tract infection, chronic sinusitis, acute sinusitis, nasopharyngitis, COVID-19, and headache.

LYR-210 在 ENLIGHTEN 2 试验中耐受性良好，未发生与产品相关的严重不良事件。最常见的不良事件包括鼻出血、上呼吸道感染、慢性鼻窦炎、急性鼻窦炎、鼻咽炎、新冠肺炎和头痛。

Results for CRS Patents with Nasal Polyps in Pooled Analysis from ENLIGHTEN 1 and ENLIGHTEN 2

ENLIGHTEN 1 和 ENLIGHTEN 2 汇总分析中伴有鼻息肉的 CRS 专利结果

Additionally, Lyra conducted a pooled data analysis of a total 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:

此外，Lyra 对来自ENLIGHTEN 1和ENLIGHTEN 2试验的总共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周内呈现出一致的积极趋势：

'We are thrilled to announce these positive results from our ENLIGHTEN 2 trial. We believe this has the potential to provide a path to advance LYR-210 to treat CRS, offering six months of therapy in a single administration for millions of patients who do not respond to standard CRS medical management.

“我们很高兴宣布ENLIGHTEN 2试验取得了这些积极的结果。我们相信这有潜力为推进LYR-210治疗CRS提供途径，为数百万对标准CRS药物治疗无反应的患者提供单次给药长达六个月的治疗。

We will continue to review the totality of the dataset from the ENLIGHTEN trials to optimize our regulatory strategy,” said Maria Palasis, Ph.D., President and CEO, Lyra Therapeutics. “Given these data we reported today, we plan to align with the FDA on a path forward for an NDA submission in patients without nasal polyps.

“我们将继续审查来自ENLIGHTEN试验的全部数据集，以优化我们的监管策略，”Lyra Therapeutics总裁兼首席执行官Maria Palasis博士说。“根据我们今天报告的数据，我们计划与FDA就针对无鼻息肉患者的NDA提交途径达成一致。”

As planned, we also analyzed the pooled data from ENLIGHTEN 2 and ENLIGHTEN 1 trials to treat CRS patients with nasal polyps, and we believe this positive data positions us to proceed with a development plan in patients with nasal polyps, based on our alignment in December 2024 with FDA on endpoints, inclusion criteria, patient population, background therapy, and assessments.

按照计划，我们还分析了ENLIGHTEN 2和ENLIGHTEN 1试验的汇总数据，以治疗伴有鼻息肉的CRS患者，我们认为这些积极的数据使我们能够根据2024年12月与FDA就终点指标、纳入标准、患者群体、背景疗法和评估达成的一致，推进针对鼻息肉患者的开发计划。

Looking further ahead, we envision LYR-210 achieving its potential to benefit both non-polyp and polyp patients, positioning us to become a leader in CRS and validating our platform for future ENT indications.”.

展望未来，我们预计LYR-210将充分发挥其潜力，惠及非息肉和息肉患者，使我们有望成为CRS领域的领导者，并验证我们平台在未来耳鼻喉科适应症中的应用。”

“The positive results seen in the ENLIGHTEN 2 study are impressive and represent what could be a promising new treatment approach for the many CRS patients that I see every day in my practice who are underserved by limited therapies,” said Zachary Soler, M.D., MSc, Professor in the Department of Otolaryngology-Head and Neck Surgery at the Medical University of South Carolina and coordinating Lead Investigator for the ENLIGHTEN 2 trial.

“ENLIGHTEN 2 研究中看到的积极结果令人印象深刻，这可能代表了一种很有前景的新治疗方式，可应用于我每天在诊所中接触到的许多 CRS 患者，这些患者因治疗手段有限而未能得到充分治疗，”南卡罗来纳医科大学耳鼻喉科-头颈外科系教授、ENLIGHTEN 2 试验的协调首席研究员扎卡里·索勒 (Zachary Soler) 医学博士、理学硕士表示。

“The more than 20-point improvement from baseline in SNOT-22 score after LYR-210 treatment represents a clinically meaningful improvement in patient symptoms.”.

“LYR-210治疗后，SNOT-22评分从基线提高了20多分，这代表着患者症状获得了有临床意义的改善。”

“These positive results represent a significant milestone in advancing an innovative treatment to CRS patients who suffer from this chronic condition. It's a proud moment for us and a testament to the dedication of this team and our investigators in the development of this novel therapy,” said Harlan Waksal, M.D., Executive Chairman, Lyra Therapeutics..

Results from the ENLIGHTEN 2 trial of LYR-210 are planned to be presented at the 71

LYR-210的ENLIGHTEN 2试验结果计划在第71届会议上展示。

st

开始

Annual Meeting of the American Rhinologic Society, October 2025.

美国鼻科学会年会，2025年10月。

About LYR-210

关于LYR-210

LYR-210 is an investigational product candidate for the treatment of chronic rhinosinusitis (CRS) in patients who have failed current therapies and require further intervention. LYR-210 is a bioabsorbable nasal implant designed to be inserted in a simple, in-office procedure. LYR-210 is intended to deliver six months of continuous anti-inflammatory therapy, mometasone furoate, to the sinonasal passages to treat CRS..

LYR-210 是一种用于治疗慢性鼻窦炎 (CRS) 的研究性产品候选药物，针对当前疗法无效且需要进一步干预的患者。LYR-210 是一种可生物吸收的鼻腔植入物，设计为通过简单的门诊手术插入。LYR-210 旨在为鼻窦通道提供连续六个月的抗炎治疗，释放糠酸莫米松以治疗慢性鼻窦炎。

About Lyra Therapeutics

关于Lyra Therapeutics

Lyra Therapeutics, Inc. is a clinical-stage biotechnology company developing long-acting, anti-inflammatory sinonasal implants for the treatment of chronic rhinosinusitis (CRS). Lyra Therapeutics is developing therapies for CRS, a highly prevalent inflammatory disease of the paranasal sinuses which leads to debilitating symptoms and significant morbidities.

Lyra Therapeutics, Inc. 是一家临床阶段的生物技术公司，正在开发用于治疗慢性鼻窦炎 (CRS) 的长效抗炎鼻窦植入物。Lyra Therapeutics 正在开发针对 CRS 的疗法，CRS 是一种高发的鼻旁窦炎症疾病，会导致令人虚弱的症状和严重的并发症。

LYR-210, the company’s lead product, is a bioabsorbable nasal implant designed to be administered in a simple, in-office procedure and is intended to deliver six months of continuous anti-inflammatory drug therapy (7500µg mometasone furoate) to the sinonasal passages for the treatment of CRS with a single administration.

LYR-210是该公司的主要产品，是一种可生物吸收的鼻腔植入物，设计用于在简单的门诊手术中进行给药。通过单次给药，它旨在为鼻窦通道提供六个月的持续抗炎药物治疗（7500微克糠酸莫米松），用于治疗慢性鼻窦炎（CRS）。

LYR-210, which was evaluated in the ENLIGHTEN Phase 3 clinical program, is intended for patients with and without nasal polyps. The company’s therapies are intended to treat the estimated four million CRS patients in the United States who fail medical management each year. For more information, please visit www.lyratx.com and follow us on LinkedIn..

LYR-210 是在 ENLIGHTEN 第三阶段临床项目中评估的药物，适用于有或没有鼻息肉的患者。该公司的治疗方法旨在治疗美国每年约四百万名未能通过药物管理的慢性鼻窦炎 (CRS) 患者。欲了解更多信息，请访问 www.lyratx.com 并在 LinkedIn 上关注我们。

Forward-Looking Statements

前瞻性声明

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The words “believe,” “may,” “will,” “estimate,” “envision,” “continue,” “anticipate,” “intend,” “expect,” and similar expressions are intended to identify forward-looking statements.

本新闻稿包含1995年《私人证券诉讼改革法案》所指的前瞻性陈述。 “相信”、“可能”、“将”、“估计”、“设想”、“继续”、“预期”、“打算”、“期望”等词语及类似表述旨在识别前瞻性陈述。

All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including statements regarding our evaluation and investigation of the ENLIGHTEN 2 results and how they inform our path forward, our planned regulatory interaction and path for LYR-210, including alignment with the FDA and any planned regulatory submissions, our ability to design, implement and complete a new Phase 3 trial, the expected label for LYR-210, whether the pooled results from ENLIGHTEN 1 and 2 would support a path forward to a pivotal study in CRSwNP, our ability to correctly interpret FDA guidance received in December 2024 including on endpoints, inclusion criteria, patient population, background therapy, and assessments, whether LYR-210, if advanced, would be positioned to align with current ENT practices, and statements regarding the potential market opportunity for LYR-210, our participation in future events and presentations, and the timing of any of the foregoing.

本新闻稿中所有不涉及历史事实的陈述均应视为前瞻性陈述，包括关于我们对ENLIGHTEN 2结果的评估和调查及其对我们未来路径的影响、我们对LYR-210的计划监管互动和路径（包括与FDA的协调及任何计划中的监管提交）、我们设计、实施和完成新的III期试验的能力、LYR-210的预期标签、来自ENLIGHTEN 1和2的汇总结果是否支持在CRSwNP中推进关键性研究、我们正确解读2024年12月收到的FDA指导的能力（包括终点、纳入标准、患者人群、背景治疗和评估）、如果LYR-210得以推进是否能够与当前耳鼻喉科实践保持一致、关于LYR-210潜在市场机会的陈述、我们参与未来活动和报告的情况、以及上述事项的时间安排等。

These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause the Company's actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: the Company’s failure to meet its primary endpoint in its E.

这些声明既不是承诺也不是保证，而是涉及已知和未知的风险、不确定性以及其他重要因素，这些因素可能导致公司的实际结果、业绩或成就与前瞻性声明中明示或暗示的任何未来结果、业绩或成就存在重大差异，包括但不限于以下事项：公司未能在其E项目中达到主要终点。

Source: Lyra Therapeutics, Inc.

来源：Lyra Therapeutics, Inc.

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