ENLIGHTEN 1 trial did not meet its primary endpoint

启蒙1号试验未达到其主要终点

Company plans to evaluate full dataset and path forward

公司计划评估完整的数据集和前进的道路

WATERTOWN, Mass., May 06, 2024 (GLOBE NEWSWIRE) -- Lyra Therapeutics, Inc. (Nasdaq: LYRA) (“Lyra” or the “Company”), today announced topline results from the Company’s Phase 3 ENLIGHTEN 1 trial evaluating LYR-210 for the treatment of chronic rhinosinusitis (CRS). ENLIGHTEN 1 did not meet its primary endpoint of demonstrating statistically significant improvement compared to sham control in the composite score of the three cardinal symptoms (3CS) of CRS (nasal obstruction, nasal discharge, facial pain/pressure) at 24 weeks.

马萨诸塞州沃特敦，2024年5月6日（环球通讯社）--Lyra Therapeutics，Inc.（纳斯达克：Lyra）（“Lyra”或“公司”）今天宣布了该公司评估LYR-210治疗慢性鼻-鼻窦炎（CRS）的第3阶段启蒙1试验的结果。在24周时，在CRS（鼻塞，鼻涕，面部疼痛/压力）的三种主要症状（3CS）的综合评分中，与假对照组相比，启蒙1没有达到其主要终点，即显示出统计学上显着的改善。

ENLIGHTEN 1 is one of two Phase 3 clinical trials evaluating LYR-210, a bioabsorbable sinonasal implant (7500µg mometasone furoate), as a six-month treatment for chronic rhinosinusitis (CRS)..

启蒙1是评估LYR-210（一种生物可吸收的鼻窦植入物（7500µg糠酸莫米松））作为慢性鼻-鼻窦炎（CRS）六个月治疗的两项3期临床试验之一。。

“We are surprised and disappointed by the ENLIGHTEN 1 topline results,” said Maria Palasis, Ph.D., President and Chief Executive Officer, Lyra Therapeutics. “We are moving as quickly as possible to evaluate the full dataset to better understand these findings in order to determine our path forward.”.

Lyra Therapeutics总裁兼首席执行官Maria Palasis博士说：“我们对启蒙1的最终结果感到惊讶和失望。”。“我们正在尽快评估完整的数据集，以更好地了解这些发现，从而确定我们的前进道路。”。

At 24 weeks, the ENLIGHTEN 1 trial demonstrated the following results compared to baseline, which did not achieve statistical significance:

在24周时，与基线相比，启蒙1试验显示出以下结果，但没有达到统计学意义：

In the primary efficacy analysis, treatment with LYR-210 resulted in a mean (standard deviation; SD) improvement in the 3CS score of 2.13 (2.17) points, compared to 2.06 (2.14) points in sham control.

在主要疗效分析中，LYR-210治疗导致3CS评分平均（标准差；SD）改善2.13（2.17）分，而假对照组为2.06（2.14）分。

In the intent-to-treat (ITT) population, treatment with LYR-210 resulted in a mean (SD) improvement in the 3CS score of 2.35 (2.28) points, compared to 1.89 (2.07) points in sham control.

在意向治疗（ITT）人群中，LYR-210治疗导致3CS评分平均（SD）改善2.35（2.28）分，而假对照组为1.89（2.07）分。

In the ITT population, treatment with LYR-210 resulted in a mean (SD) improvement in the Sino-Nasal Outcome Test (SNOT-22) score of 20.2 (21.38) points, compared to 15.70 (18.55) points in sham control.

在ITT人群中，LYR-210治疗导致鼻窦结局测试（SNOT-22）评分的平均（SD）改善20.2（21.38）分，而假对照组为15.70（18.55）分。

Ethmoid sinus opacification (evaluated by computed tomography (CT) scans), did not achieve statistically significant improvement after treatment with LYR-210 compared to sham control.

与假对照组相比，用LYR-210治疗后筛窦混浊（通过计算机断层扫描（CT）扫描评估）未取得统计学显着改善。

LYR-210 was generally well tolerated, with no product-related serious adverse events. The most commonly reported adverse events in the study population were epistaxis, nasal odor, upper respiratory tract infection and sinusitis.

LYR-210通常耐受性良好，没有与产品相关的严重不良事件。研究人群中最常报告的不良事件是鼻出血，鼻味，上呼吸道感染和鼻窦炎。

The ENLIGHTEN 1 trial is ongoing and data from the 52-week extension phase are expected in Q4 2024. ENLIGHTEN 2, the second pivotal Phase 3 trial of LYR-210 in CRS, is ongoing.

启蒙1号试验正在进行中，52周延期阶段的数据预计将于2024年第四季度发布。启蒙2是CRS中LYR-210的第二个关键的3期临床试验，正在进行中。

The Company expects to make near-term changes to its business operations and to reduce its workforce in order to preserve cash.

该公司预计将在短期内对其业务运营进行调整，并减少劳动力，以保存现金。

About the ENLIGHTEN 1 Trial

关于启蒙1号审判

ENLIGHTEN 1 is a randomized, blinded, sham-controlled trial designed to evaluate the efficacy and safety of LYR-210 in patients with chronic rhinosinusitis (CRS) who have failed medical management and have not had prior ethmoid sinus surgery, randomized 2:1 to either LYR-210 or sham control for 24 weeks.

启蒙1是一项随机，盲法，假对照试验，旨在评估LYR-210对慢性鼻-鼻窦炎（CRS）患者的疗效和安全性，这些患者的医疗管理失败，并且之前没有进行过筛窦手术，随机2:1至LYR-210或假对照24周。

At the end of the treatment phase, patients in the control group receive crossover LYR-210 treatment while patients in the LYR-210 group are re-randomized 1:1 to either receive a crossover sham-procedure or a repeat treatment with LYR-210 (7500 µg mometasone furoate); all patients are then followed through 52 weeks..

在治疗阶段结束时，对照组患者接受交叉LYR-210治疗，而LYR-210组患者以1:1重新随机分组，接受交叉假手术或LYR-210重复治疗（7500μg糠酸莫米松）；然后对所有患者进行52周的随访。。

ENLIGHTEN 1 enrolled a total of 190 patients, approximately two-thirds from U.S. sites and one-third from sites in Europe. The mean baseline 3CS scores were 6.9 points and 6.7 points for treatment and sham control arms, respectively, and the mean SNOT-22 scores were 61 points in both the treatment and sham control arms.

启蒙1共招募了190名患者，其中约三分之二来自美国，三分之一来自欧洲。治疗组和假对照组的平均基线3CS评分分别为6.9分和6.7分，治疗组和假对照组的平均SNOT-22评分均为61分。

The baseline CT opacification scores were 44.9% and 47.3% for the treatment and sham control arms, respectively..

治疗组和假对照组的基线CT混浊评分分别为44.9%和47.3%。。

About LYR-210

关于LYR-210

LYR-210 is an investigational product candidate for the treatment of chronic rhinosinusitis (CRS) for up to four million CRS patients in the U.S. who fail current therapies annually and require further intervention. LYR-210 is a bioabsorbable sinonasal implant that is designed to deliver six months of continuous anti-inflammatory medication (7500µg mometasone furoate) to the sinonasal passages for the treatment of CRS.

LYR-210是美国多达400万慢性鼻-鼻窦炎（CRS）患者治疗慢性鼻-鼻窦炎（CRS）的候选研究产品，这些患者每年都会失败，需要进一步干预。LYR-210是一种生物可吸收的鼻腔植入物，旨在向鼻腔通道输送六个月的连续抗炎药物（7500µg糠酸莫米松），用于治疗CRS。

CRS is a highly prevalent inflammatory disease of the paranasal sinuses which leads to debilitating symptoms and significant morbidities and is the fifth most common condition in people under age 65..

CRS是一种高度流行的副鼻窦炎症性疾病，可导致衰弱症状和严重疾病，是65岁以下人群中第五大常见疾病。。

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 has two product candidates, LYR-210 and LYR-220, in late-stage development for CRS, a highly prevalent inflammatory disease of the paranasal sinuses which leads to debilitating symptoms and significant morbidities.

Lyra Therapeutics，Inc.是一家临床阶段生物技术公司，开发用于治疗慢性鼻-鼻窦炎（CRS）的长效抗炎鼻腔植入物。Lyra Therapeutics在CRS的晚期开发中有两种候选产品LYR-210和LYR-220，CRS是一种高度流行的鼻窦炎症性疾病，可导致虚弱症状和严重疾病。

LYR-210 and LYR-220 are bioabsorbable nasal implants designed to be administered in a simple, in-office procedure and are 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和LYR-220是生物可吸收的鼻腔植入物，旨在以简单的办公室程序给药，旨在向鼻窦通道提供六个月的连续抗炎药物治疗（7500µg糠酸莫米松），用于单次给药治疗CRS。

LYR-210, being evaluated in the ENLIGHTEN Phase 3 clinical program, has a smaller dimension and is intended for patients with standard anatomy, primarily patients who have not undergone ethmoid sinus surgery. LYR-220 is a larger implant designed for CRS patients whose nasal cavity is enlarged due to previous ethmoid sinus surgery.

LYR-210正在接受启蒙3期临床计划的评估，其尺寸较小，适用于具有标准解剖结构的患者，主要是未接受筛窦手术的患者。LYR-220是一种较大的植入物，专为因先前的筛窦手术而鼻腔扩大的CRS患者设计。

These two product candidates are designed 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..

这两种候选产品旨在治疗美国每年约400万未能通过医疗管理的CRS患者。有关更多信息，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,” “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》所指的前瞻性声明。“相信”、“可能”、“会”、“估计”、“继续”、“预期”、“打算”、“预期”等词语以及类似的表达都是为了识别前瞻性陈述。

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 1 topline results, which will inform our path forward including our ongoing ENLIGHTEN 2 study, the timing of the full 52-week data for the ENLIGHTEN 1 study, the timing of, and the results of, the ongoing ENLIGHTEN 2 trial, the timing and scope of our near-term changes to our business operations and reduction in force in order to preserve cash, and the safety and efficacy of our product candidates.

本新闻稿中包含的所有与历史事实无关的声明都应被视为前瞻性声明，包括关于我们对启蒙1 topline结果的评估和调查的声明，这些声明将为我们的前进道路提供信息，包括我们正在进行的启蒙2研究，启蒙1研究的完整52周数据的时间安排，正在进行的启蒙2试验的时间安排和结果，我们近期改变业务运营的时间和范围，以及为了保存现金而减少武力，以及我们候选产品的安全性和有效性。

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 fact that the Company has incurred significant losses since inception and expects to incur additional losses for the foreseeable future; the Company's need for additional funding, which may not be available; the Company’s ability to continue as a going concern; the Company’s limited operating history; the fact that the Company has no approved products; the fact that the Company’s product candidates are in various stages of development; the fact that clinical trial data is s.

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、不确定性和其他重要因素，这些因素可能导致公司的实际业绩、业绩或成就与前瞻性声明明示或暗示的任何未来业绩、业绩或成就有重大差异，包括但不限于以下内容：公司自成立以来已遭受重大损失，预计在可预见的未来会遭受额外损失；公司需要额外资金，但可能无法获得；公司持续经营的能力；公司有限的经营历史；公司没有批准的产品；公司的候选产品处于不同的开发阶段；临床试验数据是s。

Ellen Cavaleri, Investor Relations

Ellen Cavaleri，投资者关系

615.618.6228

615.618.6228

ecavaleri@lyratx.com

ecavaleri@lyratx.com