SEATTLE--(BUSINESS WIRE)--Sound Pharmaceuticals is pleased to announce that the Phase 3 clinical trial involving SPI-1005, a novel anti-inflammatory, for the treatment of Meniere’s Disease (STOPMD-3) has been completed. SPI-1005 is an oral capsule taken twice daily and the only potential therapeutic to significantly improve hearing loss and tinnitus in Meniere’s Disease patients that was documented in two completed Phase 1b and 2b studies that enrolled over 165 patients.

西雅图-（商业新闻）-桑德制药公司很高兴地宣布，涉及SPI-1005（一种新型抗炎药）治疗梅尼埃病（STOPMD-3）的3期临床试验已经完成。SPI-1005是一种口服胶囊，每天服用两次，是唯一可显着改善梅尼埃病患者听力损失和耳鸣的潜在治疗药物，已在两项已完成的1b期和2b期研究中记录，该研究招募了165多名患者。

The STOPMD-3 study enrolled eligible patients into a randomized controlled trial (RCT) for 3-months followed by an open label extension (OLE) of SPI-1005 for 6 months (OLE 6-mo) and an optional 6 additional months (OLE 12-mo). STOPMD-3 is the longest treatment trial involving an investigational new drug ever completed for a hearing loss or tinnitus indication.

STOPMD-3研究将符合条件的患者纳入随机对照试验（RCT）3个月，然后进行SPI-1005的开放标签延长（OLE）6个月（OLE 6个月）和可选的另外6个月（OLE 12个月）。STOPMD-3是迄今为止针对听力损失或耳鸣适应症完成的涉及研究新药的最长治疗试验。

RCT data unblinding and presentation of the interim topline results will occur this quarter..

RCT数据揭盲和中期topline结果的呈现将在本季度进行。。

STOPMD-3 randomization began on August 2, 2022 and the last patient last visit (OLE 12-mo) was completed on July 25, 2024. 254 patients were screened for eligibility at 11 sites including some of the leading academic centers in the US. 221 eligible patients were randomized to either SPI-1005 treatment (400 mg twice daily for 28 days) or matching placebo treatment and followed for 84 days.

STOPMD-3随机化于2022年8月2日开始，最后一次患者最后一次就诊（OLE 12 mo）于2024年7月25日完成。254名患者在包括美国一些领先学术中心在内的11个地点进行了资格筛查。221名符合条件的患者被随机分配到SPI-1005治疗（400 mg，每日两次，持续28天）或匹配的安慰剂治疗，随访84天。

201 patients continued onto SPI-1005 OLE for up to 6-mo and 12-mo. “We are grateful to all the patients that participated in this pivotal trial of SPI-1005,” said Jonathan Kil, MD, Co-Founder and CEO. SPI-1005 is the only investigational new drug that was tested in a Phase 3 trial aimed at improving hearing loss, tinnitus, and/or dizziness over the last three years..

201名患者继续使用SPI-1005 OLE长达6个月和12个月。“我们感谢所有参与SPI-1005关键试验的患者，”联合创始人兼首席执行官乔纳森·基尔医学博士说。SPI-1005是过去三年中唯一在旨在改善听力损失，耳鸣和/或头晕的3期试验中测试的研究性新药。。

STOPMD-3 was led by Dr. Paul Lambert, Distinguished University Professor and Chair Emeritus of the Dept. of Otolaryngology-HNS at MUSC in Charleston, SC, and the past President of the American Neurotologic Society. “To our knowledge, this Phase 3 study is the longest continuous treatment trial to improve hearing loss/tinnitus in patients living with Meniere’s Disease,” said Dr.

STOPMD-3由Paul Lambert博士领导，Paul Lambert博士是南卡罗来纳州查尔斯顿市马斯克大学耳鼻喉科HNS荣誉退休主席，也是美国神经病学会前任主席。“据我们所知，这项3期研究是改善梅尼埃病患者听力损失/耳鸣的最长持续治疗试验，”Dr。

Lambert. Dr. Lambert, Dr. Shaun Nguyen, and their colleagues from MUSC also led the successful Phase 2b RCT involving SPI-1005 and MD patients..

兰伯特。Lambert博士、Shaun Nguyen博士及其来自MUSC的同事也领导了成功的2b期RCT，涉及SPI-1005和MD患者。。

About Meniere’s Disease (MD)

关于梅尼埃病（MD）

MD is diagnosed by brief periods of episodic vertigo or dizziness, fluctuating low frequency hearing loss, and intermittent or constant tinnitus, and is thought to be due to a swelling of the inner ear. Patients are typically diagnosed between 40-65 years of age, and the auditory symptoms of hearing loss and tinnitus often involve only one ear.

MD的诊断是短暂的阵发性眩晕或头晕，波动性低频听力损失以及间歇性或持续性耳鸣，被认为是由于内耳肿胀引起的。患者通常被诊断为40-65岁，听力损失和耳鸣的听觉症状通常仅涉及一只耳朵。

Some patients experience aural fullness or pressure in the affected ear that can also contribute to dizziness. As patients age, the hearing loss and tinnitus become worse resulting in severe to profound hearing loss or intractable tinnitus. For the definitive diagnosis of MD, the American Academy of Otolaryngology-Head & Neck Surgery guidance requires audiometric documentation of ≥30 dB of low frequency hearing loss in at least one ear using pure tone audiometry (PTA).

一些患者在受影响的耳朵中出现听觉充盈或压力，这也可能导致头晕。随着患者年龄的增长，听力损失和耳鸣变得更加严重，导致严重至严重的听力损失或顽固性耳鸣。为了明确诊断MD，美国耳鼻咽喉头颈外科学会指南要求使用纯音测听（PTA）对至少一只耳朵进行≥30 dB低频听力损失的听力测量记录。

Loss of speech discrimination, especially in noisy environments or when tinnitus is present, is common in MD and other forms of sensorineural hearing loss. MD is currently managed with low salt diets, thiazide diuretics, and oral or locally injected steroids. Unfortunately, this standard of care has not been proven to be effective and is not FDA-approved for the treatment of definite or probable MD..

。MD目前采用低盐饮食，噻嗪类利尿剂以及口服或局部注射类固醇进行治疗。不幸的是，这种护理标准尚未被证明是有效的，也未经FDA批准用于治疗确定或可能的MD。。

About SPI-1005

关于SPI-1005

SPI-1005 is an investigational new drug that contains ebselen, a new chemical entity. Ebselen is a selenorganic compound that mimics and induces glutathione peroxidase (GPx) activity and is effective in reducing neuroinflammation across the central and peripheral nervous system. GPx activity is critical to several cell types and tissues in the inner ear, retina, prefrontal cortex of brain, lung, and kidney, and is often reduced during exposures to environmental insults or aging.

SPI-1005是一种研究性新药，含有依布硒啉（一种新的化学实体）。依布硒啉是一种模拟和诱导谷胱甘肽过氧化物酶（GPx）活性的硒有机化合物，可有效减少中枢和外周神经系统的神经炎症。GPx活性对内耳，视网膜，脑，肺和肾的前额叶皮层的几种细胞类型和组织至关重要，并且在暴露于环境污染或衰老期间通常会降低。

Loss of GPx activity has been shown to result in sensorineural hearing loss in multiple animal models. SPI-1005 is being developed for several neurotologic indications including noise-induced hearing loss and two types of ototoxicity (hearing loss, tinnitus, dizziness, or vertigo) caused by aminoglycoside antibiotics (such as tobramycin or amikacin) or platinum-based chemotherapy (such as cisplatin or carboplatin).

在多种动物模型中，GPx活性的丧失已被证明会导致感觉神经性听力损失。SPI-1005正在开发用于几种神经病理学适应症，包括噪声引起的听力损失和由氨基糖苷类抗生素（如妥布霉素或阿米卡星）或铂类化疗（如顺铂或卡铂）引起的两种耳毒性（听力损失，耳鸣，头晕或眩晕）。

To date, no significant drug-drug interactions have been observed across multiple study populations including bipolar mania and treatment resistant depression..

迄今为止，在包括躁郁症和难治性抑郁症在内的多个研究人群中，尚未观察到明显的药物相互作用。。

About Sound Pharmaceuticals

关于Sound Pharmaceuticals

A privately held biotechnology company is testing SPI-1005 under five other active Investigational New Drug Applications involving several neurotologic indications including aminoglycoside-induced ototoxicity co-funded by the CF Foundation and cochlear implant patients co-funded by MED-EL. Details of the SPI-1005 clinical trials can be viewed online at www.clinicaltrials.gov or by visiting www.soundpharma.com..

一家私营生物技术公司正在测试SPI-1005在其他五种积极的研究性新药应用中的应用，这些新药涉及几种神经病理学适应症，包括由CF基金会共同资助的氨基糖苷类药物引起的耳毒性和由MED-EL共同资助的人工耳蜗植入患者。SPI-1005临床试验的详细信息可以在www.clinicaltrials.gov或访问www.soundpharma.com在线查看。。