NeuroSense Therapeutics Granted Key U.S. Patent for Novel PrimeC Formulation, Its Lead Asset for ALS and Alzheimer's
NeuroSense Therapeutics Granted Key U.S. Patent for Novel PrimeC Formulation, Its Lead Asset for ALS and Alzheimer's
- The Company's intellectual property now covers the combination, formulation, and method of use of PrimeC
- Patent protection extends through 2042, adding four additional years to PrimeC's IP umbrella
- 公司的知识产权现在包括PrimeC的组合、配方和使用方法
- 专利保护延长至2042年，为PrimeC的知识产权保护又增加了四年
CAMBRIDGE, Mass., Sept. 24, 2024 /PRNewswire/ -- NeuroSense Therapeutics Ltd. (Nasdaq: NRSN) ("NeuroSense"), a late-clinical stage biotechnology company developing novel treatments for severe neurodegenerative diseases, today announced the issuance of a pivotal patent by the United States Patent and Trademark Office (USPTO). The newly granted patent, entitled "Compositions comprising Ciprofloxacin and Celecoxib" (US Patent No. US 12,097,185), relates to the novel formulation of PrimeC, NeuroSense's leading drug candidate for the treatment of Amyotrophic Lateral Sclerosis (ALS). This patent is expected to extend PrimeC's patent protection by an additional four years, until 2042.
马萨诸塞州剑桥，2024年9月24日 / PRNewswire / - 神经感知疗法有限公司（纳斯达克：NRSN）（“神经感知”），一家处于晚期临床阶段的生物技术公司，正在开发用于治疗严重神经退行性疾病的新型治疗方法，今天宣布美国专利与商标局（USPTO）颁发了一项关键专利。新颁发的专利，题为“含环丙沙星和塞来昔布的组合物”（美国专利号US 12,097,185），涉及PrimeC的新配方，神经感知治疗公司用于治疗肌萎缩性侧索硬化症（ALS）的主要药物候选者。预计此专利将使PrimeC的专利保护延长四年，至2042年。
PrimeC is composed of ciprofloxacin and celecoxib, two FDA-approved compounds in unique doses, formulated in a technology of slow release to synchronize their pharmacokinetic (PK) profiles and enhance their therapeutic synergy. This innovative approach is designed to optimize the treatment efficacy in slowing ALS progression.
PrimeC由环丙沙星和塞来昔布组成，这是两种FDA批准的化合物，以独特剂量配制，并采用缓释技术来同步它们的药代动力学（PK）曲线，并增强它们的治疗协同作用。这种创新方法旨在优化治疗的有效性，减缓ALS的进展。
The patent grant follows NeuroSense's recent clinical findings, where PrimeC demonstrated a 36% reduction in disease progression (p=0.009) and a 43% improvement in survival rates compared to placebo, underscoring its potential as a breakthrough therapy for ALS.
专利授予是在神经感知最近的临床研究结果之后，PrimeC表现出36%的疾病进展减少（p = 0.009）和43%的生存率改善，与安慰剂相比，突显了它作为ALS突破性疗法的潜力。
Alon Ben-Noon, NeuroSense CEO commented: "PrimeC is more than a combination of two FDA-approved compounds - it's an innovative formulation that synchronizes their pharmacokinetics to unleash their full therapeutic potential. The synergy between ciprofloxacin and celecoxib is designed to maximize efficacy, pushing the boundaries of what's possible in ALS treatment."
神经感知首席执行官Alon Ben-Noon评论说：“PrimeC不仅仅是两种FDA批准的化合物的组合-它是一种创新配方，同步它们的药代动力学以释放它们的完整治疗潜力。环丙沙星和塞来昔布之间的协同作用旨在最大程度地提高有效性，将ALS治疗的可能性推向极限。”
About ALS
关于ALS
Amyotrophic lateral sclerosis ("ALS") is an incurable neurodegenerative disease that causes complete paralysis and death within 2-5 years from diagnosis. Every year, more than 5,000 people are diagnosed with ALS in the U.S. alone, with an annual disease burden of $1 billion. The number of people living with ALS is expected to grow by 24% by 2040 in the U.S. and EU.
肌萎缩性侧索硬化（“ALS”）是一种不可治愈的神经退行性疾病，会导致完全瘫痪，并在诊断后2-5年内死亡。每年，仅在美国就有5000多人被诊断患有ALS，年度疾病负担达10亿美元。到2040年，在美国和欧盟，患有ALS的人数预计将增长24%。
About ALSFRS-R
关于ALSFRS-R
Disease progression is measured by the ALS Functional Rating Scale-Revised (ALSFRS-R), which is the most widely used ALS tracking tool accepted by the FDA, utilized by neurologists treating ALS patients, in clinical trials, and by other regulators to determine disease progression. It tracks 12 changes in a person's physical abilities over time including functions such as: speech, walking, climbing stairs, dressing/hygiene, handwriting, turning in bed, cutting food, salivation, swallowing, and breathing. A single point change on the ALSFRS-R has a significant impact on ALS patients, such as the transition from independent feeding to requiring assistance or independent breathing to needing to use a machine ventilator.
疾病进展是通过美国食品和药物管理局（FDA）认可的最常用的ALS追踪工具ALS功能评级量表-修订版（ALSFRS-R）来衡量的，被治疗ALS患者的神经学家在临床试验中以及其他监管机构用于判断疾病进展。它随着时间跟踪人的12种身体能力变化，包括：言语、行走、爬楼梯、穿衣/卫生、笔迹、翻身、切食物、流涎、吞咽和呼吸。ALSFRS-R上的单个点变化对ALS患者有重大影响，例如从独立进食转为需要帮助或从独立呼吸转为需要使用呼吸机。
About PARADIGM
关于PARADIGM
PARADIGM is a prospective, multinational, randomized, double-blind, placebo-controlled Phase 2b (NCT05357950) clinical trial of PrimeC in ALS. The trial included 68 participants living with ALS in Canada, Italy, and Israel. 96% of the trial participants who completed the 6-month double-blind portion of the trial chose to receive treatment with PrimeC through a 12-month open label extension. Furthermore, to date (June 2024) all participants that completed the 18-month trial treatment duration, requested to continue PrimeC, which is provided to them in an Investigator Initiated Trial, not limited with time.
PARADIGm是一项前瞻性、跨国、随机、双盲、安慰剂对照的第20期（NCT05357950）临床试验，旨在研究PrimeC对ALS的疗效。该试验包括加拿大、意大利和以色列68名患有ALS的参与者。完成6个月双盲试验部分的试验参与者中，96%选择通过开放标签延长12个月接受PrimeC治疗。截至目前（2024年6月），所有完成18个月试验治疗持续时间的参与者均要求继续接受PrimeC治疗，该治疗由研究者发起的试验提供，时间不受限制。
As previously reported, in the 6-month double-blind segment of the trial, the data showed clinically meaningful signs of efficacy with a 29% difference in favor of PrimeC vs placebo in analysis of the intent to treat (ITT) population. In the PP top-line analysis from PARADIGM, a statistically significant slowing of disease progression was observed with a 37.4% (p=0.03) difference in ALSFRS-R in favor of PrimeC vs placebo. Most patients enrolled in both the active and placebo arms of the trial were concurrently treated with Riluzole, the ALS standard of care medication, indicating PrimeC slowed disease progression well beyond the level afforded by the FDA approved ALS drug.
如此前报道，在试验的6个月双盲段中，数据显示在意图治疗（ITT）人群分析中，PrimeC相较安慰剂有29%的临床意义上有效的差异。从PARADIGm的PP上线分析中观察到在ALSFRS-R方面有37.4%的（p=0.03）PrimeC相较安慰剂有显著减缓疾病进展的差异。在试验的积极和安慰剂两组中，大多数患者同时接受了Riluzole，这是ALS标准治疗药物，表明PrimeC显著减缓了疾病进展，远远超过了FDA批准的ALS药物。
About PrimeC
关于PrimeC
PrimeC, NeuroSense's lead drug candidate, is a novel extended-release oral formulation composed of a unique fixed-dose combination of two FDA-approved drugs: ciprofloxacin and celecoxib. PrimeC is designed to synergistically target several key mechanisms of ALS that contribute to motor neuron degeneration, inflammation, iron accumulation and impaired ribonucleic acid ("RNA") regulation to potentially inhibit the progression of ALS. NeuroSense completed a Phase 2a clinical trial which met its safety and efficacy endpoints including reducing functional and respiratory deterioration and statistically significant changes in ALS-related biological markers indicating PrimeC's biological activity. PrimeC was granted Orphan Drug Designation by the U.S. Food and Drug Administration and the European Medicines Agency.
NeuroSense的首席药物候选PrimeC是一种新型的延长释放口服制剂，由两种FDA批准的药物：环丙沙星和塞来昔布的独特固定剂量组合构成。PrimeC旨在协同作用地靶向多种导致运动神经元退化的ALS关键机制，包括炎症、铁积累和受损的核糖核酸（"RNA"）调节，从而潜在地抑制ALS的进展。NeuroSense完成了一项2a期临床试验，达到了其安全性和有效性终点，包括减少功能和呼吸恶化以及统计学上显著的ALS相关生物标志物变化，表明PrimeC的生物活性。PrimeC已被美国食品和药物管理局以及欧洲药品管理局授予孤儿药品认定。
About NeuroSense
关于NeuroSense
NeuroSense Therapeutics, Ltd. is a clinical-stage biotechnology company focused on discovering and developing treatments for patients suffering from debilitating neurodegenerative diseases. NeuroSense believes that these diseases, which include amyotrophic lateral sclerosis (ALS), Alzheimer's disease and Parkinson's disease, among others, represent one of the most significant unmet medical needs of our time, with limited effective therapeutic options available for patients to date. Due to the complexity of neurodegenerative diseases and based on strong scientific research on a large panel of related biomarkers, NeuroSense's strategy is to develop combined therapies targeting multiple pathways associated with these diseases.
NeuroSense Therapeutics, Ltd.是一家临床阶段的生物技术公司，致力于发现和开发治疗患有神经退行性疾病的患者的药物。NeuroSense认为，这些疾病，包括肌萎缩性脊髓侧索硬化症（ALS）、阿尔茨海默病和帕金森病等，代表了我们这个时代最重要的医学需求之一，迄今为止，患者的有效治疗选择有限。由于神经退行性疾病的复杂性和基于大量相关生物标志物的强有力的科学研究，NeuroSense的策略是开发结合疗法，靶向与这些疾病相关的多个路径。
For additional information, we invite you to visit our website and follow us on LinkedIn, YouTube and X. Information that may be important to investors may be routinely posted on our website and these social media channels.
如需了解更多信息，欢迎访问我们的网站并关注我们的LinkedIn、YouTube和X。任何可能对投资者有重要意义的信息都可能定期发布在我们的网站和这些社交媒体渠道上。
Forward-Looking Statements
前瞻性声明
This press release contains "forward-looking statements" that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," "aim," "should," "will" "would," or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on NeuroSense Therapeutics' current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict and include statements regarding PrimeC as a potential treatment for people with ALS. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. The future events and trends may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward looking statements. These risks include unexpected R&D costs or operating expenses, a delay in the reporting of additional results from PARADIGM clinical trial, the timing of expected regulatory and business milestones, risks associated with meeting with the FDA to determine the best path forward following the results from PARADIGM clinical trial, including a delay in any such meeting; the potential for PrimeC to safely and effectively target ALS; preclinical and clinical data for PrimeC; the uncertainty regarding outcomes and the timing of current and future clinical trials; timing for reporting data; the development and commercial potential of any product candidates of Neurosense; the ability of NeuroSense to remain listed on Nasdaq; and other risks and uncertainties set forth in NeuroSense's filings with the Securities and Exchange Commission (SEC). You should not rely on these statements as representing our views in the future. More information about the risks and uncertainties affecting NeuroSense is contained under the heading "Risk Factors" in the Annual Report on Form 20-F filed with the Securities and Exchange Commission on April 4, 2024 and NeuroSense's subsequent filings with the SEC. Forward-looking statements contained in this announcement are made as of this date, and NeuroSense undertakes no duty to update such information except as required under applicable law.
本新闻发布包含"前瞻性陈述"，这些陈述受到重大风险和不确定性的影响。本新闻发布中包含的所有陈述，除历史事实陈述外，均为前瞻性陈述。本新闻稿中的前瞻性陈述可以通过使用诸如"期望"，"相信"，"考虑"，"可能"，"估计"，"预计"，"打算"，"谋求"，"可能"，"或许"，"计划"，"潜在"，"预测"，"项目"，"目标"，"旨在"，"应该"，"将会"，"将"等词汇识别，或这些词汇的否定形式或其他类似表达方式，尽管并非所有前瞻性陈述都包含这些词汇。前瞻性陈述基于NeuroSense Therapeutics目前的预期，受困难预测的固有不确定性、风险和假设的影响，并包括关于PrimeC作为治疗ALS患者潜在性的陈述。此外，某些前瞻性陈述基于未来事件的假设，这些假设可能不准确。未来事件和趋势可能不会发生，实际结果可能大幅且不利地与前瞻性陈述中预期或暗示的结果有所不同。这些风险包括意外的研发费用或营业费用、PARADIGm临床试验额外结果的报告延迟、期望的监管和业务里程碑的时间安排、与FDA会面以确定根据PARADIGm临床试验结果制定最佳路线的风险，包括此类会面的任何延迟；PrimeC安全有效地靶向ALS的潜力；PrimeC的临床前和临床数据；关于现有和未来临床试验结果和时间安排的不确定性；报告数据的时间；Neurosense任何产品候选药物的开发和商业潜力；NeuroSense继续在纳斯达克上市的能力；以及NeuroSense在美国证券交易委员会（SEC）提交的文件中列明的其他风险和不确定性。您不应将这些陈述视为我们未来观点的代表。关于影响NeuroSense的风险和不确定性的更多信息，详见2024年4月4日提交给美国证券交易委员会的20-F表格的"风险因素"标题以及NeuroSense随后向SEC提交的文件。本公告中的前瞻性陈述截至公告日期发布，NeuroSense无需更新此类信息，除非适用法律要求。
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资料来源: NeuroSense