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
- 公司的知識產權現在包括PrimeC的組合、配方和使用方法
- 專利保護延長至2042年，爲PrimeC的知識產權保護又增加了四年
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.
馬薩諸塞州劍橋，2024年9月24日 / PRNewswire / - 神經感知療法有限公司（納斯達克：NRSN）（「神經感知」），一家處於晚期臨床階段的生物技術公司，正在開發用於治療嚴重神經退行性疾病的新型治療方法，今天宣佈美國專利與商標局（USPTO）頒發了一項關鍵專利。新頒發的專利，題爲「含環丙沙星和塞來昔布的組合物」（美國專利號US 12,097,185），涉及PrimeC的新配方，神經感知治療公司用於治療肌萎縮性側索硬化症（ALS）的主要藥物候選者。預計此專利將使PrimeC的專利保護延長四年，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由環丙沙星和塞來昔布組成，這是兩種FDA批准的化合物，以獨特劑量配製，並採用緩釋技術來同步它們的藥代動力學（PK）曲線，並增強它們的治療協同作用。這種創新方法旨在優化治療的有效性，減緩ALS的進展。
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.
專利授予是在神經感知最近的臨床研究結果之後，PrimeC表現出36%的疾病進展減少（p = 0.009）和43%的生存率改善，與安慰劑相比，突顯了它作爲ALS突破性療法的潛力。
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."
神經感知首席執行官Alon Ben-Noon評論說：「PrimeC不僅僅是兩種FDA批准的化合物的組合-它是一種創新配方，同步它們的藥代動力學以釋放它們的完整治療潛力。環丙沙星和塞來昔布之間的協同作用旨在最大程度地提高有效性，將ALS治療的可能性推向極限。」
About ALS
關於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.
肌萎縮性側索硬化（「ALS」）是一種不可治癒的神經退行性疾病，會導致完全癱瘓，並在診斷後2-5年內死亡。每年，僅在美國就有5000多人被診斷患有ALS，年度疾病負擔達10億美元。到2040年，在美國和歐盟，患有ALS的人數預計將增長24%。
About ALSFRS-R
關於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.
疾病進展是通過美國食品和藥物管理局（FDA）認可的最常用的ALS追蹤工具ALS功能評級量表-修訂版（ALSFRS-R）來衡量的，被治療ALS患者的神經學家在臨床試驗中以及其他監管機構用於判斷疾病進展。它隨着時間跟蹤人的12種身體能力變化，包括：言語、行走、爬樓梯、穿衣/衛生、筆跡、翻身、切食物、流涎、吞嚥和呼吸。ALSFRS-R上的單個點變化對ALS患者有重大影響，例如從獨立進食轉爲需要幫助或從獨立呼吸轉爲需要使用呼吸機。
About PARADIGM
關於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是一項前瞻性、跨國、隨機、雙盲、安慰劑對照的第20期（NCT05357950）臨床試驗，旨在研究PrimeC對ALS的療效。該試驗包括加拿大、意大利和以色列68名患有ALS的參與者。完成6個月雙盲試驗部分的試驗參與者中，96%選擇通過開放標籤延長12個月接受PrimeC治療。截至目前（2024年6月），所有完成18個月試驗治療持續時間的參與者均要求繼續接受PrimeC治療，該治療由研究者發起的試驗提供，時間不受限制。
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.
如此前報道，在試驗的6個月雙盲段中，數據顯示在意圖治療（ITT）人群分析中，PrimeC相較安慰劑有29%的臨床意義上有效的差異。從PARADIGm的PP上線分析中觀察到在ALSFRS-R方面有37.4%的（p=0.03）PrimeC相較安慰劑有顯著減緩疾病進展的差異。在試驗的積極和安慰劑兩組中，大多數患者同時接受了Riluzole，這是ALS標準治療藥物，表明PrimeC顯著減緩了疾病進展，遠遠超過了FDA批准的ALS藥物。
About PrimeC
關於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的首席藥物候選PrimeC是一種新型的延長釋放口服制劑，由兩種FDA批准的藥物：環丙沙星和塞來昔布的獨特固定劑量組合構成。PrimeC旨在協同作用地靶向多種導致運動神經元退化的ALS關鍵機制，包括炎症、鐵積累和受損的核糖核酸（"RNA"）調節，從而潛在地抑制ALS的進展。NeuroSense完成了一項2a期臨床試驗，達到了其安全性和有效性終點，包括減少功能和呼吸惡化以及統計學上顯著的ALS相關生物標誌物變化，表明PrimeC的生物活性。PrimeC已被美國食品和藥物管理局以及歐洲藥品管理局授予孤兒藥品認定。
About NeuroSense
關於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.是一家臨床階段的生物技術公司，致力於發現和開發治療患有神經退行性疾病的患者的藥物。NeuroSense認爲，這些疾病，包括肌萎縮性脊髓側索硬化症（ALS）、阿爾茨海默病和帕金森病等，代表了我們這個時代最重要的醫學需求之一，迄今爲止，患者的有效治療選擇有限。由於神經退行性疾病的複雜性和基於大量相關生物標誌物的強有力的科學研究，NeuroSense的策略是開發結合療法，靶向與這些疾病相關的多個路徑。
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，歡迎訪問我們的網站並關注我們的LinkedIn、YouTube和X。任何可能對投資者有重要意義的信息都可能定期發佈在我們的網站和這些社交媒體渠道上。
Forward-Looking Statements
前瞻性聲明
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.
本新聞發佈包含"前瞻性陳述"，這些陳述受到重大風險和不確定性的影響。本新聞發佈中包含的所有陳述，除歷史事實陳述外，均爲前瞻性陳述。本新聞稿中的前瞻性陳述可以通過使用諸如"期望"，"相信"，"考慮"，"可能"，"估計"，"預計"，"打算"，"謀求"，"可能"，"或許"，"計劃"，"潛在"，"預測"，"項目"，"目標"，"旨在"，"應該"，"將會"，"將"等詞彙識別，或這些詞彙的否定形式或其他類似表達方式，儘管並非所有前瞻性陳述都包含這些詞彙。前瞻性陳述基於NeuroSense Therapeutics目前的預期，受困難預測的固有不確定性、風險和假設的影響，幷包括關於PrimeC作爲治療ALS患者潛在性的陳述。此外，某些前瞻性陳述基於未來事件的假設，這些假設可能不準確。未來事件和趨勢可能不會發生，實際結果可能大幅且不利地與前瞻性陳述中預期或暗示的結果有所不同。這些風險包括意外的研發費用或營業費用、PARADIGm臨床試驗額外結果的報告延遲、期望的監管和業務里程碑的時間安排、與FDA會面以確定根據PARADIGm臨床試驗結果制定最佳路線的風險，包括此類會面的任何延遲；PrimeC安全有效地靶向ALS的潛力；PrimeC的臨床前和臨床數據；關於現有和未來臨床試驗結果和時間安排的不確定性；報告數據的時間；Neurosense任何產品候選藥物的開發和商業潛力；NeuroSense繼續在納斯達克上市的能力；以及NeuroSense在美國證券交易委員會（SEC）提交的文件中列明的其他風險和不確定性。您不應將這些陳述視爲我們未來觀點的代表。關於影響NeuroSense的風險和不確定性的更多信息，詳見2024年4月4日提交給美國證券交易委員會的20-F表格的"風險因素"標題以及NeuroSense隨後向SEC提交的文件。本公告中的前瞻性陳述截至公告日期發佈，NeuroSense無需更新此類信息，除非適用法律要求。
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