MIRA Pharmaceuticals Announces Ketamir-2 Outperforms Current FDA-Approved Neuropathic Pain Treatments, Gabapentin and Pregabalin, in Preclinical Study
MIRA Pharmaceuticals Announces Ketamir-2 Outperforms Current FDA-Approved Neuropathic Pain Treatments, Gabapentin and Pregabalin, in Preclinical Study
MIAMI, FL / ACCESSWIRE / October 21, 2024 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA), a leading pre-clinical-stage pharmaceutical development company, is excited to announce that its novel oral ketamine analog, Ketamir-2, has shown greater pain relief compared to FDA-approved treatments Gabapentin (Neurontin) and Pregabalin (Lyrica). Ketamir-2, a non-opioid, offers tremendous promise for patients seeking better solutions for neuropathic pain without the habit-forming risks or debilitating side effects associated with existing medications.
迈阿密，佛罗里达州/ACCESSWIRE/2024年10月21日/MIRA药品公司（纳斯达克股票代码：MIRA），一家领先的处于临床前阶段的药品开发公司，很高兴宣布其新型口服氯胺酮类似物Ketamir-2相对于FDA批准的治疗Gabapentin（诺迪卡）和Pregabalin（利洛平）表现出更好的止痛效果。Ketamir-2作为一种非阿片类药物，为寻求更好神经病痛解决方案的患者提供了巨大的希望，而不会出现与现有药物相关的形成依赖风险或致残的副作用。
Key Study Findings:
主要研究发现：
The latest preclinical study, conducted using a nerve ligation-induced neuropathy model in female rats, demonstrated that low doses of oral Ketamir-2 provided significant pain relief by Day 15. By Day 22, Ketamir-2 achieved up to 112% more effective results than Pregabalin and 70% greater relief than Gabapentin at higher doses. These findings build on prior studies in male rats, where Ketamir-2 fully reversed neuropathic pain, while oral ketamine showed no effect. This consistent efficacy across different models further highlights Ketamir-2's potential to deliver superior, effective relief through the oral route, positioning it as a promising alternative to current treatments.
最新的临床前研究在雌性大鼠神经结扎诱导的神经病模型中进行，证明低剂量口服Ketamir-2在第15天提供了显著的止痛效果。到第22天，Ketamir-2在更高剂量上实现的效果比Pregabalin高出112%，比Gabapentin高出70%。这些发现基于先前在雄性大鼠中的研究，Ketamir-2完全逆转了神经病痛，而口服氯胺酮则没有效果。这种跨不同模型的一致疗效进一步突显了Ketamir-2通过口服途径提供卓越、有效缓解的潜力，使其成为当前治疗的有望替代品。
Limitations of Current FDA-Approved Treatments and the Need for Innovation:
目前FDA批准治疗的局限性及创新的需求：
Neuropathic pain is a growing global health concern, with increasing prevalence linked to conditions like diabetes, chemotherapy-induced nerve damage, and post-herpetic neuralgia. The demand for effective pain management is reflected in the large and expanding market for treatments like Gabapentin (Neurontin) and Pregabalin (Lyrica). Gabapentin is expected to reach $4.95 billion by 2033, growing at a 6.12% CAGR (source). Similarly, the pregabalin market is forecast to grow to $2.2 billion by 2032, driven by the need for chronic pain relief (source).
神经病痛是一个日益严重的全球健康问题，与糖尿病、化疗引起的神经损伤和带状疱疹后遗神经病等疾病的增多有关。对有效疼痛管理的需求反映在Gabapentin（诺迪卡）和Pregabalin（利洛平）等治疗药物的庞大和不断扩大的市场上。预计到2033年，Gabapentin的市场规模将达到49.5亿美元，以6.12%的复合年增长率增长（资料来源）。同样，预计到2032年，降神经痛市场将增长到22亿美元，受持续慢性疼痛缓解的需求推动（资料来源）。
Despite their widespread use, these drugs come with significant side effects that limit their long-term effectiveness:
尽管被广泛使用，但这些药物带来的严重副作用限制了它们的长期有效性：
Gabapentin: Long-term use can cause drowsiness, dizziness, cognitive impairment, and weight gain, along with the potential for misuse and withdrawal upon discontinuation (source).
Pregabalin: As a controlled substance, Pregabalin carries a risk of dependence. Patients frequently report weight gain, edema, and cognitive issues, and withdrawal symptoms are common when the drug is stopped (source).
Gabapentin：长期使用可能导致嗜睡、头晕、认知障碍和体重增加，以及潜在的滥用和在停药后引起戒断症状（资料来源）。
普瑞巴林：作为一种受控物质，普瑞巴林具有成瘾风险。患者经常报告体重增加、水肿和认知问题，并在停药时常见戒断症状（来源）。
Ketamir-2: A Safer, More Effective Alternative:
Ketamir-2：更安全、更有效的替代品：
Ketamir-2 offers several key advantages over current treatments:
Ketamir-2相对于当前治疗方案提供了几个关键优势：
Non-Habit Forming: Unlike Pregabalin, Ketamir-2 carries no known risk of dependence, making it safer for long-term use.
Superior Pain Relief: The preclinical data shows that Ketamir-2 offers better efficacy than Pregabalin and better efficacy than Gabapentin.
Fewer Cognitive Side Effects: With the potential to avoid sedation and cognitive impairment, Ketamir-2 offers an improved quality of life compared to currently available treatments.
不形成习惯：与普瑞巴林不同，Ketamir-2没有已知的成瘾风险，使其更安全地长期使用。
较优越的疼痛缓解：临床前数据显示，Ketamir-2的效果比普瑞巴林和加巴喷丁更好。
更少的认知副作用：有望避免嗜睡和认知损伤，Ketamir-2相比目前可用的治疗方案提供了改善的生活质量。
Expanding Ketamir-2's Potential Beyond Neuropathic Pain:
拓展Ketamir-2的潜力超越神经病痛：
MIRA is actively preparing to launch preclinical trials for post-traumatic stress disorder (PTSD), recognizing the urgent need for non-addictive treatments for PTSD. The growing mental health crisis highlights the need for effective alternatives to existing PTSD medications, and Ketamir-2 has the potential to fill that gap.
MIRA正在积极准备启动针对创伤后应激障碍（PTSD）的临床前试验，认识到创伤后应激障碍需要非成瘾治疗的紧迫需求。不断增长的心理健康危机凸显了对现有PTSD药物的有效替代品的需求，而Ketamir-2有填补这一空白的潜力。
The company is also actively pursuing government grants for PTSD and other indications, capitalizing on the increased public focus and funding initiatives aimed at mental health treatment. These grants could help accelerate the development and delivery of Ketamir-2 to patients suffering from PTSD, depression, and other neuropsychiatric conditions.
该公司也积极寻求用于创伤后应激障碍(PTSD)和其他适应症的政府资助，利用公众对心理健康治疗的增加关注和资金倡议。这些资助有助于加快Ketamir-2的研发和交付进度，以帮助患有创伤后应激障碍、抑郁症和其他神经精神疾病的患者。
Next Steps:
下一步：
MIRA is on track to submit an Investigational New Drug (IND) application for Ketamir-2 by the end of this year and is currently preparing for Phase 1 clinical trials scheduled to begin in the first quarter of 2025. The company aims to start Phase 2 trials in the last quarter of 2025, allowing for the first signs of human efficacy by the end of that year.
MIRA正计划于年底前提交Ketamir-2的新药申请(IND申请)，目前正在准备于2025年第一季度开始的1期临床试验。该公司计划于2025年最后一个季度开始2期临床试验，从而在该年底之前展示出首次人体有效性迹象。
As part of these preparations, MIRA is pursuing scientific publications to share progress and insights with the broader medical community. Ongoing preclinical studies are evaluating Ketamir-2's impact on chemotherapy-induced neuropathy, a condition that, if proven effective, could qualify the drug for FDA breakthrough designation, potentially shortening the regulatory timeline. The company is also conducting further studies for diabetic neuropathy, expanding the therapeutic potential of Ketamir-2.
作为这些准备工作的一部分，MIRA正在追求科学出版物，与更广泛的医学界分享进展和见解。正在进行的临床前研究正在评估Ketamir-2对化疗诱导神经病理的影响，如果证明有效，这可能使该药获得FDA突破性认定，潜在地缩短监管时间表。该公司还正在进一步研究糖尿病性神经病理，拓展Ketamir-2的治疗潜力。
"We are fully committed to bringing this breakthrough drug to patients as quickly as possible while backing everything we do with strong science," said Erez Aminov, Chairman and CEO of MIRA Pharmaceuticals. "Ketamir-2 has the potential not only to address neuropathic pain but also to make a significant impact in the treatment of PTSD and depression. Our goal is to ensure that those who need it most have access to this innovative treatment as soon as possible."
“我们完全致力于尽快将这一突破性药物带给患者，并将我们所做的一切都以强有力的科学支持，” MIRA Pharmaceuticals主席兼首席执行官Erez Aminov表示，“Ketamir-2不仅有望缓解神经病性疼痛，还有望在创伤后应激障碍和抑郁症治疗方面产生显著影响。我们的目标是确保最需要此创新治疗的人尽快获得使用权。”
"The very encouraging preclinical results obtained to date are truly remarkable, and we are excited about the strong promise of Ketamir-2 as we smoothly advance it through development," added Dr. Angel, Chief Scientific Advisor at MIRA Pharmaceuticals.
“迄今为止取得的非常令人鼓舞的临床前结果实在可观，我们对顺利推进Ketamir-2的研发工作感到兴奋，” MIRA Pharmaceuticals首席科学顾问Angel博士补充道。
About MIRA Pharmaceuticals, Inc
关于MIRA制药股份有限公司
MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA) is a pre-clinical-stage pharmaceutical development company with two neuroscience programs targeting a broad range of neurologic and neuropsychiatric disorders. MIRA holds the exclusive U.S., Canadian, and Mexican rights for Ketamir-2, a novel, patent-pending oral ketamine analog under investigation to treat neuropathic pain (NP), treatment-resistant depression (TRD), major depressive disorder with suicidal ideation (MDD-SI), and post-traumatic stress disorder (PTSD).
MIRA制药公司(NASDAQ:MIRA)是一家处于临床前阶段的药品开发公司，拥有两个针对广泛神经逻辑和神经精神疾病的神经科学项目。MIRA拥有Ketamir-2的独家美国、加拿大和墨西哥权利，这是一种新颖的专利待批准的口服氯胺酮类似物，用于治疗神经病性疼痛(NP)、治疗抵抗性抑郁症(TRD)、伴有自杀倾向的重度抑郁症(MDD-SI)和创伤后应激障碍(PTSD)。
MIRA's novel oral pharmaceutical marijuana analog, MIRA-55, is currently under investigation for treating adult patients suffering from anxiety and cognitive decline, often associated with early-stage dementia. If approved by the FDA, MIRA-55 could mark a significant advancement in addressing various neuropsychiatric, inflammatory, and neurologic diseases and disorders.
MIRA的新型口服药用大麻类似物MIRA-55目前正在接受调查，用于治疗患有焦虑和认知下降的成年患者，这些通常与早期痴呆症相关。如果获得FDA批准，MIRA-55可能标志着在应对各种神经精神疾病、炎症和神经病的显著进步。
The U.S. Drug Enforcement Administration's scientific review concluded that both Ketamir-2 and MIRA-55 would not be considered controlled substances or listed chemicals under the Controlled Substances Act and its governing regulations.
美国药物执法局的科学评估得出结论，Ketamir-2和MIRA-55都不会被视为受控物质或列入受控物质法案及其管理条例。
Additional information about MIRA Pharmaceuticals is available at .
有关MIRA药品的更多信息，请访问。
Cautionary Note Regarding Forward-Looking Statements
关于前瞻性声明的谨慎说明
This press release and the statements of MIRA Pharmaceuticals' (or the "Company") management related thereto contain "forward-looking statements," which are statements other than historical facts made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements may be identified by words such as "aims," "anticipates," "believes," "could," "estimates," "expects," "forecasts," "goal," "intends," "may," "plans," "possible," "potential," "seeks," "will," and variations of these words or similar expressions that are intended to identify forward-looking statements. Any statements in this press release that are not historical facts may be deemed forward-looking. These forward-looking statements include, without limitation, statements regarding the anticipated benefits of the study results described herein as well as the timing for the Company's other preclinical studies and the filing of an IND for Ketamir-2. Any forward-looking statements in this press release are based on the Company's current expectations, estimates, and projections only as of the date of this release and are subject to a number of risks and uncertainties (many of which are beyond the Company's control) that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These and other risks concerning the Company's programs and operations are described in additional detail in the Annual Report on Form 10-K for the year ended December 31, 2023, and other SEC filings, which are on file with the SEC at www.sec.gov and the Company's website at . The Company explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law.
本新闻稿及MIRA药品（或"公司"）管理层相关的声明包含"前瞻性声明"，这些声明是根据1933年修订版第27a条和1934年修订版第21e条证券法的安全港规定之外的历史事实之外的声明。这些声明可以通过"目标"，"预期"，"相信"，"可能"，"估计"，"期望"，"预测"，"目标"，"打算"，"可能"，"潜力"，"寻求"，"将"等词语来识别，或用意图识别前瞻性 statement。本新闻稿中不属于历史事实的任何声明可能被视为前瞻性。这些前瞻性声明包括但不限于，关于此处描述的研究结果预期好处以及公司其他临床前研究和Ketamir-2的IND申请提交时间。本新闻稿中的任何前瞻性声明仅基于公司截至本发布日期的当前期望、估计和预测，可能受到一系列风险和不确定性（其中许多超出公司控制范围）的影响，这些风险和不确定性可能导致实际结果与此类前瞻性声明中或其暗示不符合。有关公司项目和业务的其他风险在2023年12月31日年度10-k报告以及其他SEC提交的文件中有更详细的描述，这些文件存档于美国证券交易委员会网站www.sec.gov和公司网站。公司明确声明暂无更新前瞻性声明的义务，除非法律要求。
Contact Information
联系信息
Helga Moya
info@mirapharma.com
(786) 432-9792
Helga Moya
info@mirapharma.com
(786) 432-9792
SOURCE: Mira Pharmaceuticals, Inc.
来源：Mira Pharmaceuticals, Inc.
