MIRA Pharmaceuticals Submits IND for Ketamir-2 to FDA, Marking a Significant Milestone in the Company's Pipeline Development
MIRA Pharmaceuticals Submits IND for Ketamir-2 to FDA, Marking a Significant Milestone in the Company's Pipeline Development
MIAMI, FL / ACCESSWIRE / December 19, 2024 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA), a preclinical-stage pharmaceutical company focused on developing therapies for neurological and neuropsychiatric disorders, today announced that it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for Ketamir-2, its novel oral ketamine analog for the treatment of neuropathic pain. The IND submission marks a major step in advancing Mira's lead drug candidate while reflecting its commitment to meeting milestones and timelines.
邁阿密,佛羅里達州 / ACCESSWIRE / 2024年12月19日 / MIRA藥品公司(納斯達克:MIRA),是一家專注於開發神經和神經精神疾病治療方案的臨床前階段藥品公司,今天宣佈提交了一份針對其新型口服氟氯胺酮類藥物Ketamir-2的研究新藥(IND)申請,旨在治療神經性疼痛。該IND提交標誌着Mira的首要藥物候選項目的重大進展,同時也反映了其實現里程碑和時間表的承諾。
Erez Aminov, Chairman & CEO of Mira, stated: "This IND submission highlights our team's commitment to executing efficiently as we advance transformative therapies. Ketamir-2 not only has demonstrated remarkable potential for neuropathic pain but also offers a broad opportunity across other major neuropsychiatric conditions. We look forward to beginning Phase I trials and continuing to deliver on our mission to address unmet medical needs."
Mira的董事長兼首席執行官Erez Aminov表示:"這份IND提交突出展示了我們團隊在推進變革性療法方面高效執行的承諾。Ketamir-2不僅展現了對神經性疼痛的顯著潛力,還在其他主要神經精神疾病方面提供了廣泛的機會。我們期待着開始I期臨床試驗,並繼續兌現解決未滿足醫療需求的使命。"
The IND application includes comprehensive data and reports detailing Ketamir-2's pharmacology, pharmacokinetics, and toxicology, along with results from both in vitro and in vivo studies, including validated neuropathic pain disease models. In parallel with the submission, the company is preparing to conduct a complementary neurotoxicity study, as required by the FDA's written feedback to the pre-IND documentation.
該IND申請包括詳盡的數據和報告,詳細說明了Ketamir-2的藥理學、藥代動力學和毒理學,以及來自體外和體內研究的結果,包括經過驗證的神經性疼痛疾病模型。與提交報告同時,公司正在準備進行一項補充神經毒性研究,作爲FDA對預IND文件書面反饋的要求。
According to a market analysis report from Fortune Business Insights, the neuropathic pain market in North America, including the United States, Canada, and Mexico, is valued at $3.1 billion and is expected to grow at a 6-7% compound annual growth rate (CAGR), reaching $4.5 billion by 2030. Despite this growth, existing treatments remain inadequate. Gabapentin and pregabalin, while widely prescribed, provide limited efficacy and are associated with side effects such as sedation, dizziness, and weight gain. Opioids remain a common treatment option but come with well-known risks of dependency, addiction, and respiratory depression. Intravenous ketamine, though effective for some patients, requires invasive administration and is often associated with psychotropic side effects, including hallucinations and dissociation.
根據Fortune Business Insights的市場分析報告,北美(包括美國、加拿大和墨西哥)的神經性疼痛市場價值爲31億美元,預計以每年6-7%的複合年增長率(CAGR)增長,到2030年達到45億美元。儘管增長迅速,現有治療方案仍然不夠有效。加巴噴丁和普瑞巴林雖然被廣泛開處方,但有效性有限,並且與嗜眠、頭暈和體重增加等副作用相關。阿片類藥物仍然是常見的治療選項,但伴隨着衆所周知的依賴、成癮和呼吸抑制風險。靜脈注射氟氯胺酮對某些患者有效,但需要侵入性給藥,且通常與精神藥性副作用相關,包括幻覺和離解。
Ketamir-2 is specifically designed to address the limitations of existing treatments through its selective targeting of the NMDA receptor. By binding to a specific site on the NMDA receptor with low affinity, Ketamir-2 significantly reduces the risk of psychotropic effects commonly associated with traditional ketamine. Furthermore, it is not a substrate for P-glycoprotein (P-gp), which allows for better oral absorption and enhanced blood-brain barrier penetration. Unlike traditional ketamine, Ketamir-2 does not cause sedation or hyperactivity-side effects often linked to psychiatric conditions such as schizophrenia, bipolar mania, and ADHD. As a non-opioid therapy, Ketamir-2 is designed to eliminate the risks of dependency and addiction. Additionally, the DEA has determined that Ketamir-2 is not a controlled substance, streamlining accessibility and minimizing regulatory hurdles.
Ketamir-2專門設計用於解決現有治療的侷限性,通過選擇性靶向NMDA受體。Ketamir-2以低親和力結合NMDA受體的特定部位,從而顯著降低了傳統氯胺酮常見的精神藥物效應的風險。此外,它不是P-糖蛋白(P-gp)的底物,因此可以更好地被口服吸收並增強血腦屏障的穿透能力。與傳統氯胺酮不同,Ketamir-2不會引起與精神疾病如精神分裂症、躁鬱症和注意力缺陷多動症(ADHD)相關的鎮靜或亢奮等副作用。作爲一種非阿片類療法,Ketamir-2旨在消除依賴性和成癮的風險。此外,DEA已確定Ketamir-2不是受管制物質,從而簡化了可及性並最小化了監管障礙。
Preclinical studies have demonstrated Ketamir-2's ability to achieve 100% pain reversal, fully normalizing pain thresholds in validated neuropathic pain models. Furthermore, Ketamir-2 has shown a strong safety and toxicological profile, observed across cardiovascular, CNS, respiratory, or toxicology assessments.
臨床前研究已證明Ketamir-2能夠實現100%的疼痛逆轉,在已驗證的神經性疼痛模型中完全正常化疼痛閾值。此外,Ketamir-2顯示出強大的安全和毒理特徵,在心血管、神經系統、中樞神經系統(CNS)、呼吸系統或毒理評估中均有觀察。
Dr. Itzchak Angel, Chief Scientific Advisor at Mira, commented: "Ketamir-2's selective mechanism of action, strong safety profile, and ability to achieve full pain reversal underscore its potential as a transformative therapy."
Mira的首席科學顧問Itzchak Angel博士評論道:"Ketamir-2選擇性作用機制、強大的安全特徵和實現完全疼痛逆轉的能力凸顯了其作爲變革性療法的潛力。"
With the IND submitted, MIRA expects to initiate Phase I Clinical Trials in Q1 2025 to evaluate safety, tolerability, pharmacokinetics and pharmacodynamics in healthy volunteers. Phase IIa trials are expected to follow in late 2025 to assess efficacy in neuropathic pain patients. Beyond neuropathic pain, the company is exploring additional indications for Ketamir-2, including MDD, MDD-SI, TRD and PTSD.
隨着IND的提交,MIRA預計將在2025年第一季度啓動I期臨床試驗,以評估健康志願者的安全性、耐受性、藥代動力學和藥效學。IIa期試驗預計將在2025年底隨之進行,以評估在神經性疼痛患者中的療效。除了神經性疼痛之外,該公司正在探索Ketamir-2的其他適應症,包括重度抑鬱症(MDD)、有自殺意念的重度抑鬱症(MDD-SI)、耐藥性抑鬱症(TRD)和創傷後應激障礙(PTSD)。
About MIRA Pharmaceuticals, Inc.
關於MIRA製藥公司,Inc.
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製藥公司(納斯達克:MIRA)是一家臨床前階段藥品開發公司,擁有兩個針對廣泛神經病學和神經精神疾病的神經科學項目。MIRA擁有Ketamir-2的美國、加拿大和墨西哥的獨家權利,Ketamir-2是一種新型的、待申請專利的口服氯胺酮類似物,正在研究用於治療神經性疼痛(NP)、耐藥性抑鬱症(TRD)、有自殺意念的重度抑鬱症(MDD-SI)和創傷後應激障礙(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的新型口服藥品大麻類似物MIRA-55目前正在研究用於治療患有焦慮和認知能力下降的成年患者,這種情況通常與早期階段的癡呆有關。如果得到FDA的批准,MIRA-55可能標誌着在應對各種神經精神、炎症和神經系統疾病及障礙方面的重要進展。
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.
美國藥物管制局的科學評審得出結論,Ketamir-2和MIRA-55都不會被視爲受控物質或在《受控物質法》及其管理法規下列出的化學品。
Additional information about MIRA Pharmaceuticals is available at .
有關MIRA藥品的更多信息可在此處獲得。
Cautionary Note Regarding Forward-Looking Statements
關於前瞻性聲明的警示說明
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.
本新聞稿以及MIRA藥品(或「公司」)管理層相關的陳述包含「前瞻性陳述」,這些陳述是根據《1933年證券法》第27A條修訂版和《1934年證券交易法》第21E條修訂版的安全港條款作出的,而非歷史事實。這些陳述可以通過「旨在」、「預期」、「相信」、「可能」、「估計」、「期望」、「預測」、「目標」、「意圖」、「也許」、「計劃」、「可能的」、「潛在的」、「尋求」、「將」及其變體或旨在識別前瞻性陳述的類似表述來識別。本新聞稿中任何不是歷史事實的陳述都可能被視爲前瞻性。這些前瞻性陳述包括但不限於,關於預計的研究結果好處的陳述以及公司其他前臨床研究的時間安排和Ketamir-2的IND申請的陳述。本新聞稿中的任何前瞻性陳述僅基於公司截至本發佈日的當前期望、估計和預測,並面臨許多風險和不確定性(其中許多超出了公司的控制),這些因素可能導致實際結果與這些前瞻性陳述中所述或暗示的結果有重大和不利的差異。這些以及有關公司項目和運營的其他風險在截至2023年12月31日的10-K年度報告及其他SEC文件中有更詳盡的描述,這些文件已向SEC提交,並在公司網站上列出。公司明確不承擔更新任何前瞻性陳述的義務,除非法律要求。
Contact Information
聯繫信息
Helga Moya
info@mirapharma.com
(786) 432-9792
赫爾加·莫雅
info@mirapharma.com
(786) 432-9792
SOURCE: Mira Pharmaceuticals, Inc.
來源:米拉藥品公司。
譯文內容由第三人軟體翻譯。