MIRA Pharmaceuticals' Ketamir-2 Shows 60% Greater Efficacy Than FDA-Approved Gabapentin in Reversing Chemotherapy-Induced Neuropathic Pain
MIRA Pharmaceuticals (NASDAQ:MIRA) announces that its novel oral ketamine analog Ketamir-2 shows 60% greater efficacy than FDA-approved gabapentin in treating chemotherapy-induced neuropathic pain in preclinical studies. Using the paclitaxel model, Ketamir-2 achieved near-complete pain normalization at 300 mg/kg dose. The company plans to submit an IND application by end of 2024 and begin Phase I trials in Q1 2025. MIRA is also evaluating Ketamir-2 for diabetic neuropathy, PTSD, and other conditions. The drug could potentially qualify for FDA breakthrough therapy designation, fast track, and priority review for treating rare cancer-related neuropathic pain.
MIRA Pharmaceuticals (NASDAQ:MIRA) annuncia che il suo nuovo analogo orale di ketamina Ketamir-2 mostra un'efficacia superiore del 60% rispetto al gabapentin approvato dalla FDA nel trattamento del dolore neuropatico indotto da chemioterapia in studi preclinici. Utilizzando il modello di paclitaxel, Ketamir-2 ha raggiunto una quasi completa normalizzazione del dolore con una dose di 300 mg/kg. L'azienda prevede di presentare una domanda IND entro la fine del 2024 e di avviare la fase I degli studi clinici nel primo trimestre del 2025. MIRA sta anche valutando Ketamir-2 per la neuropatia diabetica, il PTSD e altre condizioni. Il farmaco potrebbe potenzialmente qualificarsi per la designazione di terapia innovativa da parte della FDA, per la procedura accelerata e per la revisione prioritaria nel trattamento del dolore neuropatico raro legato al cancro.
MIRA Pharmaceuticals (NASDAQ:MIRA) anuncia que su nuevo análogo oral de ketamina Ketamir-2 muestra una eficacia del 60% mayor que la del gabapentín aprobado por la FDA en el tratamiento del dolor neuropático inducido por quimioterapia en estudios preclínicos. Utilizando el modelo de paclitaxel, Ketamir-2 logró una normalización casi completa del dolor a una dosis de 300 mg/kg. La compañía planea presentar una solicitud IND antes de fin de 2024 y comenzar ensayos de Fase I en el primer trimestre de 2025. MIRA también está evaluando Ketamir-2 para la neuropatía diabética, el PTSD y otras condiciones. El medicamento podría calificar potencialmente para la designación de terapia innovadora de la FDA, vía rápida y revisión prioritaria para el tratamiento del dolor neuropático raro relacionado con el cáncer.
MIRA Pharmaceuticals (NASDAQ:MIRA)는 새로운 경구용 케타민 유사체 Ketamir-2가 FDA 승인 gabapentin보다 화학요법 유도 신경병증 통증 치료에서 60% 더 높은 효능을 보여준다고 발표했습니다. 파클리탁셀 모델을 사용하여 Ketamir-2는 300 mg/kg의 용량에서 거의 완전한 통증 정복을 달성했습니다. 이 회사는 2024년 말까지 IND 신청서를 제출하고 2025년 1분기에 1상 시험을 시작할 계획입니다. MIRA는 또한 당뇨병성 신경병증, PTSD 및 기타 상태에 대해 Ketamir-2를 평가하고 있습니다. 이 약물은 드문 암 관련 신경병증 치료를 위한 FDA의 혁신 치료 지정, 신속 심사 및 우선 리뷰 자격을 받을 가능성이 있습니다.
MIRA Pharmaceuticals (NASDAQ:MIRA) annonce que son nouvel analogue oral de la kétamine, Ketamir-2, montre une efficacité supérieure de 60 % par rapport au gabapentine approuvé par la FDA dans le traitement de la douleur neuropathique induite par chimiothérapie lors d'études précliniques. En utilisant le modèle de paclitaxel, Ketamir-2 a atteint une normalisation presque complète de la douleur à une dose de 300 mg/kg. La société prévoit de soumettre une demande IND d'ici la fin de 2024 et de commencer des essais de Phase I au premier trimestre 2025. MIRA évalue également Ketamir-2 pour la neuropathie diabétique, le PTSD et d'autres conditions. Ce médicament pourrait potentiellement être éligible à la désignation de thérapie révolutionnaire de la FDA, à la procédure accélérée et à l'examen prioritaire pour le traitement de la douleur neuropathique rare liée au cancer.
MIRA Pharmaceuticals (NASDAQ:MIRA) gibt bekannt, dass sein neuartiges orales Ketamin-Analogon Ketamir-2 in präklinischen Studien eine um 60% höhere Wirksamkeit als das von der FDA genehmigte Gabapentin bei der Behandlung von chemotherapiebedingten neuropathischen Schmerzen zeigt. Im Paclitaxel-Modell erreichte Ketamir-2 bei einer Dosis von 300 mg/kg eine nahezu vollständige Normalisierung des Schmerzes. Das Unternehmen plant, bis Ende 2024 einen IND-Antrag zu stellen und im ersten Quartal 2025 mit Phase-I-Studien zu beginnen. MIRA bewertet Ketamir-2 auch für diabetische Neuropathie, PTSD und andere Erkrankungen. Das Medikament könnte potenziell für die Durchbruchtherapiedesignation der FDA, den Fast-Track und die priorisierte Überprüfung für die Behandlung von seltenen, krebsbedingten neuropathischen Schmerzen in Frage kommen.
- Ketamir-2 demonstrates 60% superior efficacy compared to FDA-approved gabapentin
- Near-complete pain normalization achieved at 300 mg/kg dose
- Multiple potential FDA fast-track pathways could accelerate market entry
- Non-opioid solution with fewer side effects than current treatments
- Planned IND submission by end-2024 with Phase I trials starting Q1 2025
- Still in pre-clinical stage with no human trial data
- Multiple clinical trials required before potential commercialization
- Dependent on future FDA approvals and designations
Insights
The preclinical data for Ketamir-2 shows remarkable promise in addressing chemotherapy-induced neuropathic pain, with 60% greater efficacy than gabapentin. The near-complete pain normalization at 300 mg/kg dosing is particularly significant, as current treatments often provide only partial relief. The potential for multiple FDA acceleration pathways - breakthrough therapy, fast track and priority review - could substantially reduce time-to-market.
The planned IND submission in Q4 2024 and parallel Phase II trials strategy demonstrates aggressive development planning. The compound's potential applications across multiple indications (chemotherapy-induced pain, diabetic neuropathy, PTSD) significantly expands its market potential. The non-opioid nature addresses critical needs in pain management while avoiding addiction risks.
For a small-cap company (
The robust preclinical data package and planned scientific publications will be important for partnership discussions and potential licensing deals. However, investors should note that significant capital will be required to fund clinical trials through 2025 and beyond, likely necessitating future financing rounds.
Promising Preclinical Results Position Ketamir-2 as a Potential Breakthrough Therapy That Surpasses Current Treatments, With Results to Be Presented at the Pain Therapeutics Summit in Boston
MIAMI, FL / ACCESSWIRE / October 28, 2024 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA), a leading pre-clinical-stage pharmaceutical development company, announces compelling new preclinical findings showing that Ketamir-2, a novel oral ketamine analog, achieves
Study Overview and Results
The study used the paclitaxel (PTX) model, where neuropathic pain was induced in mice through the administration of PTX, a common chemotherapy drug. While effective in treating cancer, PTX often causes nerve damage, leading to chemotherapy-induced neuropathy characterized by pain, numbness, and tingling. To assess Ketamir-2's efficacy, mice received PTX every other day for four doses, and pain sensitivity was measured using the Von Frey filament (VFF) test. On Day 9, at the optimal dose of 300 mg/kg, Ketamir-2 led to near-complete normalization of pain sensitivity, outperforming FDA-approved gabapentin by
The company will present these findings, along with data from previous studies, at the upcoming Pain Therapeutics Summit in Boston on October 28-29, 2024, to showcase Ketamir-2's therapeutic potential to the medical community. This presentation emphasizes MIRA's commitment to sharing its data with the broader scientific community and engaging with key opinion leaders to discuss the significance of these findings. Sharing these results with leading experts will be crucial in advancing the understanding of Ketamir-2's potential as a groundbreaking treatment.
Potential for Breakthrough Therapy, Fast track and Priority Review
The promising results from this study could pave the way for Ketamir-2 to receive FDA breakthrough therapy designation, fast track, and/or priority review as an effective treatment for rare forms of cancer-related neuropathic pain, such as that associated with Multiple Myeloma. This rare cancer affects plasma cells in the bone marrow, leading to complications like bone damage and severe nerve pain. Treatments often include chemotherapy, which can induce significant neuropathic pain and greatly impact patients' quality of life.
Managing neuropathic pain in these patients remains challenging due to the limited availability of effective treatments. By focusing on this specific patient population, Ketamir-2 could potentially qualify for multiple FDA commercialization pathways, significantly reducing the time to market and accelerating patient access to the drug.
Expanding Therapeutic Potential and Accelerating Development
Building on consistent success in neuropathic pain models, MIRA is advancing its pipeline with studies assessing Ketamir-2 for diabetic neuropathy and other conditions. The company is preparing to submit an Investigational New Drug (IND) application by the end of 2024, with plans to begin Phase I clinical trials in the first quarter of 2025. To maximize the development timeline, MIRA is considering conducting multiple Phase II trials in parallel, specifically targeting neuropathic pain across different patient populations, which could further accelerate Ketamir-2's path to market.
In addition to the ongoing studies, MIRA is in the process of submitting several scientific journal publications that detail Ketamir-2's mechanism of action, as well as the results from its pain and depression studies. These publications aim to contribute to the broader scientific understanding of Ketamir-2's therapeutic potential.
Furthermore, Ketamir-2 is under evaluation for post-traumatic stress disorder (PTSD), with preclinical studies currently underway. MIRA is actively seeking government grants to support research on PTSD and other indications, positioning Ketamir-2 as a versatile non-opioid solution for various challenging conditions
A Safer, More Effective Approach to Pain Relief
As a non-opioid, Ketamir-2 addresses the limitations associated with existing treatments like FDA-approved gabapentin and pregabalin, which often come with side effects such as cognitive impairment, weight gain, and dependency risks. Ketamir-2 offers consistent and safer pain relief without these drawbacks, making it an ideal option for long-term management.
"Ketamir-2 has demonstrated exceptional efficacy across multiple models, achieving complete pain normalization where other treatments fall short," said Erez Aminov, Chairman and CEO of MIRA. "The potential for breakthrough therapy designation further highlights its promise to transform neuropathic pain management and accelerate access for patients in need."
"The impressive results achieved to date not only validate our approach but also signal a significant leap forward in pain management," added Dr. Itzchak Angel, Chief Scientific Advisor at MIRA. "We look forward to presenting these findings and discussing Ketamir-2's potential impact at the upcoming Pain Therapeutics Summit."
About MIRA Pharmaceuticals, 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'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.
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.
Additional information about MIRA Pharmaceuticals is available at www.mirapharmaceuticals.com.
Cautionary Note Regarding Forward-Looking Statements
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 http://www.mirapharmaceuticals.com/investors/sec-filings. The Company explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law.
Contact Information:
Helga Moya
info@mirapharma.com
(786) 432-9792
SOURCE: Mira Pharmaceuticals, Inc.
View the original press release on accesswire.com
FAQ
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