MIRA Pharmaceuticals Announces Approval and Initiation of Phase 1 Clinical Trial for Ketamir-2 in Neuropathic Pain
MIRA Pharmaceuticals (NASDAQ:MIRA) has received approval to initiate Phase 1 clinical trials for Ketamir-2, their novel oral ketamine analog for neuropathic pain treatment. The trial, authorized by the Israeli Ministry of Health, will be conducted at Hadassah Medical Center in Jerusalem.
The study includes two parts: a Single Ascending Dose (SAD) with 32 participants and Multiple Ascending Dose (MAD) with 24 participants. The trial aims to evaluate safety, tolerability, and pharmacokinetics, with completion expected by Q4 2025.
Preclinical studies showed Ketamir-2's superior efficacy compared to existing treatments:
- Full pain reversal in nerve ligation models
- 60% more effective than gabapentin in chemotherapy-induced neuropathy
- Enhanced bioavailability through Pamoate salt formulation
- Improved safety profile with no cardiovascular concerns
The neuropathic pain market is projected to reach $5.2 billion in North America by 2030. The company plans to initiate Phase 2a studies in Q4 2025.
MIRA Pharmaceuticals (NASDAQ:MIRA) ha ricevuto l'approvazione per avviare studi clinici di Fase 1 per Ketamir-2, il loro nuovo analogo orale della ketamina per il trattamento del dolore neuropatico. Lo studio, autorizzato dal Ministero della Salute israeliano, sarà condotto presso il Centro Medico Hadassah a Gerusalemme.
Lo studio comprende due parti: una Dose Singola Ascendente (SAD) con 32 partecipanti e una Dose Multipla Ascendente (MAD) con 24 partecipanti. L'obiettivo della sperimentazione è valutare la sicurezza, la tollerabilità e la farmacocinetica, con completamento previsto entro il quarto trimestre del 2025.
Studi preclinici hanno dimostrato l'efficacia superiore di Ketamir-2 rispetto ai trattamenti esistenti:
- Reversibilità totale del dolore nei modelli di legatura nervosa
- Il 60% più efficace del gabapentino nella neuropatia indotta da chemioterapia
- Aumentata biodisponibilità grazie alla formulazione in sale di Pamoato
- Profilo di sicurezza migliorato senza preoccupazioni cardiovascolari
Il mercato del dolore neuropatico è previsto raggiungere 5,2 miliardi di dollari in Nord America entro il 2030. L'azienda prevede di avviare studi di Fase 2a nel quarto trimestre del 2025.
MIRA Pharmaceuticals (NASDAQ:MIRA) ha recibido la aprobación para iniciar ensayos clínicos de Fase 1 para Ketamir-2, su nuevo análogo oral de ketamina para el tratamiento del dolor neuropático. El ensayo, autorizado por el Ministerio de Salud de Israel, se llevará a cabo en el Centro Médico Hadassah en Jerusalén.
El estudio incluye dos partes: una Dosis Única Ascendente (SAD) con 32 participantes y una Dosis Múltiple Ascendente (MAD) con 24 participantes. El objetivo del ensayo es evaluar la seguridad, la tolerabilidad y la farmacocinética, con la finalización prevista para el cuarto trimestre de 2025.
Los estudios preclínicos mostraron la superior eficacia de Ketamir-2 en comparación con los tratamientos existentes:
- Reversión total del dolor en modelos de ligadura nerviosa
- 60% más efectivo que la gabapentina en la neuropatía inducida por quimioterapia
- Mayor biodisponibilidad a través de la formulación de sal de Pamoato
- Perfil de seguridad mejorado sin preocupaciones cardiovasculares
Se proyecta que el mercado del dolor neuropático alcanzará los 5.2 mil millones de dólares en América del Norte para 2030. La compañía planea iniciar estudios de Fase 2a en el cuarto trimestre de 2025.
MIRA Pharmaceuticals (NASDAQ:MIRA)는 신경병증 통증 치료를 위한 새로운 경구 케타민 유사체인 Ketamir-2의 1상 임상 시험을 시작할 수 있는 승인을 받았습니다. 이 시험은 이스라엘 보건부의 승인을 받아 예루살렘의 하다사 병원에서 진행될 예정입니다.
연구는 두 부분으로 나뉘며, 32명의 참가자를 대상으로 하는 단일 용량 상승(SAD)과 24명의 참가자를 대상으로 하는 다중 용량 상승(MAD)으로 구성됩니다. 이 시험은 안전성, 내약성 및 약리학적 동태를 평가하는 것을 목표로 하며, 2025년 4분기까지 완료될 것으로 예상됩니다.
전임상 연구에서는 Ketamir-2가 기존 치료법에 비해 우수한 효능을 보였음을 보여주었습니다:
- 신경 결찰 모델에서의 통증 완전 회복
- 화학요법 유도 신경병증에서 가바펜틴보다 60% 더 효과적
- Pamoate 염 제형을 통한 생체이용률 향상
- 심혈관 우려가 없는 개선된 안전성 프로필
신경병증 통증 시장은 2030년까지 북미에서 52억 달러에 이를 것으로 예상됩니다. 회사는 2025년 4분기에 2a상 연구를 시작할 계획입니다.
MIRA Pharmaceuticals (NASDAQ:MIRA) a reçu l'approbation pour commencer des essais cliniques de phase 1 pour Ketamir-2, leur nouvel analogique oral de la kétamine pour le traitement de la douleur neuropathique. L'essai, autorisé par le ministère israélien de la Santé, sera réalisé au Centre médical Hadassah à Jérusalem.
L'étude comprend deux parties : une dose unique ascendante (SAD) avec 32 participants et une dose multiple ascendante (MAD) avec 24 participants. L'essai vise à évaluer la sécurité, la tolérance et la pharmacocinétique, avec une achèvement prévu d'ici le quatrième trimestre 2025.
Les études précliniques ont montré l'efficacité supérieure de Ketamir-2 par rapport aux traitements existants :
- Récupération complète de la douleur dans les modèles de ligature nerveuse
- 60 % plus efficace que la gabapentine dans la neuropathie induite par la chimiothérapie
- Biodisponibilité améliorée grâce à la formulation en sel de Pamoate
- Profil de sécurité amélioré sans préoccupations cardiovasculaires
Le marché de la douleur neuropathique devrait atteindre 5,2 milliards de dollars en Amérique du Nord d'ici 2030. L'entreprise prévoit de commencer des études de phase 2a au quatrième trimestre 2025.
MIRA Pharmaceuticals (NASDAQ:MIRA) hat die Genehmigung erhalten, klinische Studien der Phase 1 für Ketamir-2, ihr neuartiges orales Ketamin-Analogon zur Behandlung von neuropathischen Schmerzen, zu beginnen. Die Studie, die vom israelischen Gesundheitsministerium genehmigt wurde, wird im Hadassah Medical Center in Jerusalem durchgeführt.
Die Studie besteht aus zwei Teilen: einer Einzel-Dosis-Steigerung (SAD) mit 32 Teilnehmern und einer Mehrfach-Dosis-Steigerung (MAD) mit 24 Teilnehmern. Ziel der Studie ist es, Sicherheit, Verträglichkeit und Pharmakokinetik zu bewerten, wobei der Abschluss bis zum 4. Quartal 2025 erwartet wird.
Präklinische Studien haben die überlegene Wirksamkeit von Ketamir-2 im Vergleich zu bestehenden Behandlungen gezeigt:
- Vollständige Schmerzlinderung in Nervenschnürrungsmodellen
- 60% effektiver als Gabapentin bei chemotherapiebedingter Neuropathie
- Erhöhte Bioverfügbarkeit durch Pamoat-Salzformulierung
- Verbessertes Sicherheitsprofil ohne kardiovaskuläre Bedenken
Der Markt für neuropathische Schmerzen wird bis 2030 in Nordamerika voraussichtlich 5,2 Milliarden USD erreichen. Das Unternehmen plant, im 4. Quartal 2025 mit Phase-2a-Studien zu beginnen.
- Phase 1 trial approval received from Israeli authorities
- Superior efficacy shown in preclinical studies vs existing treatments
- Strong safety profile with no cardiovascular concerns
- Large market opportunity: $5.2B by 2030 in North America
- Multiple potential indications including PTSD and topical pain relief
- Early-stage development (pre-clinical to Phase 1)
- Extended timeline to market with Phase 2a not starting until Q4 2025
- Competition from established treatments (gabapentin, pregabalin, opioids)
Insights
The approval and upcoming initiation of Phase 1 trials for Ketamir-2 represents a critical developmental milestone for MIRA Pharmaceuticals. This transition from preclinical to clinical stage significantly derisks their lead asset and provides a clear regulatory pathway.
The dual Single and Multiple Ascending Dose design with 56 total participants is standard for first-in-human studies, focusing on safety, tolerability, and pharmacokinetics. Conducting the trial in Israel demonstrates pragmatic resource management, potentially extending MIRA's runway while accelerating development timelines.
Preclinical data shows compelling differentiation from existing treatments. Ketamir-2 demonstrated complete pain threshold normalization in nerve ligation models where oral ketamine failed entirely. Its reported 60% superiority to gabapentin and 112% greater efficacy than pregabalin at higher doses are particularly noteworthy, as these are current standard-of-care agents with combined annual sales exceeding
Most promising is Ketamir-2's unique pharmacological profile - specifically the absence of hyperlocomotor activity (reducing psychotomimetic risks) and the extended bioavailability of its Nor-Ketamir-2 metabolite. The pamoate salt formulation appears to solve ketamine's traditional bioavailability challenges, potentially enabling practical oral administration with sustained therapeutic effects.
With the neuropathic pain market projected to reach
The advancement of Ketamir-2 into clinical trials represents a compelling approach to the persistent challenge of neuropathic pain management. The drug's mechanism targeting NMDA receptors with selective, lower-affinity binding addresses a fundamental limitation of traditional ketamine therapy – its dissociative side effects.
What distinguishes this candidate is its metabolic profile. While ketamine suffers from poor oral bioavailability and rapid clearance, Ketamir-2's primary metabolite (Nor-Ketamir-2) remains in circulation longer and appears to bypass P-glycoprotein efflux, enhancing brain penetration. The pamoate salt formulation further optimizes pharmacokinetics, potentially enabling convenient oral dosing with extended duration – critical advantages for chronic pain management.
The preclinical efficacy data is particularly striking in chemotherapy-induced neuropathy models, where Ketamir-2 outperformed established agents like gabapentin and pregabalin. This suggests potential application in cancer supportive care, an area with significant unmet needs.
The absence of hyperlocomotor activity in animal models suggests reduced risk of dissociative effects – the principal limitation of ketamine in pain management. Similarly encouraging is the reported cardiovascular and respiratory safety profile, addressing key concerns with traditional NMDA antagonists.
MIRA's parallel exploration of Ketamir-2 for PTSD leverages growing evidence of ketamine's efficacy in treatment-resistant psychiatric conditions, potentially expanding the drug's commercial applications. The planned conclusion of Phase 1 by year-end with rapid progression to Phase 2a reflects confidence in the safety profile and efficient development strategy.
MIAMI, FL / ACCESS Newswire / March 4, 2025 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA), a preclinical-stage pharmaceutical company focused on developing therapies for neurological and neuropsychiatric disorders, today announced the approval and upcoming initiation of its Phase 1 clinical trial for Ketamir-2, the Company's novel oral ketamine analog in development for neuropathic pain, with subject recruitment scheduled to begin in Q1 2025.
The study has received authorization from the Israeli Ministry of Health and the Institutional Review Board (IRB) and will be conducted at the Clinical Pharmacology Unit, Hadassah Medical Center in Jerusalem, Israel. This Phase 1, randomized, double-blind, placebo-controlled, single-center study is designed to evaluate the safety, tolerability, and pharmacokinetics of orally administered Ketamir-2 in healthy adult volunteers.
The trial consists of two parts:
Single Ascending Dose (SAD) Part: 32 participants
Multiple Ascending Dose (MAD) Part: 24 participants
In addition to assessing the frequency and severity of adverse events (AEs) and serious adverse events (SAEs), the study will closely evaluate ketamine-related behavioral side effects and assess Ketamir-2's distinct pharmacological profile.
The decision to conduct the study in Israel was made to accelerate timelines and optimize costs, allowing Mira to efficiently allocate resources and extend its operational runway. The Company expects Phase 1 to conclude by Q4 2025, paving the way for a Phase 2a study in neuropathic pain patients to be initiated by the end of the year.
Addressing a Large and Unmet Market for Neuropathic Pain
Neuropathic pain is a rapidly growing market, projected to reach
Advancing a Safe and Effective Alternative for Neuropathic Pain
MIRA's preclinical studies demonstrate Ketamir-2's superior efficacy, safety, and optimized pharmacokinetics, supporting its advancement into Phase 1 clinical trials.
Key Findings from Animal Models:
Full Neuropathic Pain Reversal:
In a nerve ligation model, Ketamir-2 fully normalized pain thresholds, while oral ketamine had no effect.
Superior to FDA-Approved Gabapentin and Pregabalin:
In a chemotherapy-induced neuropathy model (PTX), Ketamir-2 restored normal pain sensitivity, outperforming gabapentin by
60% .Up to
112% more effective than pregabalin in reducing neuropathic pain at higher doses.
No Hyperlocomotor Activity, Reducing Risk of Behavioral Side Effects:
Unlike traditional ketamine, Ketamir-2 did not induce hyperlocomotor activity, a side effect often associated with ketamine's psychotomimetic effects.
Optimized for Oral Absorption & Brain Delivery:
Not a P-glycoprotein (P-gp) substrate, allowing better absorption and brain penetration.
Selective, low affinity NMDA receptor binding reduces dissociative side effects.
Enhanced Bioavailability & Prolonged Effect with Nor-Ketamir-2:
Nor-Ketamir-2 is the primary active metabolite of Ketamir-2, formed in the body after oral administration.
Unlike traditional ketamine, which is rapidly metabolized and cleared, Nor-Ketamir-2 remains in circulation longer, leading to sustained therapeutic effects.
The Pamoate salt formulation of Ketamir-2 enhances drug absorption and bioavailability, achieving extended oral bioavailability and higher brain exposure, of nor-ketamir-2 supporting longer-lasting pain relief.
Strong Safety Profile:
No cardiovascular or respiratory concerns at high doses.
High selectivity and cleaner pharmacological profile than traditional ketamine, reducing risks of side effects.
These findings reinforce Ketamir-2's potential as a breakthrough oral treatment for neuropathic pain, offering greater efficacy, improved safety, and convenient administration over existing therapies.
"The neuropathic pain market continues to grow, yet current treatments leave millions of patients without adequate relief," said Erez Aminov, Chairman and CEO of MIRA Pharmaceuticals. "Ketamir-2 has demonstrated remarkable potential in reversing neuropathic pain while maintaining a strong safety profile. With this Phase 1 trial now set to begin, we are moving closer to bringing a much-needed oral treatment to patients suffering from chronic neuropathic pain."
Expanding Research into PTSD and Topical Pain Relief
Beyond neuropathic pain, MIRA Pharmaceuticals is conducting ongoing preclinical studies evaluating Ketamir-2 in PTSD and a potential topical formulation for localized pain relief. These additional indications could significantly broaden the clinical and commercial potential of Ketamir-2.
Dr. Angel, Chief Scientific Advisor at Mira Pharmaceuticals, added: "Ketamir-2 continues to show great promise as we are now ready for the clinical trials. Its strong safety profile and targeted mechanism of action differentiate it from traditional ketamine and other pain treatments, giving us confidence in its potential for multiple indications."
Advancing Mira-55 for Memory Enhancement
In parallel, the Company is assessing Mira-55 for its potential in memory enhancement. This program aligns with MIRA's commitment to neurological innovation, exploring treatments that could address cognitive decline and neurodegenerative conditions.
Regulatory and Development Timeline
With Phase 1 expected to conclude by year-end, Mira is on track to initiate Phase 2a studies in neuropathic pain patients in Q4 2025, further advancing the potential of Ketamir-2 as a novel treatment for neuropathic pain and other neuro indications.
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, 2024, and other SEC filings, which are on file with the SEC at www.sec.gov and the Company's website at https://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.
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