MIRA Pharmaceuticals Advances Ketamir-2 Development Following Phase 1 Design Completion, Focusing on Early Clinical Efficacy Demonstration for Neuropathic Pain in 2025
MIRA Pharmaceuticals (NASDAQ:MIRA) has announced significant progress in the clinical development of its novel oral ketamine analog, Ketamir-2. The company has initiated drug product development in collaboration with Formulex, focusing on spray-dry based granulation in capsules. MIRA is on track for its Investigational New Drug (IND) filing with the FDA in December 2024. The company aims to demonstrate clinical efficacy for neuropathic pain as early as 2025 through innovative Phase I/II study designs. MIRA has finalized its Phase I clinical trial design, set to begin in early Q1 2025, assessing safety, tolerability, and pharmacokinetics in humans. The company is also exploring additional indications in mental health, including Major Depressive Disorder with Suicidal Ideation, Treatment-Resistant Depression, and Post-Traumatic Stress Disorder.
MIRA Pharmaceuticals (NASDAQ:MIRA) ha annunciato progressi significativi nello sviluppo clinico del suo nuovo analogo orale della ketamina, Ketamir-2. L'azienda ha avviato lo sviluppo del prodotto farmaceutico in collaborazione con Formulex, concentrandosi sulla granulazione a spruzzo in capsule. MIRA è sulla buona strada per la sua presentazione della richiesta di nuovo medicinale investigativo (IND) alla FDA nel dicembre 2024. L'azienda mira a dimostrare l'efficacia clinica per il dolore neuropatico già nel 2025 attraverso studi innovativi di Fase I/II. MIRA ha finalizzato il design del suo studio clinico di Fase I, che inizierà all'inizio del primo trimestre del 2025, valutando sicurezza, tollerabilità e farmacocinetica negli esseri umani. L'azienda sta anche esplorando ulteriori indicazioni nella salute mentale, inclusi il Disturbo Depressivo Maggiore con Ideazione Suicidaria, la Depression Resistente al Trattamento e il Disturbo da Stress Post-Traumatico.
MIRA Pharmaceuticals (NASDAQ:MIRA) ha anunciado avances significativos en el desarrollo clínico de su nuevo análogo oral de ketamina, Ketamir-2. La empresa ha iniciado el desarrollo del producto farmacéutico en colaboración con Formulex, enfocándose en la granulación por secado por pulverización en cápsulas. MIRA está en camino de presentar su Solicitud de Nuevo Medicamento en Investigación (IND) a la FDA en diciembre de 2024. La compañía tiene como objetivo demostrar la eficacia clínica para el dolor neuropático tan pronto como en 2025 a través de diseños de estudios innovadores de Fase I/II. MIRA ha finalizado el diseño de su ensayo clínico de Fase I, que comenzará a principios del primer trimestre de 2025, evaluando la seguridad, la tolerabilidad y la farmacocinética en humanos. La compañía también está explorando indicaciones adicionales en salud mental, incluyendo el Trastorno Depresivo Mayor con Ideación Suicida, la Depresión Resistente al Tratamiento y el Trastorno de Estrés Postraumático.
MIRA 제약(NASDAQ:MIRA)은 그들의 새로운 경구용 케타민 유사체인 Ketamir-2의 임상 개발에서 중요한 진전을 발표했습니다. 회사는 Formulex와 협력하여 스프레이 드라이 기반의 캡슐 내 구 moagem을 중점적으로 약물 제품 개발을 시작했습니다. MIRA는 2024년 12월 FDA에 생물의약품 신규 허가 신청(IND)을 제출할 예정입니다. 이 회사는 2025년까지 신경병증 통증에 대한 임상 효능을 입증할 계획이며 혁신적인 1/2상 연구 디자인을 적용할 것입니다. MIRA는 2025년 1분기 초에 시작될 1상 임상 시험 설계를 최종 확정하였으며, 인간에 대한 안전성, 내약성 및 약물동태학을 평가할 것입니다. 회사는 또한 주요 우울 장애와 자살 사고, 치료 저항성 우울증 및 외상 후 스트레스 장애를 포함한 정신 건강 분야의 추가 적응증을 탐색하고 있습니다.
MIRA Pharmaceuticals (NASDAQ:MIRA) a annoncé des avancées significatives dans le développement clinique de son nouvel analogue oral de la kétamine, Ketamir-2. L'entreprise a lancé le développement du produit médicamenteux en collaboration avec Formulex, en se concentrant sur la granulation par séchage par pulvérisation dans des capsules. MIRA est sur la bonne voie pour son dépôt de demande de médicament expérimental (IND) auprès de la FDA en décembre 2024. L'entreprise vise à démontrer l'efficacité clinique du traitement de la douleur neuropathique dès 2025 grâce à des conceptions d'études innovantes de Phase I/II. MIRA a finalisé son design d'essai clinique de Phase I, qui devrait commencer au début du premier trimestre 2025, évaluant la sécurité, la tolérance et la pharmacocinétique chez l'homme. L'entreprise explore également d'autres indications en santé mentale, notamment le trouble dépressif majeur avec idées suicidaires, la dépression résistante au traitement et le trouble de stress post-traumatique.
MIRA Pharmaceuticals (NASDAQ:MIRA) hat bedeutende Fortschritte in der klinischen Entwicklung seines neuartigen oralen Ketamin-Analogons, Ketamir-2, bekannt gegeben. Das Unternehmen hat die Entwicklung des Arzneimittelprodukts in Zusammenarbeit mit Formulex initiiert und konzentriert sich auf die Sprühtrocknung basierte Granulation in Kapseln. MIRA ist auf Kurs für die Einreichung einer investigational New Drug (IND) bei der FDA im Dezember 2024. Das Unternehmen hat zum Ziel, die klinische Wirksamkeit bei neuropathischen Schmerzen bereits 2025 durch innovative Studiendesigns der Phase I/II zu demonstrieren. MIRA hat sein Phase-I-Studien-Design abgeschlossen, das Anfang des ersten Quartals 2025 beginnen soll und Sicherheit, Verträglichkeit und Pharmakokinetik beim Menschen bewertet. Das Unternehmen untersucht auch zusätzliche Indikationen im Bereich der psychischen Gesundheit, darunter die schwere depressive Störung mit suizidalen Gedanken, therapieresistente Depression und posttraumatische Belastungsstörung.
- Initiated drug product development (capsules) of Ketamir-2 with Formulex
- On track for IND filing with FDA in December 2024
- Aiming to demonstrate clinical efficacy for neuropathic pain by 2025
- Finalized Phase I clinical trial design, set to begin in Q1 2025
- Exploring additional indications in mental health space
- None.
Insights
MIRA Pharmaceuticals' progress with Ketamir-2 is promising but still in early stages. The focus on neuropathic pain and potential for early efficacy demonstration by 2025 is ambitious. The
Key points:
- Collaboration with Formulex for drug formulation could enhance bioavailability
- IND filing scheduled for December 2024
- Preclinical studies in Diabetic and Cancer-Induced Neuropathy models
- Phase I trial design completed, set to begin Q1 2025
While the strategy seems solid, investors should note that success in preclinical stages doesn't guarantee clinical efficacy or regulatory approval.
MIRA's strategic focus on accelerating clinical development could potentially lead to faster
Investors should consider:
- Potential market size for neuropathic pain treatments
- Competitive landscape in ketamine-based therapies
- Costs associated with clinical trials and regulatory processes
- MIRA's cash runway and potential need for future financing
While the news is positive for development progress, financial implications remain uncertain without more data on the company's resources and market potential.
MIRA's approach to early efficacy demonstration is noteworthy. By prioritizing signal detection in humans by 2025, they're adopting a strategy that could accelerate development timelines and potentially reduce costs.
Key industry considerations:
- Novel oral ketamine analog could address limitations of current treatments
- Exploring multiple indications (neuropathic pain, MDD-SI, TRD, PTSD) broadens market potential
- Collaboration with academic institutions may enhance credibility and research quality
However, the competitive landscape for ketamine-based therapies is intensifying. MIRA's success will depend on demonstrating superior efficacy or safety profiles compared to existing and pipeline treatments.
MIAMI, FL / ACCESSWIRE / September 18, 2024 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA), a preclinical-stage pharmaceutical company focused on developing innovative therapies for neurologic and neuropsychiatric disorders, today announced significant progress in the clinical development planning for its novel oral ketamine analog. As part of its strategic development plan, MIRA is prioritizing the early demonstration of clinical efficacy, potentially as early as 2025, through innovative Phase I/II study designs.
Drug Product Development Initiated
MIRA has initiated drug product development (capsules) of its novel oral ketamine analog in collaboration with Formulex, a leader in nano-technology-based drug delivery and formulation. This partnership focuses on spray-dry based granulation of Ketamir-2 in capsules for clinical studies, optimizing the formulation for improved oral bioavailability and patient convenience.
IND Filing on Schedule for December 2024
The company is on track for its Investigational New Drug (IND) filing for its drug candidate Ketamir-2 with the U.S. Food and Drug Administration (FDA) in December 2024. MIRA continues to progress with all required Good Laboratory Practice (GLP) toxicological studies, with data assembly and file preparations well underway.
Prioritizing Early Efficacy Signal Detection in Humans for Neuropathic Pain by 2025
MIRA is committed to detecting an efficacy signal in humans as early as 2025. Through strategic Phase I/II study designs, the company aims to demonstrate the clinical activity in treating neuropathic pain and potentially other neurologic conditions. This approach emphasizes MIRA's dedication to accelerating the path to clinical efficacy, providing early and robust data that can drive faster decision-making and potentially expedite patient access.
MIRA is also conducting ongoing preclinical studies in animal models of Diabetic Neuropathy and Cancer-Induced Neuropathy, with efficacy results expected in late 2024. These studies are critical in refining MIRA's approach and could help identify more targeted indications within specific patient populations. "Focusing on these specific patient populations increases our chances of demonstrating meaningful clinical benefits," said Erez Aminov, Chairman and CEO of MIRA.
"Our primary goal is to demonstrate efficacy in humans as quickly as possible," added Erez Aminov. "By implementing specific study designs and leveraging our ongoing preclinical research, we aim to gather early evidence of clinical benefits, positioning our treatment as a transformative option for neuropathic pain."
Phase I Clinical Development Plan Finalized
MIRA has completed the design of its Phase I clinical trial, set to begin in early Q1 2025. This trial will assess safety, tolerability, and pharmacokinetics in humans, laying the groundwork for subsequent efficacy studies. MIRA is also collaborating with leading international academic research institutions to further refine and enhance its clinical development strategy.
"We are excited to move smoothly forward with our IND-enabling pre-clinical studies towards Phase I trials, which are designed to provide critical insights into the safety and pharmacokinetic profile of our candidate," said Dr. Itzchak Angel, Chief Scientific Advisor at MIRA. "This trial is a pivotal step in our journey to bring novel treatment options for neuropathic pain to patients, and we are committed to executing it with the highest scientific and regulatory standards."
Strengthening Regulatory and Clinical Strategy
To bolster its clinical and regulatory approach, MIRA has appointed an experienced consultant who brings extensive expertise from academia and regulatory bodies, including the FDA. This addition underscores the company's commitment to meeting the highest standards in clinical development and regulatory compliance, ensuring a smooth and efficient process.
Looking Ahead
In addition to the planned Phase I clinical trial in Q1 2025, MIRA is exploring additional indications in the mental health space, including Major Depressive Disorder with Suicidal Ideation (MDD-SI), Treatment-Resistant Depression (TRD), and Post-Traumatic Stress Disorder (PTSD). MIRA aims to broaden the therapeutic applications of its platform to address these unmet needs, with the potential to initiate a depression IND as early as next year. This initiative reflects our commitment to advancing treatments that improve patient outcomes and quality of life.
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 Pharamaceuticals, Inc.
View the original press release on accesswire.com
FAQ
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