MIRA Reveals Innovative Phase I/IIa Protocol Design and Selection of Clinical Trial Site
MIRA Pharmaceuticals (NASDAQ:MIRA) has selected The Centre for Human Drug Research (CHDR) in Leiden, Netherlands, for its Phase I/IIa clinical trial of Ketamir-2, a novel oral ketamine analog. The trial will begin recruitment in Q1 2025, with Phase I results expected in H2 2025 and Phase IIa results in H1 2026. The study will utilize CHDR's proprietary PainCart technology to measure pain response in healthy subjects during Phase I, followed by testing in diabetic neuropathy patients in Phase IIa. The trial is designed as a randomized, double-blind, placebo-controlled study. Ketamir-2 has shown superior efficacy compared to pregabalin and gabapentin in preclinical studies, with no reported side effects to date.
MIRA Pharmaceuticals (NASDAQ:MIRA) ha selezionato il Centre for Human Drug Research (CHDR) di Leiden, Paesi Bassi, per il suo studio clinico di Fase I/IIa su Ketamir-2, un nuovo analogo orale della ketamina. La reclutamento per lo studio inizierà nel primo trimestre del 2025, con risultati della Fase I attesi nel secondo semestre del 2025 e risultati della Fase IIa nel primo semestre del 2026. Lo studio utilizzerà la tecnologia proprietaria PainCart del CHDR per misurare la risposta al dolore in soggetti sani durante la Fase I, seguita da test su pazienti affetti da neuropatia diabetica nella Fase IIa. La sperimentazione è progettata come uno studio randomizzato, in doppio cieco e controllato con placebo. Ketamir-2 ha mostrato una maggiore efficacia rispetto a pregabalin e gabapentin negli studi preclinici, senza effetti collaterali riportati fino ad oggi.
MIRA Pharmaceuticals (NASDAQ:MIRA) ha seleccionado el Centre for Human Drug Research (CHDR) en Leiden, Países Bajos, para su ensayo clínico de Fase I/IIa de Ketamir-2, un nuevo análogo oral de la ketamina. El reclutamiento para el ensayo comenzará en el primer trimestre de 2025, con resultados de la Fase I esperados en el segundo semestre de 2025 y resultados de la Fase IIa en el primer semestre de 2026. El estudio utilizará la tecnología propietaria PainCart del CHDR para medir la respuesta al dolor en sujetos sanos durante la Fase I, seguido de pruebas en pacientes con neuropatía diabética en la Fase IIa. El ensayo está diseñado como un estudio aleatorizado, doble ciego y controlado con placebo. Ketamir-2 ha demostrado una eficacia superior en comparación con pregabalina y gabapentina en estudios preclínicos, sin efectos secundarios reportados hasta la fecha.
MIRA Pharmaceuticals (NASDAQ:MIRA)는 네덜란드 라이덴의 인간 약물 연구 센터(CHDR)를 Ketamir-2에 대한 1상/2a상 임상 시험의 기관으로 선택했습니다. 이 시험은 2025년 1분기에 모집을 시작하며, 1상 결과는 2025년 하반기에, 2a상 결과는 2026년 상반기에 예상됩니다. 연구는 1상에서 건강한 피험자들의 통증 반응을 측정하기 위해 CHDR의 독자적인 PainCart 기술을 사용할 것이며, 이어서 2a상에서 당뇨병성 신경병증 환자에 대한 시험이 진행됩니다. 이 시험은 무작위 배정, 이중 맹검 및 위약 대조 연구로 설계되었습니다. Ketamir-2는 전임상 연구에서 pregabalin 및 gabapentin에 비해 우수한 효능을 보여주었으며, 현재까지 보고된 부작용은 없습니다.
MIRA Pharmaceuticals (NASDAQ:MIRA) a sélectionné le Centre for Human Drug Research (CHDR) à Leiden, aux Pays-Bas, pour son essai clinique de Phase I/IIa sur Ketamir-2, un nouvel analogue oral de la kétamine. Le recrutement pour l'essai débutera au premier trimestre 2025, avec des résultats de la Phase I prévus pour le second semestre 2025 et des résultats de la Phase IIa au premier semestre 2026. L'étude utilisera la technologie propriétaire PainCart du CHDR pour mesurer la réponse à la douleur chez des sujets sains pendant la Phase I, suivie de tests chez des patients souffrant de neuropathie diabétique lors de la Phase IIa. L'essai est conçu comme une étude randomisée, en double aveugle et contrôlée par placebo. Ketamir-2 a montré une efficacité supérieure par rapport au pregabalin et à la gabapentine dans des études précliniques, sans effets secondaires signalés jusqu'à présent.
MIRA Pharmaceuticals (NASDAQ:MIRA) hat das Centre for Human Drug Research (CHDR) in Leiden, Niederlande, für seine Phase I/IIa-Studie zu Ketamir-2, einem neuartigen oralen Ketamin-Analogon, ausgewählt. Die Rekrutierung für die Studie beginnt im ersten Quartal 2025, die Ergebnisse der Phase I werden im zweiten Halbjahr 2025 und die Ergebnisse der Phase IIa im ersten Halbjahr 2026 erwartet. Die Studie wird die proprietäre PainCart-Technologie von CHDR nutzen, um die Schmerzreaktion bei gesunden Probanden in der Phase I zu messen, gefolgt von Tests bei Patienten mit diabetischer Neuropathie in der Phase IIa. Die Studie ist als randomisierte, doppelblinde, placebo-kontrollierte Studie konzipiert. Ketamir-2 hat in präklinischen Studien eine überlegene Wirksamkeit im Vergleich zu Pregabalin und Gabapentin gezeigt, ohne dass bisher Nebenwirkungen berichtet wurden.
- Early efficacy data collection enabled through PainCart technology in Phase I
- Superior preclinical performance compared to established drugs (pregabalin and gabapentin)
- Healthy balance sheet reported, reducing need for unfavorable financing
- Clear timeline established: Phase I results in H2 2025, Phase IIa results in H1 2026
- No side effects observed in preclinical studies to date
- Still in preclinical stage, with clinical trials not starting until Q1 2025
- Extended timeline to market with Phase IIa results not expected until H1 2026
Insights
The selection of CHDR and its PainCart® technology for MIRA's Phase I/IIa trial represents a strategic advantage in accelerating clinical development. The ability to gather efficacy data during Phase I using validated pain response measurements is particularly valuable, as it could provide early insights into Ketamir-2's therapeutic potential before moving to patient trials.
The dual-phase study design incorporating both SAD and MAD cohorts, followed by diabetic neuropathy patient trials, is well-structured to establish safety and efficacy profiles. However, investors should note that preclinical superiority over pregabalin and gabapentin needs validation in human trials. The timeline to initial results in H2 2025 and POC data in H1 2026 provides clear development milestones.
MIRA's market position as a preclinical-stage company with a
The selection of a European trial site could potentially reduce costs while maintaining high research standards. The comprehensive development strategy, including planned publications and partnership pursuits, indicates a well-rounded approach to building value.
Backed by a Strong Balance Sheet, MIRA Accelerates Toward Becoming a Clinical-Stage Company and Advancing Breakthroughs in Pain and Depression Treatment
MIAMI, FL / ACCESSWIRE / November 20, 2024 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA), a preclinical-stage pharmaceutical company, is pleased to announce the selection of The Centre for Human Drug Research (CHDR) in Leiden, The Netherlands, as the site for its Phase I/IIa clinical trial of Ketamir-2, a novel oral ketamine analog. Recruitment for the trial is set to begin in Q1 2025, with initial safety and efficacy results from the Phase I study in healthy subjects expected in the second half of 2025. The Phase IIa study, planned to start in Q4 2025, will focus on diabetic neuropathy patients, with initial human efficacy results anticipated in the first half of 2026.
The trial leverages CHDR's proprietary PainCart® technology, a validated tool for measuring pain response. This advanced technology allows MIRA to assess early signs of efficacy in healthy subjects during Phase I, a capability that is typically unavailable at this stage of development. Psychoactivity assessments will also be conducted separately as part of an independent evaluation. The unique capabilities of PainCart® was a key reason for selecting CHDR as the trial site, allowing MIRA to gain valuable insights into Ketamir-2's potential for pain management earlier in the clinical process together with information about safety and pharmacokinetics.
Innovative Study Design Focused on Early Proof-of-Concept Data
The Phase I/IIa trial is structured as a randomized, double-blind, placebo-controlled study conducted in two parts:
Phase I: Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) cohorts in healthy subjects will evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics. PainCart will be used to measure pain response, providing robust early efficacy data, while psychoactivity will be assessed separately through dedicated testing.
Phase IIa: The Proof of Concept (POC) study, planned to begin in the last quarter of 2025, will focus on diabetic neuropathy patients, generating efficacy data in a patient population to validate the Phase I findings.
"This innovative protocol is designed to deliver early, robust proof-of-concept data, advancing Ketamir-2's clinical development and positioning us for strategic partnerships or an M&A opportunity," said Erez Aminov, CEO and Chairman of MIRA Pharmaceuticals.
Dr. Itzchak Angel, Chief Scientific Advisor at MIRA Pharmaceuticals, stated, "the selection of CHDR and the incorporation of PainCart technology in this trial represent a significant step forward in Ketamir-2's development. The ability to gather early efficacy data in healthy subjects provides an invaluable opportunity to optimize the drug's potential and streamline its progress toward addressing the unmet needs in pain management. Our goal is to establish Ketamir-2 as a pioneering therapy in this space."
Ongoing Preclinical and Manufacturing Updates
MIRA continues to make significant progress in its broader pipeline. Preclinical studies for diabetic neuropathy and PTSD are ongoing, and the Company remains on track to complete its IND submission by year-end. Capsule manufacturing for the Phase I/IIa trial is also in its final stages, ensuring readiness for patient dosing in early 2025.
The Company is actively pursuing non-dilutive grant opportunities to support its research programs and is preparing multiple scientific journal publications detailing Ketamir-2's mechanism of action, preclinical results, and potential therapeutic applications. These efforts aim to enhance scientific understanding and attract additional resources for development.
Strong Financial Position and Strategic Focus
MIRA believes that it has a healthy balance sheet, and accordingly, is well-positioned to achieve its strategic goals without reliance on unfavorable financing deals. "We are committed to diligently pursuing strategic partnerships and ensuring the successful development of Ketamir-2 while exploring its potential for broader market applications," added Aminov.
Superior Efficacy and Safety: A Groundbreaking Therapy
Ketamir-2 has consistently outperformed several well-known drugs like pregabalin and gabapentin in preclinical studies, demonstrating superior efficacy and a strong safety profile. The drug is designed to address an urgent unmet need for safe, effective, and non-addictive treatments for pain and depression.
"Our focus on developing a non-addictive, safe, and highly effective solution for pain and depression addresses an urgent unmet need," said Aminov. "With no side effects observed to date, Ketamir-2 represents a promising breakthrough in pain management."
Looking Ahead
As MIRA transitions into a clinical-stage company, the team remains dedicated to advancing Ketamir-2 through rigorous clinical trials, building strategic partnerships, and exploring additional indications to maximize its therapeutic potential. MIRA will aim to achieve significant milestones in the months ahead as it continues to generate innovation in pain and depression treatment.
For more information, please visit 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 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.
Contact Information
Helga Moya
info@mirapharma.com
(786) 432-9792
SOURCE: MIRA Pharmaceuticals
View the original press release on accesswire.com
FAQ
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