MIRA Pharmaceuticals Enrolls First Subjects in Phase 1 Clinical Trial of Ketamir-2 for Neuropathic Pain
MIRA Pharmaceuticals (NASDAQ:MIRA) has initiated its Phase 1 clinical trial of Ketamir-2, enrolling the first subjects at Hadassah Medical Center in Jerusalem. The trial will evaluate this novel oral ketamine analog for neuropathic pain treatment across 56 subjects in Single and Multiple Ascending Dose cohorts.
Preclinical data showed Ketamir-2's superior efficacy compared to pregabalin and gabapentin, with strong safety profile and oral bioavailability, without ketamine's typical dissociative effects. The Phase 1 study is expected to complete by Q4 2025, followed by a Phase 2a trial in diabetic neuropathic pain patients.
MIRA is also developing a topical Ketamir-2 formulation and advancing the acquisition of SKNY Pharmaceuticals, which includes a $5 million capital infusion. The acquisition brings SKNY-1, a non-GLP-1 oral therapy for weight loss and smoking cessation, into MIRA's pipeline.
MIRA Pharmaceuticals (NASDAQ:MIRA) ha avviato il suo trial clinico di Fase 1 per Ketamir-2, arruolando i primi soggetti presso il Hadassah Medical Center di Gerusalemme. Lo studio valuterà questo nuovo analogo orale della ketamina per il trattamento del dolore neuropatico su un totale di 56 soggetti suddivisi in coorti di dosi singole e multiple ascendenti.
I dati preclinici hanno mostrato l'eccellente efficacia di Ketamir-2 rispetto a pregabalin e gabapentin, con un profilo di sicurezza robusto e una buona biodisponibilità orale, senza gli effetti dissociativi tipici della ketamina. Si prevede che lo studio di Fase 1 si concluda entro il quarto trimestre del 2025, seguito da un trial di Fase 2a su pazienti con dolore neuropatico diabetico.
MIRA sta anche sviluppando una formulazione topica di Ketamir-2 e sta portando avanti l'acquisizione di SKNY Pharmaceuticals, che include un'infusione di capitale di 5 milioni di dollari. L'acquisizione porta nel pipeline di MIRA SKNY-1, una terapia orale non-GLP-1 per la perdita di peso e la cessazione del fumo.
MIRA Pharmaceuticals (NASDAQ:MIRA) ha iniciado su ensayo clínico de Fase 1 para Ketamir-2, inscribiendo a los primeros sujetos en el Hadassah Medical Center de Jerusalén. El ensayo evaluará este nuevo análogo oral de ketamina para el tratamiento del dolor neuropático en 56 sujetos en cohortes de dosis única y múltiple ascendente.
Los datos preclínicos mostraron la superior eficacia de Ketamir-2 en comparación con pregabalina y gabapentina, con un fuerte perfil de seguridad y biodisponibilidad oral, sin los efectos disociativos típicos de la ketamina. Se espera que el estudio de Fase 1 se complete para el cuarto trimestre de 2025, seguido de un ensayo de Fase 2a en pacientes con dolor neuropático diabético.
MIRA también está desarrollando una formulación tópica de Ketamir-2 y avanzando en la adquisición de SKNY Pharmaceuticals, que incluye una inyección de capital de 5 millones de dólares. La adquisición incorpora a la línea de productos de MIRA SKNY-1, una terapia oral no-GLP-1 para la pérdida de peso y la cesación del tabaquismo.
MIRA Pharmaceuticals (NASDAQ:MIRA)는 Ketamir-2의 1상 임상 시험을 시작하였으며, 예루살렘의 하다사 병원에서 첫 번째 피험자를 등록하였습니다. 이 시험은 56명의 피험자를 대상으로 단일 및 다중 용량 상승 코호트에서 이 새로운 경구용 케타민 유사체의 신경병증 통증 치료 효과를 평가할 것입니다.
전임상 데이터는 Ketamir-2가 프레가발린 및 가바펜틴에 비해 우수한 효능을 보이며, 강력한 안전성 프로필과 경구 생체 이용률을 가지며, 케타민의 전형적인 해리 효과가 없음을 보여주었습니다. 1상 연구는 2025년 4분기까지 완료될 것으로 예상되며, 당뇨병성 신경병증 환자를 대상으로 한 2a상 시험이 이어질 것입니다.
MIRA는 또한 Ketamir-2의 국소 제형을 개발하고 있으며, 500만 달러의 자본 투입을 포함한 SKNY Pharmaceuticals의 인수를 진행하고 있습니다. 이 인수는 MIRA의 파이프라인에 체중 감소 및 금연을 위한 비 GLP-1 경구 치료제인 SKNY-1을 추가합니다.
MIRA Pharmaceuticals (NASDAQ:MIRA) a lancé son essai clinique de phase 1 pour Ketamir-2, en recrutant les premiers sujets au Hadassah Medical Center à Jérusalem. L'essai évaluera cet analogique oral novateur de la kétamine pour le traitement de la douleur neuropathique chez 56 sujets, répartis en cohortes de doses uniques et multiples ascendantes.
Les données précliniques ont montré l'efficacité supérieure de Ketamir-2 par rapport à la prégabaline et au gabapentin, avec un bon profil de sécurité et une biodisponibilité orale, sans les effets dissociatifs typiques de la kétamine. L'étude de phase 1 devrait se terminer d'ici le quatrième trimestre 2025, suivie d'un essai de phase 2a chez des patients souffrant de douleur neuropathique diabétique.
MIRA développe également une formulation topique de Ketamir-2 et avance dans l'acquisition de SKNY Pharmaceuticals, qui comprend une injection de capital de 5 millions de dollars. L'acquisition intègre SKNY-1, une thérapie orale non-GLP-1 pour la perte de poids et l'arrêt du tabac, dans le pipeline de MIRA.
MIRA Pharmaceuticals (NASDAQ:MIRA) hat seine Phase-1-Studie zu Ketamir-2 gestartet und die ersten Probanden im Hadassah Medical Center in Jerusalem rekrutiert. Die Studie wird dieses neuartige orale Ketamin-Analogon zur Behandlung von neuropathischen Schmerzen bei 56 Probanden in Einzel- und Mehrfachdosis-Kohorten evaluieren.
Präklinische Daten zeigten die überlegene Wirksamkeit von Ketamir-2 im Vergleich zu Pregabalin und Gabapentin, mit einem starken Sicherheitsprofil und oraler Bioverfügbarkeit, ohne die typischen dissoziativen Effekte von Ketamin. Die Phase-1-Studie soll bis zum vierten Quartal 2025 abgeschlossen sein, gefolgt von einer Phase-2a-Studie bei Patienten mit diabetischer Neuropathie.
MIRA entwickelt auch eine topische Formulierung von Ketamir-2 und schreitet mit der Übernahme von SKNY Pharmaceuticals voran, die eine Kapitalzufuhr von 5 Millionen Dollar umfasst. Die Übernahme bringt SKNY-1, eine nicht-GLP-1 orale Therapie zur Gewichtsreduktion und zum Rauchstopp, in MIRA's Pipeline.
- Successful initiation of Phase 1 trial for Ketamir-2
- Superior preclinical efficacy compared to existing treatments
- $5 million capital infusion through SKNY acquisition
- Pipeline expansion with topical Ketamir-2 formulation
- Addition of SKNY-1 weight loss drug to portfolio
- Phase 1 results not expected until Q4 2025
- Efficacy in humans yet to be demonstrated
- Multiple competitors already established in weight loss market
Insights
MIRA's initiation of Phase 1 trials for Ketamir-2 represents a significant developmental milestone, transitioning from preclinical to human studies. The randomized, double-blind, placebo-controlled design with 56 subjects across SAD/MAD cohorts follows gold-standard methodology for evaluating novel compounds.
The preclinical profile of Ketamir-2 is particularly compelling - demonstrating superior efficacy versus established treatments (pregabalin and gabapentin) while avoiding ketamine's typical dissociative effects. The compound's ability to cross the blood-brain barrier efficiently (not being a P-gp substrate) addresses a critical limitation in CNS drug development.
The company has outlined a clear clinical timeline with Phase 1 completion by Q4 2025 and Phase 2a initiation in diabetic neuropathic pain patients by year-end, positioning first efficacy data by H1 2026. This aggressive but realistic timeline reflects confidence in their preliminary safety data.
The parallel development of a topical formulation strategically expands their addressable market and intellectual property position, potentially offering localized treatment without systemic exposure - particularly valuable in pain management where targeted delivery can minimize side effects.
While positive, investors should recognize that early clinical success doesn't guarantee approval. Phase 1 focuses primarily on safety, not efficacy in patients, and neuropathic pain remains a challenging indication with substantial regulatory hurdles. The company must demonstrate differentiation from existing treatments to justify market adoption.
MIRA's announcement reveals a multi-pronged growth strategy centered on both internal development and strategic acquisition. The $5 million capital infusion through the SKNY Pharmaceuticals acquisition strengthens MIRA's financial position while diversifying their pipeline beyond neurological applications into the lucrative metabolic disease space.
The strategic timing of entering the weight management market is noteworthy, as the company is positioning SKNY-1 as a differentiated alternative to GLP-1 agonists like Wegovy and Saxenda. By highlighting their oral administration route and potential for fewer side effects, MIRA is targeting key limitations of current market leaders in a sector projected to reach $150+ billion by early 2030s.
From a business development perspective, MIRA is executing a balanced approach - advancing their lead neurological asset into clinical stages while simultaneously expanding through acquisition. This dual pathway reduces concentration risk and provides multiple potential value inflection points over the next 12-24 months.
The neuropathic pain market represents a substantial opportunity, with current treatments offering efficacy and problematic side effect profiles. If Ketamir-2 can deliver on its non-addictive promise with superior efficacy, it could capture significant market share in a condition affecting millions globally.
The company's focus on differentiated mechanisms and novel formulations demonstrates strategic foresight in building a sustainable competitive advantage rather than pursuing "me-too" approaches. However, execution risk remains high given their early clinical stage and relatively market capitalization of approximately $19 million.
MIAMI, FLORIDA / ACCESS Newswire / April 1, 2025 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA), a clinical-stage pharmaceutical company developing breakthrough therapeutics for neurologic and neuropsychiatric disorders, today announced the enrollment of the first subjects in its Phase 1 clinical trial of Ketamir-2, a novel oral ketamine analog in development for the treatment of neuropathic pain.
The Phase 1 trial is being conducted at the Clinical Pharmacology Unit of Hadassah Medical Center in Jerusalem, Israel. This randomized, double-blind, placebo-controlled study will assess the safety, tolerability, and pharmacokinetics of Ketamir-2 in healthy adult volunteers. A total of 56 subjects will be enrolled across both Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) cohorts.
This important clinical milestone follows compelling preclinical data, where Ketamir-2 demonstrated superior efficacy compared to FDA-approved neuropathic pain treatments, including pregabalin and gabapentin. It also showed a strong safety profile and oral bioavailability, without the dissociative or psychedelic effects commonly associated with ketamine. Additionally, Ketamir-2 is not a substrate for P-glycoprotein (P-gp), which supports its ability to efficiently cross the blood-brain barrier-a critical factor in treating central nervous system disorders.
"The Phase 1 trial is progressing smoothly and according to plan," said Dr. Itzchak Angel, Chief Scientific Advisor at MIRA. "Ketamir-2's unique mechanism and pharmacological profile make it a highly promising candidate for neuropathic pain. If successful, it could represent a safer, non-addictive alternative to opioids and a more effective option than current standard treatments like pregabalin and gabapentin."
Phase 1 Completion and Clinical Timeline
MIRA anticipates completing the Phase 1 study by Q4 2025. The Company plans to initiate a Phase 2a trial in patients with diabetic neuropathic pain by year-end, with first human efficacy data expected in the first half of 2026.
Expansion into Topical Ketamir-2 Formulation
MIRA has also successfully formulated a topical version of Ketamir-2, designed for slow-release, localized delivery in the treatment of inflammatory and neuropathic pain. This approach may offer targeted pain relief at the site of application while minimizing systemic exposure. Preclinical studies are ongoing to assess efficacy, with results expected to guide the next steps in clinical development.
Strategic Pipeline Growth Through SKNY Pharmaceuticals Acquisition
MIRA is also advancing the acquisition of SKNY Pharmaceuticals under a binding letter of intent. The transaction includes a
SKNY-1 is being developed as a novel, non-GLP-1 oral therapy that modulates cannabinoid receptor pathways to support metabolic regulation. If successful, SKNY-1 could provide a safer, more convenient, and cost-effective alternative in the growing global obesity market, projected to exceed
"Enrolling our first subjects in this Phase 1 study marks a pivotal step forward for MIRA," said Erez Aminov, Chairman and CEO of MIRA. "It validates years of focused research and execution. With the addition of our topical formulation, the SKNY acquisition, and a growing pipeline of novel compounds, we are building a multi-dimensional platform that aims to transform the way we treat pain, addiction, and chronic disease."
About MIRA Pharmaceuticals, Inc.
MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA) is a 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.
Contact Information
Helga Moya
info@mirapharma.com
(786) 432-9792
SOURCE: MIRA Pharmaceuticals
View the original press release on ACCESS Newswire
FAQ
When will MIRA Pharmaceuticals complete the Phase 1 trial of Ketamir-2?
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When will MIRA begin Phase 2a trials for Ketamir-2?
