MIRA Pharmaceuticals Announces Positive Results for Ketamir-2 in Diabetic Neuropathy Animal Model, Reinforcing Confidence Ahead of Phase I Completion
MIRA Pharmaceuticals (NASDAQ:MIRA) has announced positive results for its oral ketamine analog Ketamir-2 in a diabetic neuropathy animal model. The study demonstrated significant reduction in neuropathic pain symptoms, with some subjects achieving complete reversal to pre-diabetic baseline sensitivity.
The company is currently conducting a Phase I clinical trial at Hadassah Medical Center, with completion expected in Q4 2025. MIRA plans to initiate a Phase IIa trial in diabetic neuropathy patients by year-end, with first human efficacy data expected in H1 2026.
Ketamir-2 has shown superior performance compared to FDA-approved medications like pregabalin and gabapentin in preclinical studies. Unlike traditional ketamine, it doesn't cause dissociative effects and offers better blood-brain barrier penetration. The company is also developing a topical slow-release formulation and exploring applications for PTSD treatment.
MIRA Pharmaceuticals (NASDAQ:MIRA) ha annunciato risultati positivi per il suo analogo orale della ketamina, Ketamir-2, in un modello animale di neuropatia diabetica. Lo studio ha evidenziato una significativa riduzione dei sintomi del dolore neuropatico, con alcuni soggetti che hanno raggiunto un completo ritorno alla sensibilità basale pre-diabetica.
L'azienda sta attualmente conducendo uno studio clinico di Fase I presso l'Hadassah Medical Center, con completamento previsto per il quarto trimestre 2025. MIRA prevede di avviare uno studio di Fase IIa su pazienti con neuropatia diabetica entro la fine dell'anno, con i primi dati di efficacia sull'uomo attesi nella prima metà del 2026.
Ketamir-2 ha mostrato prestazioni superiori rispetto ai farmaci approvati dalla FDA come pregabalin e gabapentin negli studi preclinici. A differenza della ketamina tradizionale, non provoca effetti dissociativi e garantisce una migliore penetrazione nella barriera emato-encefalica. L'azienda sta inoltre sviluppando una formulazione topica a rilascio lento ed esplorando applicazioni per il trattamento del disturbo da stress post-traumatico (PTSD).
MIRA Pharmaceuticals (NASDAQ:MIRA) ha anunciado resultados positivos para su análogo oral de ketamina, Ketamir-2, en un modelo animal de neuropatía diabética. El estudio mostró una reducción significativa de los síntomas del dolor neuropático, con algunos sujetos que lograron una reversión completa a la sensibilidad basal previa a la diabetes.
La compañía está llevando a cabo un ensayo clínico de Fase I en el Hadassah Medical Center, con finalización prevista para el cuarto trimestre de 2025. MIRA planea iniciar un ensayo de Fase IIa en pacientes con neuropatía diabética antes de fin de año, con los primeros datos de eficacia en humanos esperados para la primera mitad de 2026.
Ketamir-2 ha demostrado un rendimiento superior en comparación con medicamentos aprobados por la FDA como pregabalina y gabapentina en estudios preclínicos. A diferencia de la ketamina tradicional, no causa efectos disociativos y ofrece mejor penetración en la barrera hematoencefálica. La empresa también está desarrollando una formulación tópica de liberación lenta y explorando aplicaciones para el tratamiento del trastorno de estrés postraumático (TEPT).
MIRA Pharmaceuticals (NASDAQ:MIRA)는 당뇨병성 신경병증 동물 모델에서 경구용 케타민 유사체 Ketamir-2의 긍정적인 결과를 발표했습니다. 연구 결과 신경병성 통증 증상이 크게 감소했으며, 일부 피험자는 당뇨병 이전의 정상 감각 상태로 완전 회복되었습니다.
회사는 현재 하다사 메디컬 센터에서 1상 임상시험을 진행 중이며, 2025년 4분기 완료를 목표로 하고 있습니다. MIRA는 연말까지 당뇨병성 신경병증 환자를 대상으로 2a상 시험을 시작할 계획이며, 인간 대상 첫 효능 데이터는 2026년 상반기에 나올 예정입니다.
Ketamir-2는 전임상 연구에서 FDA 승인 약물인 프레가발린과 가바펜틴보다 우수한 성능을 보였습니다. 전통적인 케타민과 달리 해리성 효과가 없으며 혈뇌장벽 투과율이 더 뛰어납니다. 회사는 또한 국소용 서방형 제형을 개발 중이며, 외상 후 스트레스 장애(PTSD) 치료 적용도 모색하고 있습니다.
MIRA Pharmaceuticals (NASDAQ:MIRA) a annoncé des résultats positifs pour son analogue oral de la kétamine, Ketamir-2, dans un modèle animal de neuropathie diabétique. L'étude a démontré une réduction significative des symptômes de la douleur neuropathique, certains sujets retrouvant une sensibilité de base équivalente à celle d'avant le diabète.
L'entreprise mène actuellement un essai clinique de phase I au centre médical Hadassah, dont l'achèvement est prévu pour le quatrième trimestre 2025. MIRA prévoit de lancer un essai de phase IIa chez des patients atteints de neuropathie diabétique d'ici la fin de l'année, avec les premières données d'efficacité humaine attendues au premier semestre 2026.
Ketamir-2 a montré des performances supérieures par rapport aux médicaments approuvés par la FDA tels que la prégabaline et la gabapentine lors des études précliniques. Contrairement à la kétamine traditionnelle, il ne provoque pas d'effets dissociatifs et offre une meilleure pénétration de la barrière hémato-encéphalique. L'entreprise développe également une formulation topique à libération lente et explore des applications pour le traitement du trouble de stress post-traumatique (TSPT).
MIRA Pharmaceuticals (NASDAQ:MIRA) hat positive Ergebnisse für seinen oralen Ketamin-Analogon Ketamir-2 in einem Tiermodell der diabetischen Neuropathie bekannt gegeben. Die Studie zeigte eine signifikante Verringerung der neuropathischen Schmerzsymptome, wobei einige Probanden eine vollständige Rückkehr zur prädiabetischen Basissensitivität erreichten.
Das Unternehmen führt derzeit eine Phase-I-Studie am Hadassah Medical Center durch, deren Abschluss für das vierte Quartal 2025 erwartet wird. MIRA plant, bis Jahresende eine Phase-IIa-Studie bei Patienten mit diabetischer Neuropathie zu starten, wobei erste Wirksamkeitsdaten am Menschen für das erste Halbjahr 2026 erwartet werden.
Ketamir-2 zeigte in präklinischen Studien eine überlegene Leistung im Vergleich zu von der FDA zugelassenen Medikamenten wie Pregabalin und Gabapentin. Im Gegensatz zu herkömmlichem Ketamin verursacht es keine dissoziativen Effekte und bietet eine bessere Penetration der Blut-Hirn-Schranke. Das Unternehmen entwickelt zudem eine topische Slow-Release-Formulierung und erforscht Anwendungen zur Behandlung von PTBS.
- Strong efficacy demonstrated in diabetic neuropathy animal model with complete symptom reversal in some subjects
- Superior performance compared to existing FDA-approved medications in preclinical studies
- Phase I trial progressing on schedule
- Potential for Fast Track and Breakthrough Therapy designation from FDA
- Development of additional topical formulation underway
- Phase I trial still ongoing with no human efficacy data yet
- Phase IIa trials won't begin until end of 2025
- Commercial launch timeline remains distant due to early development stage
Insights
MIRA's preclinical data for Ketamir-2 represents an important development in the diabetic neuropathy space, where current treatments offer efficacy for many patients. The animal model demonstrated significant reduction in neuropathic pain symptoms with some subjects achieving complete symptom reversal to baseline sensitivity - a particularly encouraging outcome.
Ketamir-2's differentiated profile is noteworthy: it's an oral ketamine analog without the dissociative/psychedelic effects of traditional ketamine and bypasses P-glycoprotein transport, potentially increasing blood-brain barrier penetration. Preclinical data suggests it outperforms FDA-approved pregabalin and gabapentin, current standard-of-care options that provide only modest relief for many patients.
The clinical development appears on track with Phase I dosing underway and completion expected in Q4 2025, followed by Phase IIa in diabetic neuropathy. The FDA's designation of neuropathic pain as high-priority could potentially accelerate approval pathways.
However, investors should recognize that preclinical efficacy often doesn't translate to humans, and the real value inflection points remain the Phase I safety data and eventually Phase II efficacy results in 2026. The diabetic neuropathy market represents substantial opportunity, affecting 28-55% of diabetes patients with $10+ billion in associated annual costs, but MIRA will need clinical validation to capture this potential.
MIRA's strategic positioning with Ketamir-2 appears well-aligned with multiple healthcare trends and market opportunities. The company is targeting diabetic neuropathy - a condition with high prevalence affecting up to 55% of diabetic patients worldwide and representing substantial unmet need given the limitations of current therapies.
Their approach addresses three convergent market dynamics: 1) increasing diabetes prevalence driving neuropathy cases, 2) growing demand for non-opioid pain solutions amid the ongoing opioid crisis, and 3) FDA prioritization of neuropathic pain treatments through potential accelerated pathways.
The company's pipeline expansion through the pending SKNY Pharmaceuticals acquisition adds strategic diversification with SKNY-1 targeting obesity and smoking cessation - both representing massive markets with satisfactory treatment options. This multi-indication strategy across both Ketamir-2 (neuropathy/PTSD) and the acquired SKNY-1 asset creates multiple potential value-creation pathways.
While the positive preclinical results strengthen MIRA's narrative, the most critical milestones remain ahead: Phase I completion in Q4 2025 and Phase IIa efficacy data in 2026. The development of a topical formulation could further expand addressable markets by providing localized treatment with minimized systemic exposure. For a company with
Ketamir-2 Demonstrates Strong Efficacy in Diabetic Neuropathy Model, with Some Subjects Achieving Complete Symptom Reversal
MIAMI, FLORIDA / ACCESS Newswire / April 16, 2025 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA), or MIRA, a clinical-stage pharmaceutical company focused on developing novel therapeutics for neurologic and neuropsychiatric disorders, today announced compelling data demonstrating the efficacy of the oral ketamine analog, Ketamir-2, in a validated animal model of diabetic neuropathy.
In the study, Type 2 diabetes was induced in rats using a high-fat diet combined with a low dose of Streptozotocin (STZ). This resulted in hyperglycemia and neuropathic symptoms, including hyperalgesia and allodynia, mimicking human diabetic pathology. By week 8, most diabetic rats exhibited sensory hypersensitivity. Treatment with Ketamir-2 led to a significant reduction in neuropathic pain symptoms, with some animals returning completely to pre-diabetic baseline sensitivity. "Millions of patients with diabetic neuropathy are left with limited, often ineffective treatment options," said Erez Aminov, Chairman and CEO of MIRA.
"With Ketamir-2, we're aiming to offer a non-opioid alternative that's not only safer but potentially more effective. We're currently advancing our Phase I study and plan to initiate a Phase IIa trial in diabetic neuropathy patients by year-end. Given that the FDA has designated neuropathic pain as a high-priority area for Fast Track and Breakthrough Therapy pathways, we believe Ketamir-2 is uniquely positioned to meet this urgent need and unlock significant clinical and commercial value."
Translational Data Strengthens Clinical Momentum
These results build upon prior preclinical studies using other neuropathy animal models, where orally administered Ketamir-2 outperformed FDA-approved neuropathic pain medications such as pregabalin and gabapentin, while also demonstrating a favorable safety profile. Unlike traditional ketamine, Ketamir-2 does not induce dissociative or psychedelic effects and is not a substrate for P-glycoprotein (P-gp), allowing for more efficient penetration across the blood-brain barrier. MIRA has already begun dosing and recruitment in its Phase I clinical trial at Hadassah Medical Center in Jerusalem. The study is progressing smoothly and on schedule. The randomized, double-blind, placebo-controlled trial is assessing safety, tolerability, and pharmacokinetics in healthy volunteers. Completion is expected in Q4 2025, with a Phase IIa study in diabetic neuropathy patients planned to follow.
"The strong alignment between this model and human pathology, together with results obtained with other experimental models, gives us a high degree of scientific confidence as we move forward," said Dr. Itzchak Angel, Chief Scientific Advisor at MIRA. "Seeing such robust responses in a validated model of diabetic neuropathy reinforces the potential clinical impact of Ketamir-2 and helps guide the path ahead."
Addressing a Pressing Unmet Need
Diabetic neuropathy affects between
Current treatment options are limited, with first-line therapies such as pregabalin, gabapentin, and duloxetine often delivering only modest symptom relief. These drugs are frequently associated with side effects such as dizziness, fatigue, cognitive impairment, and gastrointestinal discomfort. Up to
At the same time, the demand for non-opioid therapies is growing rapidly, driven by the ongoing opioid crisis and heightened regulatory scrutiny. Ketamir-2's non-addictive profile and lack of dissociative side effects position it as a strong candidate in this emerging treatment landscape.
The economic burden of diabetic neuropathy is also substantial. A study published in Drugs & Aging estimated that diabetic peripheral neuropathy contributes more than
(Gordois et al., Drugs Aging. 2003)
Importantly, the FDA has previously identified neuropathic pain as a high-priority area for accelerated development, granting Fast Track and Breakthrough Therapy designations to compounds that demonstrate potential to improve outcomes over standard treatments.
(FDA Guidance for Industry - Expedited Programs for Serious Conditions)
MIRA believes that, with continued positive data, Ketamir-2 may be positioned to meet key criteria for future regulatory acceleration.
Looking Ahead
MIRA anticipates initiating its Phase IIa clinical trial in diabetic neuropathy by the end of 2025, with first human efficacy data expected in the first half of 2026. In parallel, development of a topical slow-release formulation of Ketamir-2 continues, aimed at providing localized pain relief with minimized systemic exposure.
In addition, MIRA is actively conducting ongoing studies assessing the efficacy of Ketamir-2 in models of post-traumatic stress disorder (PTSD), a serious and underserved neuropsychiatric condition. MIRA remains committed to unlocking the full therapeutic potential of Ketamir-2 across multiple indications.
MIRA is also pleased to report continued progress on the pending acquisition of SKNY Pharmaceuticals, a move that strengthens MIRA's strategic pipeline. MIRA is highly enthusiastic about the promise of SKNY-1, a next-generation oral therapeutic in development for the treatment of obesity and smoking cessation, two major public health challenges that lack scalable, well-tolerated solutions.
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's 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 acquisition transaction and claims regarding SKNY-1. Any forward-looking statements in this press release are based on Mira'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 MIRA'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 MIRA'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 MIRA's website at https://www.mirapharmaceuticals.com/investors/sec-filings. MIRA 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
What are the key findings of MIRA's Ketamir-2 animal study for diabetic neuropathy?
When will MIRA complete the Phase I trial for Ketamir-2?
How does MIRA's Ketamir-2 differ from traditional ketamine?
What is MIRA's timeline for Phase IIa trials of Ketamir-2?
How does Ketamir-2 compare to existing neuropathy treatments?
