MIRA Pharmaceuticals Reports Positive PTSD Data Demonstrating Ketamir-2 Restores Normalized Behavior in Stressed Animals
MIRA Pharmaceuticals (NASDAQ:MIRA) has reported positive results for its oral drug candidate Ketamir-2 in a PTSD animal model study. The drug successfully restored normalized behavior in stressed rats using the Single Prolonged Stress (SPS) model, demonstrating potential efficacy for PTSD treatment.
The study showed that Ketamir-2, currently in Phase 1 clinical trials for neuropathic pain, reversed PTSD-like behaviors in animals after five days of oral administration. This development is significant given that PTSD affects 13 million U.S. adults annually, with an economic burden of $232 billion, and only two FDA-approved medications currently available.
MIRA Pharmaceuticals (NASDAQ:MIRA) ha riportato risultati positivi per il suo candidato a farmaco orale in uno studio su modello animale di PTSD. Il farmaco ha riportato con successo comportamenti normalizzati in ratti stressati utilizzando il modello di Stress Prolungato Singolo (Single Prolonged Stress, SPS), dimostrando potenziale efficacia nel trattamento del PTSD.
Lo studio ha mostrato che Ketamir-2, attualmente in trial clinici di fase 1 per dolore neuropatico, ha invertito comportamenti simili al PTSD negli animali dopo cinque giorni di somministrazione orale. Questo sviluppo è significativo poiché il PTSD colpisce 13 milioni di adulti statunitensi all'anno, con un onere economico di 232 miliardi di dollari, e attualmente sono disponibili solo due farmaci approvati dalla FDA.
MIRA Pharmaceuticals (NASDAQ:MIRA) ha informado resultados positivos para su candidato a fármaco oral Ketamir-2 en un estudio con modelo animal de TEPT. El fármaco logró restaurar con éxito un comportamiento normal en ratas estresadas utilizando el modelo de Estrés Prolongado Único (Single Prolonged Stress, SPS), demostrando potencial eficacia para el tratamiento del TEPT.
El estudio mostró que Ketamir-2, actualmente en ensayos clínicos de fase 1 para dolor neuropático, invirtió comportamientos similares al TEPT en animales tras cinco días de administración oral. Este avance es significativo ya que el TEPT afecta a 13 millones de adultos estadounidenses cada año, con una carga económica de $232 mil millones, y actualmente solo hay dos medicamentos aprobados por la FDA.
MIRA Pharmaceuticals(NASDAQ:MIRA)는 PTSD 동물 모델 연구에서 경구 약물 후보 Ketamir-2에 대한 긍정적 결과를 보고했습니다. 이 약물은 Single Prolonged Stress(SPS) 모델을 사용하여 스트레스를 받은 쥐에서 정상적 행동을 성공적으로 회복시켜 PTSD 치료에 대한 잠재적 효과를 보여주었습니다.
연구에 따르면 Ketamir-2는 현재 neuropathic pain에 대해 1상 임상 시험 중이며, 동물에서 PTSD와 유사한 행동을 5일간의 경구 투여 후 역전시켰습니다. 이 발전은 PTSD가 매년 미국 성인 1,300만 명에 영향을 미치고 경제적 부담이 $2320억 달러에 달한다는 점을 고려할 때 의미가 큽니다. FDA가 승인한 약물은 현재 두 가지뿐입니다.
MIRA Pharmaceuticals (NASDAQ:MIRA) a publié des résultats positifs pour son candidat médicament oral Ketamir-2 dans une étude sur un modèle animal de PTSD. Le médicament a restauré avec succès un comportement normal chez des rats stressés en utilisant le modèle de Stress Prolongé Unique (Single Prolonged Stress, SPS), démontrant un potentiel d'efficacité pour le traitement du PTSD.
L'étude a montré que Ketamir-2, actuellement en essais cliniques de phase 1 pour la douleur neuropathique, a inversé des comportements semblables au PTSD chez les animaux après cinq jours d'administration orale. Cette avancée est significative étant donné que le PTSD touche 13 millions d'adultes américains chaque année, avec une charge économique de $232 milliards, et qu'il n'existe actuellement que deux médicaments approuvés par la FDA.
MIRA Pharmaceuticals (NASDAQ:MIRA) hat positive Ergebnisse für seinen oralen Arzneimittelkandidaten Ketamir-2 in einer PTSD-Tiermodell-Studie gemeldet. Das Medikament stellte erfolgreich normales Verhalten bei gestressten Ratten wieder her, unter Verwendung des Single Prolonged Stress (SPS)-Modells, und zeigte damit potenzielle Wirksamkeit bei der Behandlung von PTSD.
Die Studie zeigte, dass Ketamir-2, derzeit in Phase-1-Studien für neuropathische Schmerzen, nach fünf Tagen oraler Verabreichung PTSD-ähnliche Verhaltensweisen bei Tieren umkehrte. Diese Entwicklung ist bedeutsam, da PTSD jährlich 13 Millionen US-Erwachsene betrifft, mit einer wirtschaftlichen Belastung von $232 Milliarden, und derzeit nur zwei von der FDA zugelassene Medikamente verfügbar sind.
أبلغت MIRA Pharmaceuticals (NASDAQ:MIRA) عن نتائج إيجابية لمرشحها الفموي Ketamir-2 في دراسة نموذج حيواني لاضطراب ما بعد الصدمة (PTSD). لقد استعاد الدواء بنجاح السلوك الطبيعي في فئران عرضة للإجهاد باستخدام نموذج الإجهاد المطول المفرد (Single Prolonged Stress, SPS)، ما يظهر إمكانية فعالية في علاج PTSD.
أظهرت الدراسة أن Ketamir-2، الذي يُجرى حاليًا في تجارب سريرية من المرحلة 1 لعلاج الألم العصبي، عكس سلوكيات مشابهة لـ PTSD في الحيوانات بعد خمسة أيام من الإعطاء الفموي. هذا التطور مهم نظرًا لأن PTSD يؤثر على 13 مليون بالغ أمريكي سنويًا، بتكلفة اقتصادية تبلغ $232 مليار، ومع وجود فقط اثنين من الأدوية المعتمدة من FDA.
MIRA Pharmaceuticals（纳斯达克股票代码:MIRA）已在PTSD动物模型研究中就其口服药物候选Ketamir-2报告了积极结果。该药物在使用单一强化压力（Single Prolonged Stress, SPS）模型的实验中成功恢复了受压迫大鼠的正常行为，显示出对PTSD治疗的潜在疗效。
研究表明， Ketamir-2目前在阶段1临床试验用于神经痛治疗，五天口服给药后在动物中逆转了PTSD样行为。这一进展具有重要意义，因为PTSD每年影响大约1300万美国成年人，经济负担约为$2320亿美元，目前只有两种经FDA批准的药物可用。
- Ketamir-2 successfully restored normalized behavior in PTSD animal model study
- Drug shows potential for dual indications: neuropathic pain and PTSD
- Favorable safety profile observed in ongoing Phase 1 clinical trial
- Large market opportunity with PTSD affecting 13 million U.S. adults annually
- Results are preliminary and based on a small group of rats
- Early-stage research requiring additional validation studies
- Competitive market with existing FDA-approved treatments
Insights
MIRA's Ketamir-2 shows promising PTSD results in preclinical studies while also advancing in Phase 1 trials for neuropathic pain.
The preclinical data for Ketamir-2 represents a notable scientific development in PTSD research. Using the Single Prolonged Stress (SPS) model, a validated paradigm for PTSD-like symptoms in animals, MIRA demonstrated that Ketamir-2 could reverse stress-induced behavioral abnormalities. The study measured immobility versus active coping strategies in the forced swim test (FST), with treated animals showing restoration toward normal behavior patterns.
What's particularly significant is that these results were achieved with oral administration over just five days, suggesting potentially rapid onset of action compared to existing SSRI treatments that typically require weeks to show effect. The mechanism appears to target stress resilience pathways rather than just symptom suppression.
The technical approach is scientifically sound, employing established behavioral testing methodologies. However, it's important to note this was a small initial validation study with a follow-on study still ongoing. While promising, the transition from rodent models to human efficacy in PTSD has historically been challenging due to the complex psychosocial components of the disorder.
From a pipeline perspective, this positions MIRA to potentially address two distinct therapeutic areas with the same compound - neuropathic pain and PTSD - which represents efficient use of R&D resources. The established safety profile from the ongoing Phase 1 pain trial could accelerate development for PTSD indications if consistent.
The PTSD treatment landscape represents a significant market opportunity with limited innovation. With
The company's mention of pursuing military and government collaborations is particularly noteworthy. Department of Defense and Veterans Affairs funding could provide non-dilutive capital for development while establishing institutional relationships critical for eventual adoption. Military-related PTSD represents a concentrated patient population with dedicated funding streams and institutional support.
From a competitive standpoint, MIRA has identified a differentiated approach in a field where innovation has been slow. Current SSRI treatments for PTSD show response rates of only
The dual-indication strategy also creates multiple potential value inflection points. With Ketamir-2 already in Phase 1 for neuropathic pain showing favorable safety, the regulatory pathway for a PTSD indication could be streamlined. This approach maximizes the return on investment for a single compound while diversifying risk across therapeutic areas.
While these preclinical results are promising, investors should note that the path to commercialization remains long, with significant clinical validation still required in human PTSD studies.
MIRA advances Ketamir-2 in the clinic for neuropathic pain while broadening development into neuropsychiatric disorders such as PTSD
MIAMI, FLORIDA / ACCESS Newswire / September 16, 2025 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA) ("MIRA" or the "Company"), a clinical-stage pharmaceutical company developing novel oral therapeutics for neurologic, neuropsychiatric, and metabolic disorders, today announced positive results demonstrating that its oral drug candidate Ketamir-2 restored normalized behavior in stressed animals within a validated model of post-traumatic stress disorder (PTSD). Ketamir-2 is currently being evaluated in an ongoing Phase 1 clinical trial for neuropathic pain, where it has shown a favorable safety profile to date.
"Restoring behavior to normal in a stressed PTSD model represents an important step forward," said Erez Aminov, CEO of MIRA Pharmaceuticals. "These findings support our decision to broaden the scientific evaluation of Ketamir-2 beyond neuropathic pain into neuropsychiatric disorders such as PTSD. Looking ahead, we plan to explore opportunities for potential collaborations, including with military and government institutions, given the significant unmet need for effective PTSD treatments."
This proof-of-concept validation study was conducted in a small group of rats using the Single Prolonged Stress (SPS) model, a widely accepted paradigm for inducing inescapable stress that mimics PTSD symptoms in animals. Animals were exposed twice to a predator stressor (bobcat urine), which is known to induce "depression-like" symptoms and changes in active/passive coping. Increased immobility after stress exposure reflects enhanced affective impairment or reduced stress resilience. Following the development of these symptoms, animals were dosed orally with Ketamir-2 once daily for five consecutive days.
Behavioral assessments included anxiety- and coping/resilience-related behavior in the forced swim test (FST), which measures immobility versus active coping strategies.
Outcome: stressed animals displayed hallmark PTSD-like behaviors, including increased despair, immobility, and avoidance of coping. Treatment with Ketamir-2 reversed these types of behaviors, restoring them toward the level observed in non-stressed animals. This initial validation supports the study design, and a larger follow-on PTSD study is ongoing.
"These preliminary results reinforce the therapeutic potential of Ketamir-2 in PTSD," said Dr. Itzchak Angel, Chief Scientific Advisor of MIRA. "We observed consistent reversal of stress-induced behavioral changes, supporting continued investigation of Ketamir-2 across neuropsychiatric disorders."
PTSD: A Major Unmet Need
PTSD affects an estimated 13 million adults in the United States each year, with approximately
6% of U.S. adults experiencing PTSD at some point in their lives.The economic and social burden of PTSD is estimated at
$232 billion annually in the U.S., driven by lost productivity, medical care, and disability.The treatment landscape is limited:
Only two FDA-approved medications exist for PTSD (sertraline and paroxetine, both SSRIs), which provide limited relief and are often poorly tolerated (FDA PTSD treatments).
Psychotherapies such as CBT and EMDR can be effective, but access, adherence, and dropout rates remain significant challenges.
The U.S. Department of Defense and Veterans Affairs continue to invest heavily in novel PTSD research, underscoring the urgent need for safer and more effective solutions for service members and veterans.
About Ketamir-2
Ketamir-2 is a proprietary, orally bioavailable new molecular entity that selectively targets the NMDA receptor (PCP site) with low affinity and demonstrates no significant off-target activity across a broad receptor panel. Ketamir-2 was designed to capture the therapeutic efficacy of ketamine while minimizing the unwanted dissociative and other central nervous system side effects that limit ketamine's clinical use. The U.S. Drug Enforcement Administration's scientific review of Ketamir-2 concluded that it would not be considered a controlled substance or listed chemical under the Controlled Substances Act and its governing regulations. Previous animal studies have also shown Ketamir-2's superior efficacy versus ketamine, pregabalin, and gabapentin in neuropathic pain models.
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. 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, including related to MIRA's potential merger with SKNY Pharmaceuticals, Inc. 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 the Form 14A filed by MIRA on June 18, 2025, and other SEC filings, which are on file with the SEC at www.sec.gov and on 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:
Helga Moya
info@mirapharma.com
(786) 432-9792
SOURCE: MIRA Pharmaceuticals
View the original press release on ACCESS Newswire
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