MIRA Reports Up to 30% Weight Loss and Reversal of High-Calorie and Nicotine Cravings in an Animal Model of Obesity and Craving Using SKNY-1, a Drug Candidate Under Definitive Agreement for Acquisition
MIRA (NASDAQ:MIRA) has announced promising results from animal studies of SKNY-1, an oral therapeutic candidate under definitive agreement for acquisition. The drug demonstrated up to 30% weight loss and reversed high-calorie and nicotine cravings in zebrafish models within six days of treatment.
Key findings include significant metabolic improvements without muscle loss, normalized liver fat and cholesterol levels, and reduced appetite and nicotine-seeking behaviors. The drug achieved these results through selective modulation of CB1 receptors and activation of CB2 receptors, while maintaining a favorable safety profile.
SKNY-1 is being developed as an oral alternative to GLP-1 injectables, addressing limitations of current obesity and smoking cessation treatments. The compound's unique mechanism targets a combined global market opportunity exceeding $200 billion. Following the acquisition of SKNY Pharmaceuticals, Inc., MIRA plans to advance SKNY-1 toward IND-enabling studies.
MIRA (NASDAQ:MIRA) ha annunciato risultati promettenti dagli studi su animali relativi a SKNY-1, un candidato terapeutico orale in fase di acquisizione definitiva. Il farmaco ha mostrato fino al 30% di perdita di peso e ha invertito le voglie di cibi ad alto contenuto calorico e di nicotina nei modelli di zebrafish entro sei giorni di trattamento.
I risultati chiave includono significativi miglioramenti metabolici senza perdita muscolare, normalizzazione dei livelli di grasso epatico e colesterolo, oltre a una riduzione dell’appetito e dei comportamenti di ricerca della nicotina. Il farmaco ha ottenuto questi effetti attraverso la modulazione selettiva dei recettori CB1 e l’attivazione dei recettori CB2, mantenendo un profilo di sicurezza favorevole.
SKNY-1 è sviluppato come alternativa orale agli iniettabili GLP-1, superando le limitazioni dei trattamenti attuali per obesità e cessazione del fumo. Il meccanismo unico del composto mira a un’opportunità di mercato globale combinata superiore a 200 miliardi di dollari. Dopo l’acquisizione di SKNY Pharmaceuticals, Inc., MIRA intende portare SKNY-1 verso studi abilitanti IND.
MIRA (NASDAQ:MIRA) ha anunciado resultados prometedores de estudios en animales con SKNY-1, un candidato terapéutico oral bajo un acuerdo definitivo de adquisición. El medicamento demostró hasta un 30% de pérdida de peso y revirtió los antojos de alimentos altos en calorías y nicotina en modelos de pez cebra en seis días de tratamiento.
Los hallazgos clave incluyen mejoras metabólicas significativas sin pérdida muscular, normalización de los niveles de grasa hepática y colesterol, y reducción del apetito y comportamientos de búsqueda de nicotina. El fármaco logró estos resultados mediante la modulación selectiva de los receptores CB1 y la activación de los receptores CB2, manteniendo un perfil de seguridad favorable.
SKNY-1 se está desarrollando como una alternativa oral a los inyectables GLP-1, abordando las limitaciones de los tratamientos actuales para la obesidad y la cesación del tabaquismo. El mecanismo único del compuesto apunta a una oportunidad de mercado global combinada que supera los 200 mil millones de dólares. Tras la adquisición de SKNY Pharmaceuticals, Inc., MIRA planea avanzar con SKNY-1 hacia estudios habilitantes IND.
MIRA (NASDAQ:MIRA)는 SKNY-1의 동물 실험에서 유망한 결과를 발표했습니다. SKNY-1은 인수 확정 계약 중인 경구용 치료 후보 물질입니다. 이 약물은 치료 6일 이내에 제브라피쉬 모델에서 최대 30% 체중 감소와 고칼로리 및 니코틴 갈망의 반전을 보여주었습니다.
주요 발견 사항으로는 근육 손실 없이 유의미한 대사 개선, 정상화된 간 지방 및 콜레스테롤 수치, 식욕 및 니코틴 탐색 행동 감소가 포함됩니다. 이 약물은 CB1 수용체의 선택적 조절과 CB2 수용체의 활성화를 통해 이러한 결과를 달성했으며, 안전성 프로필도 우수하게 유지되었습니다.
SKNY-1은 GLP-1 주사제의 경구 대안으로 개발 중이며, 현재 비만 및 금연 치료의 한계를 극복하고자 합니다. 이 화합물의 독특한 작용 기전은 2000억 달러가 넘는 전 세계 시장 기회를 겨냥합니다. SKNY Pharmaceuticals, Inc. 인수 후 MIRA는 SKNY-1을 IND 승인 전 단계 연구로 진행할 계획입니다.
MIRA (NASDAQ:MIRA) a annoncé des résultats prometteurs issus d’études animales sur SKNY-1, un candidat thérapeutique oral en cours d’acquisition définitive. Le médicament a démontré jusqu’à 30 % de perte de poids et a inversé les envies de calories élevées et de nicotine dans des modèles de poisson-zèbre en six jours de traitement.
Les résultats clés incluent des améliorations métaboliques significatives sans perte musculaire, une normalisation des taux de graisse hépatique et de cholestérol, ainsi qu’une réduction de l’appétit et des comportements de recherche de nicotine. Le médicament a obtenu ces résultats grâce à une modulation sélective des récepteurs CB1 et à l’activation des récepteurs CB2, tout en maintenant un profil de sécurité favorable.
SKNY-1 est développé comme une alternative orale aux injectables GLP-1, répondant aux limites des traitements actuels contre l’obésité et le sevrage tabagique. Le mécanisme unique du composé cible une opportunité de marché mondiale combinée dépassant 200 milliards de dollars. Suite à l’acquisition de SKNY Pharmaceuticals, Inc., MIRA prévoit de faire progresser SKNY-1 vers des études permettant l’IND.
MIRA (NASDAQ:MIRA) hat vielversprechende Ergebnisse aus Tierversuchen mit SKNY-1 bekannt gegeben, einem oralen Therapiekandidaten, der im Rahmen einer endgültigen Übernahmevereinbarung steht. Das Medikament zeigte innerhalb von sechs Behandlungstagen bis zu 30% Gewichtsverlust und kehrte das Verlangen nach kalorienreichen Lebensmitteln und Nikotin in Zebrafischmodellen um.
Wichtige Erkenntnisse umfassen signifikante metabolische Verbesserungen ohne Muskelverlust, normalisierte Leberfett- und Cholesterinwerte sowie eine Verringerung von Appetit und nikotinsuchendem Verhalten. Das Medikament erzielte diese Ergebnisse durch selektive Modulation der CB1-Rezeptoren und Aktivierung der CB2-Rezeptoren, wobei es ein günstiges Sicherheitsprofil beibehielt.
SKNY-1 wird als orale Alternative zu GLP-1-Injektionen entwickelt und adressiert die Einschränkungen aktueller Behandlungen für Adipositas und Rauchentwöhnung. Der einzigartige Wirkmechanismus des Wirkstoffs richtet sich auf eine kombinierte globale Marktchance von über 200 Milliarden US-Dollar. Nach der Übernahme von SKNY Pharmaceuticals, Inc. plant MIRA, SKNY-1 in Richtung IND-fähiger Studien voranzutreiben.
- Achieved significant 30% weight loss within 6 days of oral treatment
- Demonstrated fat reduction while preserving muscle mass, unlike GLP-1 alternatives
- Normalized liver fat and cholesterol levels to healthy ranges
- Successfully reduced both high-calorie and nicotine cravings
- Targets combined market opportunity exceeding $200 billion
- Offers oral administration versus injectable GLP-1 alternatives
- Showed favorable safety profile through selective receptor modulation
- Results limited to animal studies in zebrafish models only
- Still requires completion of acquisition and IND-enabling studies
- High-dose treatment showed different dopamine effects compared to low-dose
Insights
MIRA's SKNY-1 shows promising dual activity for obesity and smoking cessation with muscle preservation, though still in early animal testing phase.
MIRA's preclinical data for SKNY-1 reveals intriguing results in a zebrafish obesity model, with
The data package includes several noteworthy findings beyond just weight loss: preserved muscle density (addressing a key limitation of GLP-1s), normalized liver fat, improved cholesterol profiles, reduced compulsive eating behaviors, and decreased nicotine-seeking behaviors. The compound also demonstrated normalization of leptin and ghrelin levels, suggesting potential restoration of hormonal balance controlling appetite.
However, several critical limitations must be considered. This study used zebrafish models, which while useful for initial screening, represent an extremely preliminary stage of development far removed from human trials. The six-day treatment duration is extremely short compared to clinical obesity trials that typically run 6-12 months. The company has not yet filed an IND application, meaning human trials are not imminent, and years of development work remain before potential commercialization.
The selective pharmacology approach targeting CB1 receptors carries both promise and risk, as first-generation CB1 antagonists like rimonabant were withdrawn due to psychiatric side effects. MIRA's claim of reduced CNS engagement will require extensive clinical validation. Nonetheless, with obesity and smoking representing a
Oral therapy designed to minimize CNS side effects shows dual activity in weight loss and smoking cessation models without muscle loss
MIAMI, FLORIDA / ACCESS Newswire / June 30, 2025 / MIRA (NASDAQ:MIRA) today announced new animal study results from SKNY-1, a next-generation oral therapeutic under definitive agreement for acquisition. In a zebrafish model that mimics human obesity and craving behaviors, SKNY-1 demonstrated weight loss, suppression of appetite and craving for high-calorie diets, and reversal of nicotine-seeking behavior-all achieved within six days of oral treatment.
SKNY-1 is being developed as an oral alternative to GLP-1 injectables, which are often limited by nausea, GI discomfort, injection reaction, and growing concerns around muscle loss. Unlike GLP-1s, which reduce both fat and lean mass, SKNY-1 demonstrated significant weight loss with preserved muscle. It was specifically designed to minimize engagement with central nervous system pathways implicated in the psychiatric side effects observed in some smoking cessation therapies and first-generation CB1-targeting weight-loss drugs. The data support SKNY-1's potential as a differentiated oral therapy addressing two of the world's leading causes of preventable death.
The study was conducted in an obesity and craving model in Ob42 Strain-mc4r (G894C) mutated zebrafish following six days of oral treatment with two doses of SKNY-1 and was compared to normal controls.
Key Results
Weight Loss and Muscle Preservation:
SKNY-1 reduced body weight by approximately
Metabolic Activity and Ventilation Rate:
Treated animals showed an increase in breathing rate, which is a reliable signal that their metabolism was speeding up. This aligns with the observed weight loss and suggests that SKNY-1 helps the body burn more energy.
Liver and Lipid Profile Improvements:
In untreated obese animals, fat buildup in the liver was about
Appetite, Craving, and Compulsive Eating:
Obese animals were eating 2-3 times more high-calorie food than normal. SKNY-1 dose-dependently reduced this behavior-high-dose animals ate less than healthy controls. The drug also made the animals less likely to pursue food in stressful environments and reduced obsessive food-seeking in tests designed to measure craving.
Nicotine Craving and Compulsivity:
SKNY-1 significantly reduced the desire to seek out and consume nicotine. Treated animals were less willing to pursue nicotine even in stressful conditions, and they no longer showed a preference for environments linked to nicotine rewards. At the high dose, their behavior matched that of healthy animals with no nicotine craving.
Neurohormonal Balance:
Obese animals had extremely high levels of leptin (a hunger-regulating hormone) and unusually low levels of ghrelin (the 'hunger signal'). This imbalance often leads to constant hunger and poor appetite control. SKNY-1 normalized both hormones, improving the body's ability to regulate hunger and energy use.
Brain Dopamine Regulation:
Obese animals had too much dopamine in the brain, likely tied to increased reward and cravings. SKNY-1 reduced these dopamine levels-but only at the lower dose. The high dose did not affect dopamine, suggesting the drug can reduce craving without overstimulating the brain.
"Within just six days, we saw robust behavioral, hormonal and metabolic changes, including weight loss, improved fat metabolism, and reversal of craving-like behaviors," said Dr. Itzchak Angel, Chief Scientific Advisor at MIRA. "These results highlight SKNY-1's potential to address both obesity and nicotine addiction through unique and safe pathways."
A Differentiated Approach to Two Major Markets
Current weight-loss therapies like semaglutide and tirzepatide are effective but limited by gastrointestinal side effects, injectable administration, and loss of lean mass. Smoking cessation treatments such as varenicline and bupropion carry psychiatric warnings and offer modest long-term quit rates.
SKNY-1 was designed to overcome these limitations. It selectively modulates CB1 receptors by blocking β-arrestin signaling-associated with cravings and compulsive behavior-while preserving G-protein signaling, which supports emotional and cognitive stability. The compound also activates CB2 receptors and mildly inhibits MAO-B without affecting MAO-A, supporting a favorable safety and tolerability profile.
"These results position SKNY-1 as a potentially disruptive oral treatment," said Erez Aminov, CEO of MIRA. "Its ability to reduce body mass, suppress cravings, and preserve muscle-all through oral administration-makes it a compelling therapeutic candidate as we move toward closing the acquisition and preparing for IND-enabling studies."
The Company believes these findings further support the advancement of SKNY-1 toward Investigational New Drug (IND)-enabling studies. With obesity and smoking representing two of the leading causes of preventable death-and a combined global market opportunity exceeding
About MIRA Pharmaceuticals, Inc.
MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA) is a clinical-stage pharmaceutical company focused on the development and commercialization of novel therapeutics for neurologic, neuropsychiatric, and metabolic disorders. The Company's pipeline includes oral drug candidates designed to address significant unmet medical needs in areas such as anxiety, cognitive decline, neuropathic pain, obesity, and addiction.
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
FAQ
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