MIRA Pharmaceuticals Announces New Data Underscoring Potential of SKNY-1 - A Drug Candidate Pending Acquisition - To Disrupt Weight Loss and Smoking Cessation Markets Without CNS Side Effects
MIRA Pharmaceuticals (NASDAQ:MIRA) has revealed promising new in vitro preclinical data for SKNY-1, a novel drug candidate pending acquisition through SKNY Pharmaceuticals. The oral therapy targets both weight loss and smoking cessation markets through a dual-receptor strategy.
SKNY-1 functions as a biased CB1 modulator and partial CB2 agonist, designed to avoid the psychiatric side effects that led to the withdrawal of previous cannabinoid-based therapies. The drug selectively blocks β-arrestin signaling while preserving G-protein signaling, potentially enabling weight reduction and decreased cravings without mood disruption.
The compound also features mild MAO-B inhibition for dopamine regulation, positioning it as a differentiated alternative to injectable GLP-1 drugs. The global obesity drug market is projected to exceed $150 billion by 2030, while the U.S. smoking cessation market is expected to grow from $28 billion in 2024 to over $50 billion by decade's end.
MIRA Pharmaceuticals (NASDAQ:MIRA) ha presentato nuovi dati preclinici in vitro promettenti per SKNY-1, un nuovo candidato farmaco in attesa di acquisizione tramite SKNY Pharmaceuticals. La terapia orale mira sia al mercato della perdita di peso che a quello della cessazione del fumo attraverso una strategia a doppio recettore.
SKNY-1 agisce come modulatore selettivo del recettore CB1 e agonista parziale del CB2, progettato per evitare gli effetti collaterali psichiatrici che hanno causato il ritiro delle precedenti terapie a base di cannabinoidi. Il farmaco blocca selettivamente la segnalazione β-arrestina mantenendo quella del G-protein, potenzialmente consentendo la riduzione del peso e la diminuzione delle voglie senza alterazioni dell'umore.
Il composto presenta inoltre una lieve inibizione della MAO-B per la regolazione della dopamina, posizionandosi come un'alternativa differenziata ai farmaci iniettabili GLP-1. Si prevede che il mercato globale dei farmaci per l'obesità supererà i 150 miliardi di dollari entro il 2030, mentre il mercato statunitense per la cessazione del fumo crescerà da 28 miliardi di dollari nel 2024 a oltre 50 miliardi entro la fine del decennio.
MIRA Pharmaceuticals (NASDAQ:MIRA) ha revelado nuevos datos preclínicos in vitro prometedores para SKNY-1, un nuevo candidato a medicamento pendiente de adquisición a través de SKNY Pharmaceuticals. La terapia oral apunta tanto a los mercados de pérdida de peso y cesación del tabaquismo mediante una estrategia de doble receptor.
SKNY-1 funciona como un modulador sesgado del CB1 y agonista parcial del CB2, diseñado para evitar los efectos secundarios psiquiátricos que llevaron a la retirada de terapias anteriores basadas en cannabinoides. El medicamento bloquea selectivamente la señalización de β-arrestina mientras preserva la señalización de proteínas G, lo que podría permitir la reducción de peso y la disminución de antojos sin alterar el estado de ánimo.
El compuesto también presenta una inhibición leve de la MAO-B para la regulación de la dopamina, posicionándolo como una alternativa diferenciada a los medicamentos inyectables GLP-1. Se proyecta que el mercado global de medicamentos para la obesidad superará los 150 mil millones de dólares para 2030, mientras que el mercado estadounidense de cesación del tabaquismo crecerá de 28 mil millones de dólares en 2024 a más de 50 mil millones para finales de la década.
MIRA Pharmaceuticals (NASDAQ:MIRA)는 SKNY Pharmaceuticals를 통해 인수 예정인 신약 후보물질 SKNY-1에 대한 유망한 시험관 내 전임상 데이터를 공개했습니다. 이 경구 치료제는 체중 감량 및 금연 시장을 동시에 겨냥하는 이중 수용체 전략을 사용합니다.
SKNY-1은 편향된 CB1 조절제이자 부분 CB2 작용제로 작용하며, 이전의 카나비노이드 기반 치료제들이 정신과적 부작용으로 철회된 문제를 피하도록 설계되었습니다. 이 약물은 β-아레스틴 신호 전달을 선택적으로 차단하면서 G-단백질 신호 전달은 유지하여 기분 장애 없이 체중 감소와 갈망 감소를 가능하게 할 수 있습니다.
또한 이 화합물은 도파민 조절을 위한 약한 MAO-B 억제 효과를 지니고 있어 주사형 GLP-1 약물에 대한 차별화된 대안으로 자리잡고 있습니다. 전 세계 비만 치료제 시장은 2030년까지 1,500억 달러를 초과할 것으로 예상되며, 미국 금연 시장은 2024년 280억 달러에서 2030년 말까지 500억 달러 이상으로 성장할 전망입니다.
MIRA Pharmaceuticals (NASDAQ:MIRA) a dévoilé de nouvelles données précliniques in vitro prometteuses pour SKNY-1, un nouveau candidat médicament en attente d'acquisition via SKNY Pharmaceuticals. Cette thérapie orale cible à la fois les marchés de la perte de poids et de l'arrêt du tabac grâce à une stratégie à double récepteur.
SKNY-1 agit comme un modulateur biaisé du CB1 et un agoniste partiel du CB2, conçu pour éviter les effets secondaires psychiatriques qui ont conduit au retrait des précédentes thérapies à base de cannabinoïdes. Le médicament bloque sélectivement la signalisation β-arrestine tout en préservant la signalisation des protéines G, permettant potentiellement une réduction du poids et une diminution des envies sans perturber l'humeur.
Le composé présente également une inhibition légère de la MAO-B pour la régulation de la dopamine, le positionnant comme une alternative différenciée aux médicaments injectables GLP-1. Le marché mondial des médicaments contre l'obésité devrait dépasser 150 milliards de dollars d'ici 2030, tandis que le marché américain de l'arrêt du tabac devrait passer de 28 milliards de dollars en 2024 à plus de 50 milliards d'ici la fin de la décennie.
MIRA Pharmaceuticals (NASDAQ:MIRA) hat vielversprechende neue in vitro präklinische Daten für SKNY-1 veröffentlicht, einen neuartigen Arzneimittelkandidaten, der durch SKNY Pharmaceuticals übernommen werden soll. Die orale Therapie zielt mit einer Doppelrezeptorstrategie sowohl auf den Markt für Gewichtsverlust als auch für Raucherentwöhnung ab.
SKNY-1 wirkt als selektiver CB1-Modulator und partieller CB2-Agonist, entwickelt, um die psychiatrischen Nebenwirkungen zu vermeiden, die zum Rückzug früherer cannabinoidbasierter Therapien führten. Das Medikament blockiert selektiv die β-Arrestin-Signalgebung und erhält gleichzeitig die G-Protein-Signalgebung, was eine Gewichtsreduktion und verringerte Verlangen ohne Stimmungsschwankungen ermöglichen könnte.
Die Verbindung weist zudem eine milde MAO-B-Hemmung zur Dopaminregulierung auf und positioniert sich damit als differenzierte Alternative zu injizierbaren GLP-1-Medikamenten. Der globale Markt für Adipositasmedikamente wird voraussichtlich bis 2030 150 Milliarden US-Dollar überschreiten, während der US-Markt für Raucherentwöhnung von 28 Milliarden US-Dollar im Jahr 2024 auf über 50 Milliarden bis zum Ende des Jahrzehnts wachsen soll.
- Novel dual-mechanism targeting both obesity and smoking cessation markets
- Designed to avoid psychiatric side effects that affected previous cannabinoid therapies
- Oral administration offers advantage over injectable alternatives
- Targets large market opportunities worth potentially $200B+ combined by 2030
- Multiple complementary mechanisms through CB1 modulation, CB2 agonism, and MAO-B inhibition
- Drug is still in preclinical stage with only in vitro data available
- Acquisition of SKNY Pharmaceuticals still pending regulatory and shareholder approval
- No human clinical trial data available yet to confirm safety and efficacy claims
- Will face competition from established GLP-1 drugs in the weight loss market
Insights
MIRA's acquisition target SKNY-1 shows promising preclinical profile for weight loss/smoking cessation with potentially better safety than past cannabinoid therapies.
MIRA Pharmaceuticals has released new in vitro data for SKNY-1, a drug candidate from SKNY Pharmaceuticals (a company MIRA is in the process of acquiring). The preclinical data presents a differentiated mechanism that could potentially address two massive markets - obesity and smoking cessation.
What makes SKNY-1 scientifically interesting is its selective modulation approach. Previous cannabinoid receptor (CB1) blockers like rimonabant showed efficacy for weight loss but were withdrawn due to serious psychiatric side effects. SKNY-1 attempts to solve this problem through biased signaling - specifically blocking the β-arrestin pathway associated with cravings while preserving G-protein signaling needed for emotional stability.
Additionally, SKNY-1 has a dual-receptor mechanism, acting as a partial CB2 agonist alongside its CB1 modulation. This could potentially enhance metabolic benefits while reducing inflammation. The compound also mildly inhibits MAO-B (but not MAO-A), potentially helping regulate dopamine without serotonin-related side effects.
It's critical to understand that this remains very early-stage data - these are in vitro (laboratory) results only, not human clinical trials. The press release mentions forthcoming animal data, but SKNY-1 would still face years of clinical development before potential approval. The mechanism is scientifically plausible but requires substantial clinical validation.
The dual-market approach targeting both obesity and smoking cessation is strategically sound given their market sizes, but this also raises the complexity bar for successful development. While positioned as an oral alternative to injectable GLP-1s for weight loss, SKNY-1 represents a completely different mechanism with its own unique risk/benefit profile that remains to be fully characterized.
MIRA's pending acquisition brings promising early-stage drug candidate targeting massive weight loss/smoking cessation markets through novel mechanism.
MIRA Pharmaceuticals has revealed strategic rationale behind its planned acquisition of SKNY Pharmaceuticals, centered on SKNY-1, an oral drug candidate targeting the $150+ billion obesity market and $28+ billion smoking cessation market. This represents a significant potential expansion of MIRA's pipeline into high-value therapeutic areas.
The acquisition, which is still pending regulatory review and shareholder approval, would give MIRA access to a compound with a differentiated mechanism from current market leaders. Unlike injectable GLP-1 receptor agonists dominating the obesity space, SKNY-1 works through cannabinoid receptor modulation with a design specifically engineered to avoid the psychiatric side effects that doomed previous attempts in this drug class.
From a market positioning perspective, SKNY-1's potential as an oral therapy represents a clear differentiator against injectable competitors. The company specifically calls out advantages over GLP-1s, noting their association with muscle loss and gastrointestinal side effects. This suggests MIRA is positioning SKNY-1 not necessarily as a more effective weight loss agent but potentially as a better-tolerated alternative with a complementary mechanism.
Investors should note that this remains extremely early-stage - only in vitro data has been generated, with animal studies still in progress. This indicates SKNY-1 is likely years away from potential commercialization, requiring extensive clinical development and regulatory review. The company has not disclosed a timeline for IND filing or clinical trials.
The acquisition itself appears to be a strategic pipeline-building move by MIRA to enter large, commercially attractive markets. However, without financial terms disclosed, it's impossible to assess the value proposition of the deal. The press release indicates MIRA has already submitted SEC filings related to the acquisition, suggesting the transaction is progressing toward completion.
MIAMI, FL / ACCESS Newswire / June 25, 2025 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA) ("MIRA" or the "Company"), a clinical-stage pharmaceutical company focused on developing novel therapeutics for neurologic, neuropsychiatric, and metabolic disorders, today announced new in vitro preclinical data generated by Eurofins supporting the therapeutic potential of SKNY-1, a next-generation oral drug candidate being developed by SKNY Pharmaceuticals, Inc. ("SKNY"). MIRA has signed a definitive agreement to acquire SKNY, and the proposed transaction remains subject to regulatory review and shareholder approval.
SKNY-1 is being developed to help individuals lose weight and quit smoking by targeting key biological pathways involved in appetite, addiction, and reward-without triggering the central nervous system (CNS) side effects that have historically limited cannabinoid-based therapies.
"We believe SKNY-1 could be a first-in-class oral therapy for two of the largest and most underserved markets: obesity and nicotine addiction," said Erez Aminov, CEO of MIRA. "What makes this drug candidate so exciting is its precision-it's engineered to avoid the psychiatric side effects that doomed earlier drugs in this class, while offering a safe, convenient, once-daily oral option."
Designed for Selectivity and Safety
Previous CB1-targeting drugs, such as rimonabant (Acomplia®, Sanofi), showed weight loss and metabolic results but were ultimately withdrawn from the market due to serious psychiatric side effects, including depression and suicidal ideation.¹ These effects stemmed from non-selective inhibition of CB1 signaling in the brain.
In contrast, in vitro studies conducted by Eurofins demonstrated that SKNY-1 acts as a biased CB1 modulator-selectively blocking the β-arrestin signaling pathway, which is associated with cravings and compulsive behavior, while preserving G-protein signaling, which is important for emotional and cognitive stability. This selective mechanism is designed to reduce cravings and body weight without disrupting mood.
A Dual Receptor Strategy-Engaging CB2 for Metabolic Support
In addition to CB1 modulation, SKNY-1 also interacts with the CB2 receptor, which plays a critical role in metabolic regulation and inflammation. Eurofins' in vitro data show that SKNY-1 behaves as a partial CB2 agonist, potentially enhancing fat metabolism, reducing peripheral inflammation and improving insulin sensitivity. This dose-dependent flexibility distinguishes SKNY-1 from earlier CB1-only drugs and may enable a broader therapeutic impact on obesity-related pathways.
"SKNY-1 combines modern pharmacology with real-world practicality," said Dr. Itzchak Angel, Chief Scientific Advisor at MIRA. "By precisely modulating CB1 and CB2 and supporting dopamine stability, it targets obesity and addiction through multiple, complementary mechanisms while potentially avoiding cannabinoid-related psychiatric side-effects."
Dopamine Stability Without Stimulant Risk
SKNY-1 also mildly inhibits the MAO-B enzyme, helping regulate dopamine, a neurotransmitter involved in motivation, focus, and reward. Unlike older monoamine inhibitors, SKNY-1 does not inhibit MAO-A, reducing the risk of serotonin-related side effects. Importantly, the compound demonstrated no or minimal antagonist binding to dopamine receptors (D1, D2, D3), further supporting its favorable CNS safety profile.
A Differentiated Alternative to Injectables
While injectable GLP-1 drugs have gained market attention, they are often associated with gastrointestinal side effects and muscle loss. SKNY-1 is being developed as an oral therapy with a profile and expected mechanism that may help preserve muscle mass and improve patient adherence by avoiding injections.
Market Outlook and Strategic Fit
Obesity and smoking remain two of the world's leading causes of preventable death. The global obesity drug market is projected to surpass
Pending the completion of the proposed acquisition, MIRA believes SKNY-1 could become a cornerstone asset within its pipeline, offering a next-generation solution to two major health challenges. The Company is currently finalizing animal data related to weight loss and nicotine addiction, which will further support its development strategy and future regulatory filings.
MIRA has submitted the required regulatory filings to the U.S. Securities and Exchange Commission (SEC) in connection with the proposed acquisition of SKNY. A shareholder vote will follow in accordance with SEC regulations.
For more information, please visit: www.mirapharmaceuticals.com
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 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.
Footnote:
¹ European Medicines Agency. "Acomplia Suspended as Risks Outweigh Benefits." October 23, 2008.
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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