Skye Bioscience Demonstrates Prominent Role of Peripheral CB1 Inhibition and Achieves Significant Weight Loss with Novel CB1-inhibiting Antibody, Nimacimab, in Preclinical Model
Skye Bioscience (Nasdaq: SKYE) announced preliminary data from a diet-induced obesity (DIO) model study of their CB1-inhibiting antibody, nimacimab. The study demonstrated significant dose-dependent weight loss of up to 16% compared to vehicle control. The experiment used transgenic mice expressing human CB1 receptor, treated with various doses of nimacimab over 35 days. Key findings included dose-dependent weight loss (4.5%, 11.4%, and 16.0%), significant fat mass reduction while preserving lean mass, and improved glucose tolerance. The data suggests peripheral CB1 inhibition drives weight loss without central inhibition's neuropsychiatric risks.
Skye Bioscience (Nasdaq: SKYE) ha annunciato dati preliminari da uno studio modello di obesità indotta da dieta (DIO) sul loro anticorpo inibitore del CB1, nimacimab. Lo studio ha dimostrato una significativa perdita di peso dose-dipendente fino al 16% rispetto al controllo veicolare. L'esperimento ha utilizzato topi transgenici esprimendo il recettore umano CB1, trattati con varie dosi di nimacimab per 35 giorni. I risultati chiave includevano una perdita di peso dose-dipendente (4,5%, 11,4% e 16,0%), una significativa riduzione della massa grassa mantenendo la massa magra e un miglioramento della tolleranza al glucosio. I dati suggeriscono che l'inibizione periferica del CB1 guida la perdita di peso senza i rischi neuropsichiatrici dell'inibizione centrale.
Skye Bioscience (Nasdaq: SKYE) anunció datos preliminares de un estudio modelo de obesidad inducida por dieta (DIO) de su anticuerpo inhibidor de CB1, nimacimab. El estudio mostró una pérdida de peso significativa dependiente de la dosis de hasta 16% en comparación con el control vehicular. El experimento utilizó ratones transgénicos que expresan el receptor humano CB1, tratados con varias dosis de nimacimab durante 35 días. Los hallazgos clave incluyeron pérdida de peso dependiente de la dosis (4.5%, 11.4% y 16.0%), reducción significativa de la masa grasa mientras se preserva la masa magra y mejora en la tolerancia a la glucosa. Los datos sugieren que la inhibición periférica de CB1 impulsa la pérdida de peso sin los riesgos neuropsiquiátricos de la inhibición central.
스카이 바이오사이언스(Skye Bioscience, Nasdaq: SKYE)는 CB1 억제 항체인 nimacimab에 대한 식이 유도 비만(DIO) 모델 연구의 예비 데이터를 발표했습니다. 이 연구는 차량 대조군과 비교하여 최대 16%까지 용량 의존적인 체중 감소를 보여주었습니다. 실험은 인간 CB1 수용체를 발현하는 형질 전환 마우스를 사용하여, 35일 동안 다양한 용량의 nimacimab으로 치료를 진행했습니다. 주요 결과에는 용량 의존적인 체중 감소(4.5%, 11.4% 및 16.0%), 제지방량을 유지하면서 지방량 감소, 그리고 향상된 포도당 내성이 포함되었습니다. 데이터는 말초 CB1 억제가 중앙 억제의 신경정신적 위험 없이 체중 감소를 촉진한다는 것을 제안합니다.
Skye Bioscience (Nasdaq: SKYE) a annoncé des données préliminaires d'une étude modèle d'obésité induite par le régime (DIO) portant sur leur anticorps inhibiteur de CB1, nimacimab. L'étude a démontré une perte de poids significative dépendante de la dose allant jusqu'à 16% par rapport au contrôle véhicule. L'expérience a utilisé des souris transgéniques exprimant le récepteur humain CB1, traitées avec diverses doses de nimacimab pendant 35 jours. Les résultats clés comprenaient une perte de poids dépendante de la dose (4,5%, 11,4% et 16,0%), une réduction significative de la masse grasse tout en préservant la masse maigre, et une amélioration de la tolérance au glucose. Les données suggèrent que l'inhibition périphérique du CB1 favorise la perte de poids sans les risques neuropsychiatriques de l'inhibition centrale.
Skye Bioscience (Nasdaq: SKYE) hat vorläufige Daten aus einer Studie zu einem diätetisch induzierten Adipositasmodell (DIO) zu ihrem CB1-inhibierenden Antikörper, nimacimab, bekannt gegeben. Die Studie zeigte einen signifikanten dosisabhängigen Gewichtsverlust von bis zu 16% im Vergleich zur Fahrzeugkontrolle. Das Experiment nutzte transgene Mäuse, die den menschlichen CB1-Rezeptor exprimieren und über 35 Tage mit verschiedenen Dosen von nimacimab behandelt wurden. Zu den Schlüsselergebnissen gehörten ein dosisabhängiger Gewichtsverlust (4,5%, 11,4% und 16,0%), eine signifikante Reduktion der Fettmasse bei gleichzeitiger Erhaltung der mageren Masse und eine verbesserte Glukosetoleranz. Die Daten deuten darauf hin, dass die periphere CB1-Inhibition den Gewichtsverlust antreibt, ohne die neuropsychiatrischen Risiken der zentralen Inhibition.
- Achieved significant dose-dependent weight loss up to 16% in preclinical trials
- Demonstrated fat mass reduction while preserving lean mass
- Showed dose-dependent improvement in glucose tolerance
- No significant neuropsychiatric adverse events in Phase 1 data
- Results are preliminary and require further validation
- Model still needs refinement according to company statements
Insights
The preclinical data for nimacimab shows remarkable promise in the obesity treatment landscape. The
The study's design using transgenic mice expressing human CB1 receptors strengthens the translational relevance. The dose-dependent response across three treatment groups (7.5, 24 and 75 mg/kg) demonstrates a clear therapeutic window. The concurrent improvement in glucose tolerance suggests potential benefits for diabetes management.
Most notably, this novel antibody approach could offer a safer alternative to existing obesity treatments, potentially complementing GLP-1 agonists. However, investors should note these are early preclinical results that require validation in human trials.
This development positions SKYE strategically in the rapidly growing obesity market, currently dominated by GLP-1 agonists. The unique mechanism of peripheral-only CB1 inhibition could provide a competitive advantage, especially regarding safety profile and potential combination therapy opportunities. With the global obesity market projected to reach
The preliminary data's strength, particularly the dose-dependent response and lean mass preservation, could attract partnership interest from larger pharmaceutical companies. However, the path to commercialization remains long, with significant capital requirements for clinical trials. Investors should consider both the substantial market opportunity and the execution risks inherent in early-stage drug development.
Peripherally-restricted nimacimab achieves significant dose-dependent weight loss, fat mass reduction, lean mass preservation, and glycemic control in diet-induced obesity model
Preliminary data shows that nimacimab achieves desired metabolic outcomes without central inhibition and its risk of neuropsychiatric adverse events
SAN DIEGO, Nov. 04, 2024 (GLOBE NEWSWIRE) -- Skye Bioscience, Inc. (Nasdaq: SKYE) (“Skye”), a clinical-stage biopharmaceutical company focused on unlocking new therapeutic pathways for metabolic health, today announced preliminary data from a diet-induced obesity (DIO) model in mice. Skye’s CB1-inhibiting antibody, nimacimab, achieved significant dose-dependent weight loss of up to
Skye developed a DIO model using a transgenic mouse expressing the human CB1 receptor (hCB1R). After establishing this newly-developed model, the goal of this initial study was to assess the effects of its peripherally-targeting CB1 inhibitor on weight loss and other metabolic parameters. Five groups of mice were treated for 35 days with vehicle, 10 nmol/kg semaglutide, or nimacimab at 7.5 mg/kg, 24 mg/kg or 75 mg/kg, respectively. Key initial findings include:
- Dose-dependent weight loss with nimacimab of
4.5% ,11.4% and16.0% compared to vehicle - Significant fat mass loss with lean mass preservation
- Dose-dependent improvement in glucose tolerance.
Chris Twitty, PhD, Chief Scientific Officer of Skye, commented, “This is the first-ever reported assessment of an antibody-based peripherally-restricted CB1 inhibitor using a DIO model. These results are preliminary and we continue to refine this model, however, the data are very encouraging and provide the first direct evidence supporting our hypothesis that peripheral CB1 inhibition is the primary driver of weight loss whereas central CB1 inhibition contributes minimally to efficacy yet promotes neuropsychiatric adverse events. With this DIO model developed, we are continuing to assess different parameters and look forward to presenting further preclinical data in the future.”
Puneet Arora, MD, Chief Medical Officer of Skye, said, “It is evident from the clinical studies of small molecule CB1 inhibitors that even modest exposure to the brain can cause concerning neuropsychiatric adverse events. We believe that the promising data from these experiments combined with our Phase 1 data, which showed no significant neuropsychiatric adverse events, places nimacimab as the most promising candidate to realize the therapeutic potential of CB1 inhibition. We believe the mechanism of action of nimacimab is complementary to that of incretin mimetics such as GLP-1 receptor agonists. In addition, nimacimab offers the potential of a safe and well-tolerated alternative to the currently approved weight loss drugs.”
Additional data will be presented during ObesityWeek and available as a recorded presentation on the Company’s website under Investor Relations.
About Skye Bioscience
Skye is focused on unlocking new therapeutic pathways for metabolic health through the development of next-generation molecules that modulate G-protein-coupled receptors. Skye's strategy leverages biologic targets with substantial human proof of mechanism for the development of first-in-class therapeutics with clinical and commercial differentiation. Skye is conducting a Phase 2 clinical trial (ClinicalTrials.gov: NCT06577090) in obesity for nimacimab, a negative allosteric modulating antibody that peripherally inhibits CB1. This study is also assessing the combination of nimacimab and a GLP-1R agonist (Wegovy®). For more information, please visit: www.skyebioscience.com. Connect with us on X and LinkedIn.
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FORWARD LOOKING STATEMENTS
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. In some cases, forward-looking statements can be identified by terminology including “anticipated,” “plans,” “goal,” “focus,” “aims,” “intends,” “believes,” “can,” “could,” “challenge,” “predictable,” “will,” “would,” “may” or the negative of these terms or other comparable terminology. These forward looking statements include, but are not limited to: statements regarding our product development, statements regarding the superior safety and tolerability profile of nimacimab relative to other small molecule CB1 inhibitors, statements relating to any expectations regarding the safety, efficacy, tolerability or dosing of nimacimab, including based on Skye’s DIO model, statements regarding the ability of nimacimab to treat obesity or related indications, statements regarding the timing of receipt of interim and final data from Skye’s Phase 2 obesity study of nimacimab, as well as additional preclinical data, and statements regarding the therapeutic potential of antibody-based peripherally-restricted CB1 inhibitors. Such statements and other statements in this press release that are not descriptions of historical facts are forward-looking statements that are based on management’s current expectations and assumptions and are subject to risks and uncertainties. If such risks or uncertainties materialize or such assumptions prove incorrect, our business, operating results, financial condition, and stock price could be materially negatively affected. We operate in a rapidly changing environment, and new risks emerge from time to time. As a result, it is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements the Company may make. Risks and uncertainties that may cause actual results to differ materially include, among others, our capital resources, uncertainty regarding the results of future testing and development efforts and other risks that are described in the Company’s periodic filings with the Securities and Exchange Commission, including in the “Risk Factors” section of Skye’s most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q. Except as expressly required by law, Skye disclaims any intent or obligation to update these forward-looking statements.
FAQ
What were the weight loss results for Skye Bioscience's nimacimab in the DIO model?
How long was the treatment period in Skye Bioscience's nimacimab DIO study?
What are the key advantages of SKYE's nimacimab over other CB1 inhibitors?
What doses of nimacimab were tested in SKYE's DIO study?
