Skye Completes 26-week Treatment Phase in Phase 2a CBeyond™ Study
Skye Bioscience (Nasdaq: SKYE) has announced the completion of the 26-week treatment phase in its Phase 2a CBeyond™ clinical trial evaluating nimacimab, a peripherally-restricted CB1 inhibitor antibody for obesity treatment. The study's primary endpoint will assess weight loss changes between nimacimab and placebo, with an exploratory arm examining the combination with semaglutide (Wegovy®).
The company has also completed enrollment for a 26-week extension study, which will provide data for a total treatment duration of 52 weeks, followed by a 13-week follow-up period. Topline data from the initial phase is expected in late Q3/early Q4 2025, while extension study results are anticipated in Q1 2026.
Skye Bioscience (Nasdaq: SKYE) ha comunicato di aver completato la fase di trattamento di 26 settimane nello studio clinico di Fase 2a CBeyond™ che valuta nimacimab, un anticorpo inibitore periferico del recettore CB1 per il trattamento dell'obesità. L'endpoint primario valuta la variazione di peso tra nimacimab e placebo, con un braccio esplorativo che studia la combinazione con semaglutide (Wegovy®).
La società ha inoltre concluso il reclutamento per uno studio di estensione di 26 settimane, che fornirà dati su un trattamento complessivo di 52 settimane, seguito da un periodo di follow-up di 13 settimane. I dati principali della fase iniziale sono attesi nella fine del terzo trimestre/inizio del quarto trimestre 2025, mentre i risultati dello studio di estensione sono previsti nel primo trimestre 2026.
Skye Bioscience (Nasdaq: SKYE) ha anunciado la finalización de la fase de tratamiento de 26 semanas en su ensayo clínico de fase 2a CBeyond™ que evalúa nimacimab, un anticuerpo inhibidor periférico del receptor CB1 para el tratamiento de la obesidad. El objetivo primario del estudio evaluará los cambios de peso entre nimacimab y placebo, con un brazo exploratorio que analiza la combinación con semaglutida (Wegovy®).
La compañía también completó el reclutamiento para un estudio de extensión de 26 semanas, que aportará datos para una duración total de tratamiento de 52 semanas, seguido de un periodo de seguimiento de 13 semanas. Se esperan los datos principales de la fase inicial a finales del tercer trimestre/principios del cuarto trimestre de 2025, mientras que los resultados del estudio de extensión se anticipan en el primer trimestre de 2026.
Skye Bioscience (Nasdaq: SKYE)는 비만 치료용 말초 제한형 CB1 억제 항체인 nimacimab을 평가하는 2상(a) 임상시험 CBeyond™의 26주 치료 단계를 완료했다고 발표했습니다. 연구의 주요 평가변수는 nimacimab과 위약 간 체중 변화이며, 탐색적 군에서는 세마글루타이드(Wegovy®)와의 병용을 조사합니다.
회사는 또한 전체 치료 기간을 52주로 하는 데이터를 제공할 26주 연장 연구의 등록을 완료했으며, 이후 13주 추적 관찰이 진행됩니다. 초기 단계의 topline 데이터는 2025년 3분기 말/4분기 초에 예상되며, 연장 연구 결과는 2026년 1분기에 예상됩니다.
Skye Bioscience (Nasdaq: SKYE) a annoncé l'achèvement de la phase de traitement de 26 semaines de son essai clinique de phase 2a CBeyond™ évaluant nimacimab, un anticorps inhibiteur périphérique du récepteur CB1 pour le traitement de l'obésité. Le critère principal étudiera la variation de poids entre nimacimab et placebo, avec un bras exploratoire examinant la combinaison avec semaglutide (Wegovy®).
La société a également bouclé le recrutement pour une étude d'extension de 26 semaines, qui fournira des données pour une durée totale de traitement de 52 semaines, suivie d'une période de suivi de 13 semaines. Les données principales de la phase initiale sont attendues à la fin du T3/début du T4 2025, tandis que les résultats de l'étude d'extension sont prévus au T1 2026.
Skye Bioscience (Nasdaq: SKYE) hat den Abschluss der 26-wöchigen Behandlungsphase in der Phase-2a-Studie CBeyond™ bekanntgegeben, in der nimacimab, ein peripher wirkender CB1-Inhibitor-Antikörper zur Behandlung von Adipositas, untersucht wird. Der primäre Endpunkt bewertet die Gewichtsveränderungen zwischen nimacimab und Placebo; ein explorativer Arm prüft die Kombination mit Semaglutid (Wegovy®).
Das Unternehmen hat außerdem die Einschreibung für eine 26-wöchige Verlängerungsstudie abgeschlossen, die Daten für eine gesamte Behandlungsdauer von 52 Wochen liefern wird, gefolgt von einer 13-wöchigen Nachbeobachtung. Topline-Daten der Anfangsphase werden für Ende Q3/Anfang Q4 2025 erwartet, die Ergebnisse der Verlängerungsstudie werden für Q1 2026 prognostiziert.
- Study achieved important milestone with completion of 26-week treatment phase
- Successfully enrolled patients for 26-week extension study, enabling longer-term efficacy data
- Novel mechanism of action could potentially address limitations of existing GLP-1 weight loss drugs
- Study includes both monotherapy and combination therapy with Wegovy, expanding potential applications
- No efficacy data available yet from the clinical trial
- Results not expected until late Q3/early Q4 2025
- Extension study results won't be available until Q1 2026
Insights
Skye's CB1 inhibitor obesity drug completes primary treatment phase with topline data imminent; provides valuable alternative mechanism to GLP-1s.
Skye has reached a critical milestone in its clinical development program with the completion of the 26-week treatment phase for its Phase 2a obesity trial. This development keeps the company on track to report topline data in late Q3/early Q4 2025, maintaining the timeline established when the trial was initiated 12 months ago.
The study design deserves particular attention. This trial is evaluating nimacimab, a peripherally-restricted CB1 inhibitor antibody, in both monotherapy and combination settings with semaglutide (Wegovy®). This dual-approach strategy is especially shrewd as it positions nimacimab as both a potential standalone therapy and as a complementary treatment to enhance GLP-1 outcomes, significantly expanding its market potential.
What makes this program particularly intriguing is its mechanism of action. CB1 inhibition has substantial historical efficacy data for weight loss, but previous central-acting inhibitors like rimonabant were discontinued due to psychiatric side effects. Skye's peripherally-restricted approach aims to retain efficacy while eliminating these central nervous system issues – a potential breakthrough if successful.
The company has also demonstrated impressive operational execution by simultaneously completing enrollment for the 26-week extension study. This will provide 52-week efficacy data followed by a 13-week follow-up period, offering crucial insights into durability of effect and rebound phenomena after treatment cessation – key considerations for obesity therapeutics that are often overlooked in shorter trials.
With results expected in late 2025 and extension data in Q1 2026, Skye is positioning nimacimab as a potential alternative in the rapidly expanding obesity market, particularly for patients experiencing tolerability issues with GLP-1 therapies.
Skye also announces completion of enrollment of 26‑week extension study; 52‑week data planned, with post‑extension 13‑week follow‑up
SAN DIEGO, Sept. 02, 2025 (GLOBE NEWSWIRE) -- Skye Bioscience, Inc. (Nasdaq: SKYE) (“Skye”), a clinical-stage biotechnology company focused on unlocking new therapeutic pathways for obesity and other metabolic health disorders, today announced that the last patient has completed 26 weeks of treatment in the main study of its Phase 2a CBeyond™ clinical trial evaluating nimacimab, Skye’s peripherally-restricted CB1 inhibitor antibody, for the treatment of obesity and overweight. Skye expects to report topline data from the trial in late Q3/early Q4 of 2025.
The CBeyond™ Phase 2a trial is a randomized, double-blind, placebo-controlled study designed to assess weight loss, safety, tolerability, and other metabolic biomarkers in adults with obesity and overweight. The primary endpoint will compare change in weight from baseline to 26 weeks between nimacimab and placebo. An exploratory arm is assessing the combination of semaglutide (Wegovy®) and nimacimab versus semaglutide (Wegovy®) and placebo. A complete description of this study can be found in Skye’s nimacimab Phase 2a study initiation news release.
“We launched CBeyond™, this proof-of-concept Phase 2a trial of nimacimab, 12 months ago and are pleased that the final patient has completed treatment for the 26-week primary endpoint,” said Puneet Arora, MD, MS, FACE, Chief Medical Officer of Skye. “We thank all the patients who participated in the trial, and our investigators, coordinators and partners, whose commitment enabled the rapid conduct to date of this important study.
“There is growing recognition that GLP-1 weight loss drugs cannot meet all patients’ needs and for many patients induce tolerability issues that compromise or preclude long-term benefit. We don’t believe there is an alternative new mechanism with as much clinical and preclinical evidence of potential to help address these shortcomings as CB1 inhibition and, pertinently, peripheral CB1 inhibition driven by an antibody. We look forward to reporting topline clinical results of this first planned leg of our Phase 2a study and also continuing with the previously announced 26-week extension as we advance our assessment of nimacimab as a potential new therapeutic option for obesity and overweight.”
Completion of enrollment of Phase 2a study extension
Skye has also completed enrollment of the 26-week extension of the Phase 2a trial that it announced in July 2025. This extension is designed to obtain data from 52 weeks of treatment using nimacimab as monotherapy or in combination with semaglutide (Wegovy®), offering longer-term insight into weight loss driven by a peripheral CB1 inhibitor antibody. Patients who continued to be enrolled in the study and completed 26 weeks of treatment in the primary arm of the study were eligible to enroll in the 26-week extension for a potential full treatment duration of 52 weeks followed by a 12-week follow-up period. Patients in the monotherapy arm will receive open label nimacimab during the extension. In the combination arms, patients will continue with blinded treatment with nimacimab or placebo and will continue receiving semaglutide (Wegovy®). Skye expects to report data from the extension study in Q1 2026.
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 2a 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: (i) statements relating to any expectations regarding the efficacy and therapeutic potential of nimacimab as a monotherapy or in combination with a GLP-1 targeted drug, (ii) statements regarding the potential of CB1 inhibition to address certain unmet needs of patients on GLP-1 weight loss drugs and (iii) statements regarding the timing of receipt of data from Skye’s Phase 2a obesity study, including its extension study. 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 that could cause our actual results to differ materially from those expressed or implied by such forward-looking statements. 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. 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 is the primary endpoint of Skye's Phase 2a CBeyond clinical trial?
When will Skye Bioscience (SKYE) report topline data from the CBeyond trial?
How long is the total treatment duration in Skye's CBeyond clinical trial including the extension?
How does Skye's nimacimab differ from existing obesity treatments?
What is being tested in the combination arm of Skye's Phase 2a trial?
