Skye Completes 26-week Treatment Phase in Phase 2a CBeyond鈩⒙燬tudy
Skye Bioscience (Nasdaq: SKYE) has announced the completion of the 26-week treatment phase in its Phase 2a CBeyond鈩� 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庐).
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鈩� che valuta nimacimab, un anticorpo inibitore periferico del recettore CB1 per il trattamento dell'obesit脿. L'endpoint primario valuta la variazione di peso tra nimacimab e placebo, con un braccio esplorativo che studia la combinazione con semaglutide (Wegovy庐).
La societ脿 ha inoltre concluso il reclutamento per uno studio di estensione di 26 settimane, che fornir脿 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 finalizaci贸n de la fase de tratamiento de 26 semanas en su ensayo cl铆nico de fase 2a CBeyond鈩� que eval煤a nimacimab, un anticuerpo inhibidor perif茅rico del receptor CB1 para el tratamiento de la obesidad. El objetivo primario del estudio evaluar谩 los cambios de peso entre nimacimab y placebo, con un brazo exploratorio que analiza la combinaci贸n con semaglutida (Wegovy庐).
La compa帽铆a tambi茅n complet贸 el reclutamiento para un estudio de extensi贸n de 26 semanas, que aportar谩 datos para una duraci贸n 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 extensi贸n se anticipan en el primer trimestre de 2026.
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須岇偓電� 霕愴暅 鞝勳泊 旃橂 旮瓣皠鞚� 52欤茧 頃橂姅 雿办澊韯半ゼ 鞝滉车頃� 26欤� 鞐办灔 鞐瓣惮鞚� 霌彪鞚� 鞕勲頄堨溂氅�, 鞚错泟 13欤� 於旍爜 甏�彀办澊 歆勴枆霅╇媹雼�. 齑堦赴 雼硠鞚� topline 雿办澊韯半姅 2025雲� 3攵勱赴 毵�/4攵勱赴 齑�鞐� 鞓堨儊霅橂┌, 鞐办灔 鞐瓣惮 瓴瓣臣電� 2026雲� 1攵勱赴鞐� 鞓堨儊霅╇媹雼�.
Skye Bioscience (Nasdaq: SKYE) a annonc茅 l'ach猫vement de la phase de traitement de 26 semaines de son essai clinique de phase 2a CBeyond鈩� 茅valuant nimacimab, un anticorps inhibiteur p茅riph茅rique du r茅cepteur CB1 pour le traitement de l'ob茅sit茅. Le crit猫re principal 茅tudiera la variation de poids entre nimacimab et placebo, avec un bras exploratoire examinant la combinaison avec semaglutide (Wegovy庐).
La soci茅t茅 a 茅galement boucl茅 le recrutement pour une 茅tude d'extension de 26 semaines, qui fournira des donn茅es pour une dur茅e totale de traitement de 52 semaines, suivie d'une p茅riode de suivi de 13 semaines. Les donn茅es principales de la phase initiale sont attendues 脿 la fin du T3/d茅but du T4 2025, tandis que les r茅sultats de l'茅tude d'extension sont pr茅vus au T1 2026.
Skye Bioscience (Nasdaq: SKYE) hat den Abschluss der 26-w枚chigen Behandlungsphase in der Phase-2a-Studie CBeyond鈩� bekanntgegeben, in der nimacimab, ein peripher wirkender CB1-Inhibitor-Antik枚rper zur Behandlung von Adipositas, untersucht wird. Der prim盲re Endpunkt bewertet die Gewichtsver盲nderungen zwischen nimacimab und Placebo; ein explorativer Arm pr眉ft die Kombination mit Semaglutid (Wegovy庐).
Das Unternehmen hat au脽erdem die Einschreibung f眉r eine 26-w枚chige Verl盲ngerungsstudie abgeschlossen, die Daten f眉r eine gesamte Behandlungsdauer von 52 Wochen liefern wird, gefolgt von einer 13-w枚chigen Nachbeobachtung. Topline-Daten der Anfangsphase werden f眉r Ende Q3/Anfang Q4 2025 erwartet, die Ergebnisse der Verl盲ngerungsstudie werden f眉r 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庐). 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 鈥� 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 鈥� 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鈥憌eek extension study; 52鈥憌eek data planned, with post鈥慹xtension 13鈥憌eek follow鈥憉p
SAN DIEGO, Sept. 02, 2025 (GLOBE NEWSWIRE) -- Skye Bioscience, Inc. (Nasdaq: SKYE) (鈥淪kye鈥�), 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鈩⒙燾linical trial evaluating nimacimab, Skye鈥檚 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鈩⒙燩hase 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庐) and nimacimab versus semaglutide (Wegovy庐) and placebo. A complete description of this study can be found in Skye鈥檚 nimacimab Phase 2a study initiation .
鈥淲e launched CBeyond鈩�, 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,鈥� said Puneet Arora, MD, MS, FACE, Chief Medical Officer of Skye. 鈥淲e 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.
鈥淭here is growing recognition that GLP-1 weight loss drugs cannot meet all patients鈥� needs and for many patients induce tolerability issues that compromise or preclude long-term benefit. We don鈥檛 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.鈥�
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庐), 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庐). 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 () 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庐). For more information, please visit: . Connect with us on and .
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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 鈥渁nticipated,鈥� 鈥減lans,鈥� 鈥済oal,鈥� 鈥渇ocus,鈥� 鈥渁ims,鈥� 鈥渋ntends,鈥� 鈥渂elieves,鈥� 鈥渃an,鈥� 鈥渃ould,鈥� 鈥渃hallenge,鈥� 鈥減redictable,鈥� 鈥渨ill,鈥� 鈥渨ould,鈥� 鈥渕ay鈥� 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鈥檚 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鈥檚 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鈥檚 periodic filings with the Securities and Exchange Commission, including in the 鈥淩isk Factors鈥� section of Skye鈥檚 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?
