Skye Bioscience Surpasses 50% Patient Enrollment in Phase 2 Obesity Study of Differentiated CB1 Inhibitor
Skye Bioscience has reached over 50% enrollment in its CBeyond™ Phase 2 clinical trial evaluating nimacimab, a CB1 inhibitor for obesity treatment. The study aims to enroll 120 patients across four treatment groups, with interim data expected in Q2 2025. The trial's primary endpoint will measure weight loss compared to placebo, with an exploratory endpoint assessing nimacimab combined with Wegovy®. Nimacimab is highlighted as the most peripherally restricted CB1 inhibitor, showing promising preclinical results with minimal brain accumulation and no neuropsychiatric adverse events in Phase 1 studies.
Skye Bioscience ha raggiunto oltre il 50% di arruolamento nel trial clinico di fase 2 CBeyond™ che valuta nimacimab, un inibitore del CB1 per il trattamento dell'obesità. Lo studio mira ad arruolare 120 pazienti suddivisi in quattro gruppi di trattamento, con dati interim attesi nel secondo trimestre del 2025. L'obiettivo primario del trial misurerà la perdita di peso rispetto al placebo, con un obiettivo esplorativo che valuterà nimacimab combinato con Wegovy®. Nimacimab è evidenziato come il più restrittivo inibitore del CB1 a livello periferico, mostrando risultati preclinici promettenti con minima accumulazione nel cervello e senza eventi avversi neuropsichiatrici negli studi di fase 1.
Skye Bioscience ha alcanzado más del 50% de inscripción en su ensayo clínico de fase 2 CBeyond™ que evalúa nimacimab, un inhibidor de CB1 para el tratamiento de la obesidad. El estudio tiene como objetivo inscribir a 120 pacientes en cuatro grupos de tratamiento, con datos intermedios esperados para el segundo trimestre de 2025. El objetivo primario del ensayo medirá la pérdida de peso en comparación con un placebo, mientras que un objetivo exploratorio evaluará nimacimab combinado con Wegovy®. Nimacimab se destaca como el inhibidor de CB1 más restringido periféricamente, mostrando resultados preclínicos prometedores con acumulación cerebral mínima y sin eventos adversos neuropsiquiátricos en estudios de fase 1.
Skye Bioscience는 비만 치료를 위한 CB1 억제제인 nimacimab에 대한 CBeyond™ 2상 임상 시험에서 50% 이상의 등록률을 달성했습니다. 이 연구는 4개의 치료 그룹에 걸쳐 120명의 환자를 등록하는 것을 목표로 하며, 중간 데이터는 2025년 2분기에 예상됩니다. 시험의 주요 목표는 플라세보와 비교한 체중 감소를 측정하며, 탐색적 목표는 Wegovy®와 병합된 nimacimab을 평가합니다. Nimacimab는 가장 말초적으로 제한된 CB1 억제제로, 1상 연구에서 최소한의 뇌 축적과 신경정신과적 부작용 없이 유망한 전임상 결과를 보여주고 있습니다.
Skye Bioscience a atteint plus de 50% d'inscription dans son essai clinique de phase 2 CBeyond™ évaluant nimacimab, un inhibiteur de CB1 pour le traitement de l'obésité. L'étude vise à recruter 120 patients répartis en quatre groupes de traitement, avec des données intermédiaires attendues au deuxième trimestre de 2025. L'objectif principal de l'essai mesurera la perte de poids par rapport au placebo, avec un objectif exploratoire évaluant nimacimab en combinaison avec Wegovy®. Nimacimab est mis en avant comme l'inhibiteur de CB1 le plus strictement périphérique, montrant des résultats précliniques prometteurs avec une accumulation cérébrale minimale et aucun événement indésirable neuropsychiatrique lors des études de phase 1.
Skye Bioscience hat über 50% der Einschreibung in die klinische Phase-2-Studie CBeyond™ zur Bewertung von nimacimab, einem CB1-Inhibitor zur Behandlung von Fettleibigkeit, erreicht. Die Studie zielt darauf ab, 120 Patienten in vier Behandlungsgruppen zu rekrutieren, wobei interimistische Daten im 2. Quartal 2025 erwartet werden. Das primäre Ziel der Studie wird den Gewichtsverlust im Vergleich zu Placebo messen, während ein exploratives Ziel nimacimab in Kombination mit Wegovy® bewerten wird. Nimacimab wird als der am wenigsten peripher restriktive CB1-Inhibitor hervorgehoben und zeigt vielversprechende präklinische Ergebnisse mit minimaler Akkumulation im Gehirn und ohne neuropsychiatrische Nebenwirkungen in Phase-1-Studien.
- Achieved 50% enrollment milestone in Phase 2 obesity trial
- Strong enrollment pace may accelerate timeline to topline data
- Demonstrated favorable gastrointestinal tolerability compared to GLP-1 agonists
- Showed positive preclinical results in diet-induced obesity model
- No neuropsychiatric adverse events observed in Phase 1 trials
- Results from Phase 2 trial not expected until Q2 2025
- Still requires completion of enrollment for remaining 50% of patients
Insights
The 50% enrollment milestone in Skye's Phase 2 obesity trial represents significant progress for their CB1 inhibitor nimacimab. The trial's design, targeting 120 patients across four treatment groups, is particularly noteworthy for including a combination arm with Wegovy®, the current market leader in obesity treatment.
The differentiation of nimacimab as a peripherally-restricted monoclonal antibody is important - preliminary data suggests it achieves weight loss without crossing the blood-brain barrier, potentially offering a superior safety profile compared to small-molecule CB1 inhibitors. The lack of neuropsychiatric adverse events in Phase 1 and better GI tolerability versus GLP-1 agonists could position nimacimab as a compelling alternative in the rapidly growing obesity market.
The comprehensive endpoint analysis, including DEXA scans for body composition and metabolic parameters, will provide valuable insights into nimacimab's efficacy profile by Q2 2025. The accelerated enrollment pace suggests potential earlier topline data readout.
SAN DIEGO, Nov. 14, 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 that it has achieved more than
“We are grateful for the amazing motivation and responsiveness shown by our study participants and clinical investigators in the assessment of this first-in-class drug candidate for weight loss. The current pace of patient enrollment may also shorten our timeline to topline data next year. We will provide a further update after reaching full enrollment,” said Puneet Arora, MD, Skye’s Chief Medical Officer. “This is a rigorous clinical trial evaluating multiple important parameters. We look forward to advancing nimacimab through this program and getting this Phase 2 data next year.”
“CB1 inhibition has been shown in preclinical and clinical studies to have attributes with the potential to play a distinct role in achieving the goal of healthier, more sustainable anti-obesity drug regimens,” said Punit Dhillon, President & Chief Executive Officer. “Within the class, our monoclonal antibody, nimacimab, is the most peripherally restricted CB1 inhibitor, even compared to the most peripherally restricted small molecules. Importantly, our recently announced preclinical diet-induced obesity model data provides evidence for sufficiency of CB1 inhibition outside the brain to drive meaningful weight loss. We believe the effects of nimacimab in the periphery cause metabolic gains and directly cause fat loss, while modulating hunger and increasing satiety without the need to inhibit CB1 receptors in the brain.
Mr. Dhillon added: “With virtually undetectable accumulation in the brain, we believe nimacimab has the best safety profile among CB1 inhibitors. In Phase 1 and preclinical studies of nimacimab, there were no observations of neuropsychiatric adverse events, a risk and outcome that plagues small-molecule CB1 inhibitors with their to-date unavoidable engagement with CB1 in the brain. Notably, nimacimab’s gastrointestinal tolerability far exceeds GLP-1 receptor agonists, and CB1 inhibition has displayed favorable outcomes with respect to lean mass preservation. With these attributes, we believe nimacimab is well-positioned to play a breakthrough role in realizing the therapeutic benefits of CB1 inhibition as an important non-incretin alternative.”
CBeyond™ Phase 2 Clinical Trial Design
This clinical trial is a randomized, double-blind study designed to enroll 120 patients across four treatment groups. The primary endpoint will evaluate the difference in weight loss of nimacimab compared to placebo. An exploratory endpoint will assess a combination of nimacimab and Wegovy® compared to placebo and Wegovy®.
Secondary and other exploratory endpoints will assess safety and tolerability; neuropsychiatric and cognitive outcomes; change in body composition by dual-energy X-ray absorptiometry (DEXA); metabolic parameters; and improvement in sleep.
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, including lack of neuropsychiatric effects, efficacy, tolerability or dosing of nimacimab, including based on preclinical models and the clinical information from the nimacimab Phase 1 study in NAFLD, 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 and statements regarding the therapeutic potential of nimacimab. 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 is the current enrollment status of Skye Bioscience's Phase 2 obesity trial?
When will Skye Bioscience report interim data for the CBeyond™ Phase 2 trial?
How many patients will be enrolled in Skye Bioscience's Phase 2 obesity trial?
What are the key advantages of nimacimab compared to other CB1 inhibitors?
