Skye Presents Phase 1b Data for its Peripheral CB1-inhibiting Antibody, Nimacimab, at European Association for the Study of Diabetes (EASD) Annual Meeting
Skye Bioscience (NASDAQ:SKYE) presented Phase 1b study results for nimacimab, their peripheral CB1-inhibiting antibody, at the EASD Annual Meeting. The study, conducted in subjects with metabolic-associated steatotic liver disease (MASLD), demonstrated favorable safety and tolerability profiles.
Key findings include no serious adverse events, no discontinuations due to adverse events, and notably, no neuropsychiatric safety signals. The drug showed predictable pharmacokinetics, low immunogenicity, and only mild, infrequent gastrointestinal side effects across multiple ascending dose cohorts.
The study, originally conducted by Bird Rock Bio (acquired by Skye in 2023), supports nimacimab's potential role in treating metabolic diseases, with the company awaiting topline results from their CBeyond™ Phase 2a obesity study.
Skye Bioscience (NASDAQ:SKYE) ha presentato i risultati dello studio di Fase 1b per nimacimab, il loro anticorpo inibitore periferico CB1, al Congresso Annuale EASD. Lo studio, condotto su soggetti con malattia metabolica associata alla steatosi epatica (MASLD), ha mostrato profili di sicurezza e tollerabilità favorevoli.
Tra i principali riscontri: nessun evento avverso grave, nessuna interruzione a causa di eventi avversi e, soprattutto, nessun segnale di sicurezza neuropsichiatrico. Il farmaco ha mostrato farmacocinetica prevedibile, bassa immunogenicità e solo lievi, rari effetti gastrointestinali in diverse coorti a dose crescente.
Lo studio, originariamente condotto da Bird Rock Bio (acquisita da Skye nel 2023), supporta il ruolo potenziale di nimacimab nel trattamento di malattie metaboliche, con l’azienda in attesa dei risultati principali dal loro studio CBeyond™ di Fase 2a sull’obesità.
Skye Bioscience (NASDAQ:SKYE) presentó los resultados del estudio de Fase 1b para nimacimab, su anticuerpo inhibidor periférico de CB1, en la Reunión Anual de la EASD. El estudio, realizado en sujetos con enfermedad hepática grasa metabólica asociada (MASLD), mostró perfiles de seguridad y tolerabilidad favorables.
Entre los hallazgos clave se destacan ningún evento adverso grave, ninguna discontinuación debido a eventos adversos y, notablemente, ninguna señal de seguridad neuropsiquiátrica. El fármaco mostró farmacocinética predecible, baja inmunogenicidad y solo efectos gastrointestinales leves y poco frecuentes en múltiples cohortes de dosis crecientes.
El estudio, originalmente realizado por Bird Rock Bio (adquirida por Skye en 2023), respalda el posible papel de nimacimab en el tratamiento de enfermedades metabólicas, con la empresa a la espera de los resultados preliminares de su estudio CBeyond™ Fase 2a sobre obesidad.
Skye Bioscience(NASDAQ:SKYE)가 nimacimab의 1b상 연구 결과를 EASD 연례 학회에서 발표했습니다. 말초 CB1 차단 항체인 nimacimab은 대사성 지방간 질환(MASLD)을 가진 대상자들을 대상으로 수행된 이 연구에서 안전성과 내약성이 우수함을 보였습니다.
주요 발견으로는 중대한 이상반응 없음, 이상반응으로 인한 중단 없음, 그리고 특히 신경정신학적 안전성 신호 없음이 포함됩니다. 약물은 예측 가능한 약동학, 낮은 면역원성, 여러 상승 용량 코호트에서 경증의 드물게 보고된 위장관 부작용만을 보였습니다.
Bird Rock Bio(2023년 Skye가 인수)에서 원래 수행되었던 이 연구는 대사 질환 치료에서 nimacimab의 잠재적 역할을 뒷받침하며, 회사는 CBeyond™ 2상 1a 비만 연구의 topline 결과를 기다리고 있습니다.
Skye Bioscience (NASDAQ:SKYE) a présenté les résultats de l’étude de phase 1b pour nimacimab, leur anticorps inhibiteur périphérique CB1, lors de la réunion annuelle de l’EASD. L’étude, réalisée chez des sujets atteints de maladie hépatique gras liée à des dérèglements métaboliques (MASLD), a démontré des profils de sécurité et de tolérance favorables.
Parmi les résultats clés, aucun événement indésirable grave, aucune discontinuation pour événement indésirable et, surtout, aucun signal de sécurité neuropsychiatrique. Le médicament a montré une pharmacocinétique prévisible, une faible immunogénicité et seulement des effets indésirables gastro-intestinaux légers et peu fréquents sur plusieurs cohortes de doses croissantes.
L’étude, initialement menée par Bird Rock Bio (acquise par Skye en 2023), soutient le rôle potentiel de nimacimab dans le traitement des maladies métaboliques, l’entreprise attendant les résultats préliminaires de leur étude CBeyond™ Phase 2a sur l’obésité.
Skye Bioscience (NASDAQ:SKYE) präsentierte die Ergebnisse der Phase-1b-Studie zu nimacimab, ihrem peripheren CB1-Inhibitor-Antikörper, auf der EASD-Jahrestagung. Die Studie wurde bei Probanden mit metabolisch bedingter Steatose der Leber (MASLD) durchgeführt und zeigte ein vorteilhaftes Sicherheits- und Verträglichkeitsprofil.
Zu den wichtigsten Erkenntnissen gehören keine schweren unerwünschten Ereignisse, keine Abbruch gründen durch unerwünschte Ereignisse und vor allem kein neuropsychiatrisches Sicherheitssignal. Das Medikament zeigte eine vorhersagbare Pharmakokinetik, geringe Immunogenität und lediglich milde, seltene gastrointestinale Nebenwirkungen in mehreren Dosissteigerungskohorten.
Die Studie, ursprünglich von Bird Rock Bio durchgeführt (im Jahr 2023 von Skye übernommen), unterstützt die potenzielle Rolle von nimacimab bei der Behandlung metabolischer Krankheiten, und das Unternehmen erwartet die Topline-Ergebnisse aus ihrer CBeyond™ Phase-2a-Studie zu Fettleibigkeit.
Skye Bioscience (NASDAQ:SKYE) قدمت نتائج دراسة المرحلة 1b لـ nimacimab، جسم مضاد CB1 محيطي، في الاجتماع السنوي EASD. الدراسة التي أُجريت على أشخاص مصابين بمرض دهون كبد متصل بالميتابوليزم (MASLD) أظهرت ملفات أمان وتحمل إيجابية.
تشمل النتائج الرئيسية عدم وجود أحداث عكسية خطيرة، وعدم الإيقاف بسبب أحداث عكسية، ولفت الانتباه إلى عدم وجود إشارات أمان عصبية-نفسية. أظهر الدواء حركية دوائية قابلة للتوقع، ومناعة منخفضة، وتأثيرات جانبية هضمية خفيفة ونادرة عبر عدة مجموعات جر متفاوتة.
الدراسة، التي أجرتها Bird Rock Bio أصلاً (التي استحوذت عليها Skye في 2023)، تدعم الدور المحتمل لـ Nimacimab في علاج الأمراض الأيضية، مع انتظار الشركة لنتائج الكلمة الأولى من دراسة CBeyond™ Phase 2a للبدانة.
Skye Bioscience (纳斯达克股票代码：SKYE) 在 EASD 年会公布了 nimacimab 的 1b 期研究结果，这是他们的周边 CB1 抑制抗体。该研究在代谢相关脂肪肝病（MASLD）患者中进行，显示出有利的安全性和耐受性概况。
主要发现包括 无严重不良事件、无因不良事件导致的中止，且尤其是 无神经精神安全信号。药物展现出可预测的药代动力学、低免疫原性，以及在多组递增剂量中仅有轻微、罕见的胃肠道副作用。
该研究最初由 Bird Rock Bio 进行（于 2023 年被 Skye 收购），支持 nimacimab 在治疗代谢性疾病中的潜在作用，公司正在等待 CBeyond™ 第 2a 期肥胖研究的 topline 结果。
- Demonstrated favorable safety profile with no serious adverse events
- No neuropsychiatric safety signals observed
- Showed predictable pharmacokinetics and low immunogenicity
- Minimal gastrointestinal side effects reported
- Successfully completed Phase 1b study in MASLD patients
- Early-stage clinical data (Phase 1b) - still requires further clinical validation
- Limited scope of study focusing only on safety and tolerability, not efficacy
Novel CB1 inhibitor Phase 1b data highlights lack of neuropsychiatric adverse events and favorable gastrointestinal tolerability
SAN DIEGO, Sept. 19, 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 the presentation of results from the Phase 1b study of nimacimab in subjects with metabolic-associated steatotic liver disease (MASLD) at the European Association for the Study of Diabetes (EASD) Annual Meeting.
The study demonstrated that nimacimab was safe, well-tolerated, and exhibited predictable pharmacokinetics and low immunogenicity across multiple ascending dose cohorts. Importantly, there were no serious adverse events, no discontinuations due to adverse events, and no evidence of neuropsychiatric safety signals. Gastrointestinal side effects were infrequent and mild, underscoring the potential differentiated tolerability profile of this peripheral CB1-inhibiting antibody.
“These Phase 1b results provide an early glimpse of the benchmark safety and tolerability profile that we believe sets nimacimab apart within the broader anti-obesity medicine landscape,” said Puneet Arora, MD, MS, FACE, Chief Medical Officer of Skye Bioscience. “Obesity is a multi-factorial disease with overlapping pathways across key organs including the liver, adipose tissue, and muscle. While our immediate focus is on the upcoming topline readout from our CBeyond™ Phase 2a obesity study, these favorable findings in an obese, diabetic MASLD population help establish nimacimab’s potential role in the treatment of metabolic diseases.”
This Phase 1b study was previously conducted by Bird Rock Bio, Inc., which Skye acquired in 2023.
The presentation, made in the oral category session called “New medications on the horizon?”, was titled “A multiple dose study to evaluate the safety and tolerability of nimacimab, a peripherally restricted, inhibitory CB1 receptor antibody in subjects with metabolic associated fatty liver disease (MAFLD).” The slides are available on Skye’s website on the Spotlight page.
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,” “potential” or the negative of these terms or other comparable terminology. These forward looking statements include, but are not limited to: 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 or other incretin drugs, statements regarding the potential of CB1 inhibition to address certain unmet needs of patients on GLP-1 weight loss drugs, statements regarding the timing of receipt of data from Skye’s Phase 2a obesity study, including its extension study, statements regarding the ability of nimacimab to perform in humans in a manner consistent with preclinical DIO data, statements regarding the potential market opportunities of nimacimab and statements regarding nimacimab’s potential to have a superior safety and tolerability profile compared to the small molecules like monlunabant,. 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: that preclinical data are not predictive of, may be inconsistent with, or more favorable than, data generated from future or ongoing clinical trial of nimacimab, including the Phase 2a study of nimacimab, competition from third parties that are developing products for similar uses, Skye’s ability to obtain, maintain and protect its intellectual property, Skye’s dependence on third parties for development and manufacture of product candidates, Skye’s ability to manage expenses and to obtain additional funding when needed to support its business activities, as well as those risks more fully described in the section entitled “Risk Factors” 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.
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