Corbus Pharmaceuticals Initiates Multiple Ascending Dose Portion of Phase 1 Study of Highly Peripherally Restricted CB1 Inverse Agonist CRB-913 for the Treatment of Obesity
Corbus Pharmaceuticals (NASDAQ: CRBP) has initiated the multiple ascending dose (MAD) portion of its Phase 1 trial for CRB-913, a highly peripherally restricted CB1 inverse agonist targeting obesity treatment. This advancement follows the successful completion of the single ascending dose (SAD) study's safety and pharmacokinetics analysis.
The MAD study will evaluate once-daily dosing of CRB-913 for 7 days in healthy volunteers, focusing on safety, tolerability, and pharmacokinetics. Notably, no treatment-related neuropsychiatric events were observed during the SAD portion, even at doses significantly higher than those expected for clinical efficacy.
The company has outlined a clear development timeline: The SAD/MAD portion is scheduled for completion in Q3 2025, followed by a Phase 1b dose-range finding study in obese individuals starting in Q4 2025, with completion expected in the second half of 2026.
Corbus Pharmaceuticals (NASDAQ: CRBP) ha avviato la fase a dosi multiple ascendenti (MAD) del suo trial di Fase 1 per CRB-913, un potente agonista inverso CB1 con restrizione periferica, destinato al trattamento dell'obesità. Questo progresso segue il completamento con successo dell'analisi di sicurezza e farmacocinetica dello studio a dose singola ascendente (SAD).
Lo studio MAD valuterà la somministrazione giornaliera di CRB-913 per 7 giorni in volontari sani, concentrandosi su sicurezza, tollerabilità e farmacocinetica. È importante sottolineare che durante la fase SAD non sono stati osservati eventi neuropsichiatrici correlati al trattamento, anche a dosi significativamente superiori a quelle previste per l'efficacia clinica.
L'azienda ha delineato un chiaro calendario di sviluppo: la fase SAD/MAD è prevista per il completamento nel terzo trimestre del 2025, seguita da uno studio di Fase 1b per la determinazione della dose in soggetti obesi a partire dal quarto trimestre del 2025, con conclusione attesa nella seconda metà del 2026.
Corbus Pharmaceuticals (NASDAQ: CRBP) ha iniciado la fase de dosis múltiples ascendentes (MAD) de su ensayo de Fase 1 para CRB-913, un potente agonista inverso CB1 con restricción periférica, dirigido al tratamiento de la obesidad. Este avance sigue a la finalización exitosa del análisis de seguridad y farmacocinética del estudio de dosis única ascendente (SAD).
El estudio MAD evaluará la administración diaria de CRB-913 durante 7 días en voluntarios sanos, enfocándose en la seguridad, tolerabilidad y farmacocinética. Cabe destacar que durante la fase SAD no se observaron eventos neuropsiquiátricos relacionados con el tratamiento, incluso a dosis significativamente superiores a las esperadas para la eficacia clínica.
La compañía ha establecido un cronograma claro de desarrollo: la fase SAD/MAD está programada para completarse en el tercer trimestre de 2025, seguida de un estudio de Fase 1b para determinar el rango de dosis en personas obesas que comenzará en el cuarto trimestre de 2025, con finalización prevista para la segunda mitad de 2026.
코르부스 파마슈티컬스(NASDAQ: CRBP)는 비만 치료를 목표로 하는 말초 제한성이 높은 CB1 역작용제 CRB-913의 1상 임상시험 중 다회 상승 용량(MAD) 단계를 시작했습니다. 이 진전은 단회 상승 용량(SAD) 연구의 안전성 및 약동학 분석이 성공적으로 완료된 데 따른 것입니다.
MAD 연구는 건강한 자원자들을 대상으로 7일간 하루 한 번 CRB-913 투여를 평가하며, 안전성, 내약성 및 약동학에 중점을 둡니다. 특히, 임상 효능에 필요한 용량보다 훨씬 높은 용량에서도 SAD 단계에서 치료 관련 신경정신학적 부작용은 관찰되지 않았습니다.
회사는 명확한 개발 일정도 제시했습니다: SAD/MAD 단계는 2025년 3분기에 완료될 예정이며, 이후 2025년 4분기부터 비만 환자를 대상으로 한 1b상 용량 탐색 연구가 시작되어 2026년 하반기에 완료될 계획입니다.
Corbus Pharmaceuticals (NASDAQ : CRBP) a lancé la phase à doses multiples ascendantes (MAD) de son essai de phase 1 pour CRB-913, un agoniste inverse CB1 fortement restreint en périphérie, ciblant le traitement de l'obésité. Cette avancée fait suite à la réussite de l'analyse de sécurité et de pharmacocinétique de l'étude à dose unique ascendante (SAD).
L'étude MAD évaluera la prise quotidienne de CRB-913 pendant 7 jours chez des volontaires sains, en se concentrant sur la sécurité, la tolérance et la pharmacocinétique. Il est important de noter qu'aucun événement neuropsychiatrique lié au traitement n'a été observé lors de la phase SAD, même à des doses nettement supérieures à celles attendues pour une efficacité clinique.
La société a établi un calendrier de développement clair : la phase SAD/MAD devrait être terminée au 3e trimestre 2025, suivie d'une étude de phase 1b visant à déterminer la plage de doses chez des personnes obèses à partir du 4e trimestre 2025, avec une finalisation prévue pour la seconde moitié de 2026.
Corbus Pharmaceuticals (NASDAQ: CRBP) hat den Abschnitt mit mehrfach ansteigenden Dosen (MAD) seiner Phase-1-Studie für CRB-913 gestartet, einen stark peripher eingeschränkten CB1-Inversagonisten zur Behandlung von Adipositas. Dieser Fortschritt folgt auf den erfolgreichen Abschluss der Sicherheits- und Pharmakokinetikanalyse der Einzelanwendungsdosis-Studie (SAD).
Die MAD-Studie wird die einmal tägliche Gabe von CRB-913 über 7 Tage bei gesunden Probanden untersuchen, mit Fokus auf Sicherheit, Verträglichkeit und Pharmakokinetik. Bemerkenswert ist, dass während der SAD-Phase keine behandlungsbedingten neuropsychiatrischen Ereignisse beobachtet wurden, selbst bei Dosen, die deutlich über denen liegen, die für eine klinische Wirksamkeit erwartet werden.
Das Unternehmen hat einen klaren Entwicklungszeitplan festgelegt: Der SAD/MAD-Abschnitt soll im 3. Quartal 2025 abgeschlossen sein, gefolgt von einer Phase-1b-Dosisfindungsstudie bei adipösen Personen, die im 4. Quartal 2025 beginnt und deren Abschluss für die zweite Hälfte 2026 erwartet wird.
- No treatment-related neuropsychiatric events observed in SAD portion, even at high doses
- Successful translation from pre-clinical models to clinical settings
- Clear development timeline established through 2026
- Study progressing on schedule with next phase initiation in Q4 2025
- None.
Insights
Corbus advances obesity drug to next phase with promising safety data, targeting large market opportunity with differentiated approach.
Corbus's progression from single to multiple ascending dose (MAD) testing for CRB-913 represents an important development milestone in their obesity program. The absence of treatment-related neuropsychiatric events in the single dose portion is particularly significant for a CB1 inverse agonist. Earlier compounds in this class like rimonabant showed excellent weight loss efficacy but failed due to serious central nervous system side effects including depression and suicidal ideation.
The company's strategic focus on a "highly peripherally restricted" compound aims to maintain metabolic benefits while minimizing brain penetration. The reported safety profile at doses exceeding anticipated therapeutic levels suggests a potentially wide therapeutic window - a critical factor for obesity medications requiring chronic administration.
The structured development approach follows industry standards: testing first in healthy volunteers before advancing to the target obese population in Q4 2025. This methodical progression indicates disciplined development rather than rushed advancement.
For context, the obesity treatment landscape has been transformed by GLP-1 agonists, creating a multi-billion dollar market opportunity. A novel mechanism like CB1 antagonism could potentially complement existing approaches, especially if it demonstrates favorable efficacy, tolerability, or dosing convenience in later-stage trials.
While this news represents positive progression, investors should recognize we're still in early-stage development focused on safety rather than efficacy endpoints. The true value proposition won't be established until the dose-range finding study in obese individuals scheduled for completion in H2 2026.
- No treatment-related neuropsychiatric events seen to date in SAD portion of Phase 1
MAD study on track for completion in Q3 2025
NORWOOD, Mass., June 30, 2025 (GLOBE NEWSWIRE) -- Corbus Pharmaceuticals Holdings Inc. (NASDAQ: CRBP), a clinical-stage company focused on oncology and obesity, today announced the initiation of the multiple ascending dose (MAD) portion of its Phase 1 trial for CRB-913, a highly peripherally restricted CB1 inverse agonist for the treatment of obesity. This follows safety and pharmacokinetics (PK) data analysis of the single ascending dose (SAD) study launched in March. The MAD portion of this clinical study is scheduled for completion in the third quarter of this year.
The MAD portion of the Phase 1 trial is designed to test a once-daily dosing of CRB-913 for 7 days. Similarly to the SAD study, the MAD study is undertaken with healthy volunteers and focuses on safety, tolerability and PK of increasing doses of CRB-913. The study is being conducted in the United States.
“The data collected to date shows a satisfactory translation from pre-clinical models to the clinical settings,” said Yuval Cohen, PhD, CEO of Corbus. “An absence of treatment-related neuropsychiatric events was noted even at markedly higher doses than our modelling suggests would be required to achieve efficacy in clinical practice. We look forward to generating further clinical evidence in the multiple ascending dose cohorts before initiating a Phase 1b dose-range finding study in obese individuals later this year.”
The SAD/MAD portion of the Phase 1 trial is scheduled to be completed in Q3 of 2025, and the Company expects to commence a Phase 1b dose-range finding study in Q4 of 2025. The dose-range finding study is scheduled for completion in the second half of 2026.
About CRB-913
CRB-913 is an oral small molecule inverse agonist of the G-protein Coupled Receptor (GPCR) cannabinoid type-1 (CB1). This is a recognized mechanism of action for weight loss, but the previous class of such experimental drugs was abandoned due to potential neuropsychiatric adverse event risks. CRB-913 is a member of a new class of peripherally restricted CB1 inverse agonists designed to have reduced brain penetration. Pre-clinical models have shown CRB-913 to be 15-fold less brain penetrant than monlunabant (another experimental CB1 inverse agonist) and to have 50 times lower brain:plasma ratio than rimonabant (an extensively studied first generation CB1 inverse agonist).
About Corbus
Corbus Pharmaceuticals Holdings, Inc. is a clinical-stage company focused on oncology and obesity and is committed to helping people defeat serious illness by bringing innovative scientific approaches to well-understood biological pathways. Corbus’ pipeline includes CRB-701, a next-generation antibody drug conjugate that targets the expression of Nectin-4 on cancer cells to release a cytotoxic payload, CRB-601, an anti-integrin monoclonal antibody that blocks the activation of TGFβ expressed on cancer cells, and CRB-913, a highly peripherally restricted CB1 receptor inverse agonist for the treatment of obesity. Corbus is headquartered in Norwood, Massachusetts. For more information on Corbus, visit corbuspharma.com. Connect with us on X, LinkedIn and Facebook.
Forward-Looking Statements
This press release contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and Private Securities Litigation Reform Act, as amended, including those relating to the Company’s trial results, product development, clinical and regulatory timelines, including timing for completion of trials and presentation of data, market opportunity, competitive position, possible or assumed future results of operations, business strategies, potential growth opportunities and other statements that are predictive in nature. These forward-looking statements are based on current expectations, estimates, forecasts and projections about the industry and markets in which we operate and management’s current beliefs and assumptions.
These statements may be identified by the use of forward-looking expressions, including, but not limited to, “expect,” “anticipate,” “intend,” “plan,” “believe,” “estimate,” “potential,” “predict,” “project,” “should,” “would” and similar expressions and the negatives of those terms. These statements relate to future events or our financial performance and involve known and unknown risks, uncertainties, and other factors on our operations, clinical development plans and timelines, which may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Such factors include those set forth in the Company’s filings with the Securities and Exchange Commission. Prospective investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this press release. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.
All product names, logos, brands and company names are trademarks or registered trademarks of their respective owners. Their use does not imply affiliation or endorsement by these companies.
INVESTOR CONTACT:
Sean Moran
Chief Financial Officer
Corbus Pharmaceuticals
smoran@corbuspharma.com
Dan Ferry
Managing Director
LifeSci Advisors, LLC
daniel@lifesciadvisors.com
FAQ
What is the purpose of Corbus Pharmaceuticals' (CRBP) CRB-913 clinical trial?
What are the key findings from CRBP's Phase 1 SAD study of CRB-913?
When will Corbus Pharmaceuticals complete the Phase 1 SAD/MAD trial for CRB-913?
What is the next step in CRBP's development timeline for CRB-913?
How is the Multiple Ascending Dose (MAD) portion of CRBP's CRB-913 trial designed?
