Corbus Pharmaceuticals Announces First Patient Dosed in Phase 1 Clinical Study of Next-Generation CB1 Inverse Agonist CRB-913 for the Treatment of Obesity

• CB1 inverse agonism is a clinically validated mechanism to induce weight loss
• CRB-913 is markedly more peripherally restricted compared to monlunabant and rimonabant
• SAD/MAD Phase 1 trial scheduled for completion Q3 2025 and Phase 1b dose-range finding scheduled for completion H2 2026
  
  

NORWOOD, Mass., March 28, 2025 (GLOBE NEWSWIRE) -- Corbus Pharmaceuticals Holdings, Inc. (NASDAQ:CRBP) ("Corbus" or the "Company"), an oncology and obesity company with a diversified portfolio, announced today the dosing of the first subject in the single ascending dose / multiple ascending dose (SAD/MAD) portion of the Phase 1 trial of CRB-913 for the treatment of obesity. The study is being conducted in the United States under an open IND.

CRB-913 is a second-generation, highly peripherally restricted cannabinoid type-1 (CB1) receptor inverse agonist drug designed to treat obesity. CB1 inverse agonism is a clinically validated mechanism to induce weight loss but the first generation of this class (e.g., rimonabant) was abandoned due to the potential risk of neuropsychiatric adverse events. A second generation of peripherally restricted CB1 inverse agonists is now being explored (e.g., monlunabant and CRB-913).  

Pre-clinical data presented at Obesity Week 2024 demonstrated CRB-913 is markedly more peripherally restricted than both monlunabant and rimonabant. In non-clinical models, CRB-913 has a brain-to-plasma ratio fifty times lower than rimonabant and is fifteen times more peripherally restricted than monlunabant.

The SAD/MAD portion of the Phase 1 trial is scheduled to be completed in Q3 of this year 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.

"We are pleased to reach this important milestone with our CRB-913 obesity program," said Yuval Cohen, Ph.D., Chief Executive Officer of Corbus. "We believe that the ability to address weight loss with this orthogonal mechanism of action and via an oral small molecule could address several key unmet needs. Our pre-clinical data to date suggests a potential clinical use as monotherapy, combination therapy with incretin analogs as well as a maintenance therapy post incretin analog induction treatment."

About Corbus

Corbus Pharmaceuticals Holdings, Inc. is an oncology and obesity company with a diversified portfolio 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 statement 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.

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INVESTOR CONTACT:

Sean Moran

Chief Financial Officer

Corbus Pharmaceuticals

[email protected]

Bruce Mackle

Managing Director

LifeSci Advisors, LLC

[email protected]