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

Key Takeaway: Corbus Pharmaceuticals has announced the dosing of the first patient in the Phase 1 clinical study for its obesity treatment, CRB-913. This next-generation CB1 inverse agonist is designed to be more peripherally restricted than earlier drugs, aiming to enhance safety by reducing neuropsychiatric risks. The trial's single ascending dose/multiple ascending dose (SAD/MAD) phase is expected to conclude by Q3 2025, followed by a Phase 1b dose-range finding study in 2026. This milestone indicates progress in addressing significant needs in effective weight loss treatments.

Market Sentiment Analysis

POSITIVE FACTORS

  • First patient has been dosed in Phase 1 clinical trial for CRB-913.
  • CRB-913 shows a significantly lower brain-to-plasma ratio compared to previous generation drugs.
  • The treatment could address multiple unmet needs in obesity management.

Full Press Release Details

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.”
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.
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.
Chief Financial Officer
Corbus Pharmaceuticals
LifeSci Advisors, LLC

Frequently Asked Questions

What is CRB-913 designed to treat?

CRB-913 is designed to treat obesity.

How does CRB-913 compare to rimonabant?

CRB-913 is significantly more peripherally restricted than rimonabant.

When will the CRB-913 Phase 1 trial be completed?

The Phase 1 trial is scheduled for completion by Q3 2025.

What does CB1 inverse agonism do?

CB1 inverse agonism is a validated mechanism for inducing weight loss.

What are the expected outcomes for CRB-913's trials?

The trials aim to establish clinical use as monotherapy and in combination therapies.

Last updated: Mar 28, 2025