Corbus Pharmaceuticals reports no neuropsychiatric events in CRB-913 trial, advancing to multiple ascending dose phase. Study completion projected for Q3 2025.
Quiver AI Summary
Corbus Pharmaceuticals Holdings Inc. has announced the start of the multiple ascending dose (MAD) portion of its Phase 1 clinical trial for CRB-913, a CB1 inverse agonist aimed at treating obesity. This follows the single ascending dose (SAD) study launched earlier in the year, which showed no treatment-related neuropsychiatric events even at higher doses than expected for efficacy. The MAD study will assess once-daily dosing of CRB-913 over a week with healthy volunteers, focusing on safety and pharmacokinetics, and is expected to conclude in the third quarter of 2025. The company plans to launch a Phase 1b dose-range finding study in obese individuals later this year. Corbus is committed to developing innovative approaches in oncology and obesity, with CRB-913 designed to minimize brain penetration to reduce adverse event risks associated with earlier CB1 inverse agonists.
Potential Positives
- No treatment-related neuropsychiatric events reported in the SAD portion of the Phase 1 trial, indicating a favorable safety profile for CRB-913.
- Initiation of the MAD portion of the Phase 1 trial demonstrates progress in clinical development for CRB-913, moving towards potential commercialization.
- Strong pre-clinical data suggests CRB-913 has significantly reduced brain penetration compared to previous CB1 inverse agonists, potentially lowering risks associated with its use.
- The upcoming Phase 1b dose-range finding study in obese individuals planned for Q4 2025 highlights the company's commitment to advancing its pipeline and addressing obesity.
Potential Negatives
- No clear efficacy results have been reported yet beyond the absence of adverse neuropsychiatric events, which may raise concerns among investors about the potential effectiveness of CRB-913.
- The timelines for ongoing and future studies extend until late 2026, indicating a longer wait for potential market entry or additional data, which could lead to investor skepticism.
- The press release notes a previous class of similar drugs was abandoned due to safety concerns, which may cast doubt on the safety profile and viability of CRB-913 amongst investors and healthcare professionals.
FAQ
What is the current status of the Phase 1 trial for CRB-913?
The Phase 1 trial for CRB-913 is progressing with the multiple ascending dose (MAD) portion set to complete in Q3 2025.
Are there any reported neuropsychiatric events related to CRB-913?
To date, no treatment-related neuropsychiatric events have been observed in the single ascending dose (SAD) portion of the trial.
When will the Phase 1b dose-range finding study begin?
The Phase 1b dose-range finding study is expected to commence in Q4 2025 following the completion of the MAD portion.
What are the key features of CRB-913?
CRB-913 is an oral small molecule CB1 inverse agonist designed to treat obesity with minimal brain penetration, reducing risks of adverse events.
Where is Corbus Pharmaceuticals headquartered?
Corbus Pharmaceuticals is headquartered in Norwood, Massachusetts, focusing on oncology and obesity treatments.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
$CRBP Insider Trading Activity
$CRBP insiders have traded $CRBP stock on the open market 5 times in the past 6 months. Of those trades, 0 have been purchases and 5 have been sales.
Here’s a breakdown of recent trading of $CRBP stock by insiders over the last 6 months:
- YUVAL COHEN (Chief Executive Officer) sold 7,134 shares for an estimated $62,464
- DOMINIC SMETHURST (Chief Medical Officer) sold 6,393 shares for an estimated $43,329
- SEAN F. MORAN (Chief Financial Officer) sold 2,792 shares for an estimated $24,446
- JOHN KENNETH JENKINS sold 2,783 shares for an estimated $20,465
- ANNE ALTMEYER sold 1,392 shares for an estimated $10,095
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$CRBP Hedge Fund Activity
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- OCTAGON CAPITAL ADVISORS LP added 2,437,000 shares (+218.6%) to their portfolio in Q1 2025, for an estimated $12,940,469
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$CRBP Analyst Ratings
Wall Street analysts have issued reports on $CRBP in the last several months. We have seen 1 firms issue buy ratings on the stock, and 0 firms issue sell ratings.
Here are some recent analyst ratings:
- B. Riley issued a "Buy" rating on 05/07/2025
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Full Release
-
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
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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.
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INVESTOR CONTACT:
Sean Moran
Chief Financial Officer
Corbus Pharmaceuticals
[email protected]
Dan Ferry
Managing Director
LifeSci Advisors, LLC
[email protected]