GlobeNewswire BiotechnologyCodex · 实盘不做把握 4/10
北京时间·🕒 发布 20:30:00时区推断·⟳ 抓取 20:32:43·⚡ 决策 08-04 22:25:02 +1h52m·84.0 天前
Corbus宣布CRB-913肥胖症1b期试验完成末例末访并维持9月读出
CANYON-1为240例、16周剂量探索1b期试验,末例末访说明9月topline读出进度正常,但今天没有披露新的有效性或安全性结果。
📄 原文GlobeNewswire Biotechnology↗ 原文
- Dose-finding Phase 1b study (n=240) on track for topline data in September 2026 - CANYON-1 follows promising data fro…
不做 Corbus Pharmaceuticals(CRBP.US)
临床末例末访只是读出前进度确认,核心数据要到2026年9月才公布,当前没有足够事件交易edge。
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研究档案
🔎 新鲜度:最早出现 2026-08-04 · 扩散 low · price-in 风险 medium ↗
关键理由
- CANYON-1为240例、16周剂量探索1b期试验,末例末访说明9月topline读出进度正常,但今天没有披露新的有效性或安全性结果。
主要风险
- 肥胖药读出才是核心二元催化,末例末访更多是时间表确认,提前交易容易变成读出前事件风险敞口。
原文全文
展开原文 · 6,507 字
- Dose-finding Phase 1b study (n=240) on track for topline data in September 2026
- CANYON-1 follows promising data from Phase 1a SAD/MAD study that demonstrated differentiated GI tolerability from GLP-1 class
- CRB-913 yielded 15 times lower brain penetration than monlunabant in mice
NORWOOD, Mass., Aug. 04, 2026 (GLOBE NEWSWIRE) -- Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP), a clinical-stage company focused on new therapies in oncology and obesity, today announced the last patient has completed their last clinical visit (“Last Patient Last Visit”) in the Company’s CANYON-1 Phase 1b clinical trial of CRB-913 for the treatment of obesity. The CANYON-1 study is on track for topline data readout in September 2026. CRB-913 is a once-daily highly peripherally restricted oral CB1 inverse agonist potentially offering an orthogonal approach to weight loss and long-term weight management and a new therapeutic option for obesity beyond GLP-1 and other incretin-targeting therapies.
The CANYON-1 Phase 1b clinical trial is a 16-week double-blind, placebo-controlled, dose-ranging study in 240 obese, non-diabetic adult participants conducted at multiple clinical sites in the United States (NCT07310901). The trial includes three CRB-913 cohorts of 20 mg, 40 mg, and 60 mg dosed orally once-daily (QD) as well as a placebo cohort (randomization of 1:1:1:1). A dose titration regimen was included in the design, with all participants receiving CRB-913 commencing at 20 mg/day and then titrating up to either 40 mg/day or beyond that to 60 mg/day, depending on their assigned cohorts. Participants were dosed for 12-weeks followed by a four-week safety follow-up.
“Despite the remarkable success of GLP-1s and the incretin class, significant treatment gaps exist for people struggling with obesity,” said Yuval Cohen, Ph.D., Chief Executive Officer of Corbus. “Over 60% of those who try incretin therapy discontinue it in their first year, often as a result of intolerance or lack of satisfactory response to this therapy. Our upcoming data readout of the CANYON-1 study will help further inform CRB-913's potential to deliver an orthogonal, oral, non-incretin therapeutic option for effective weight loss and sustained weight management. Importantly, CANYON-1 is expected to provide clarifying insights as to its safety and efficacy and allow us to contextualize the data in comparison to both oral GLP-1 agonists as well as the CB1 inverse agonist monlunabant.”
About the CRB-913 Phase 1a Study Findings
Corbus completed a single ascending dose (SAD) and multiple ascending dose (MAD) Phase 1a study of CRB-913 in December 2025. The SAD portion of the trial enrolled 64 participants across 8 cohorts. The MAD portion enrolled 48 participants across 4 cohorts, including a dedicated obese cohort. The highest SAD dose tested was 600 mg/day, and the highest MAD dose tested was 150 mg/day. In the dedicated obese MAD cohort (150 mg/day), all CRB-913-treated participants (n=9), and none in the placebo group (n=3), experienced weight loss. The CRB-treated participants achieved a mean 2.9% placebo-adjusted weight loss by Day 14. Weight loss started early and deepened with time. CRB-913 was safe and well-tolerated across all cohorts and all doses studied, including demonstrating a very favorable GI profile with no reports of vomiting, constipation or nausea. Daily neuropsychiatric assessments using CSSRS, PHQ-9, and GAD-7 were negative.
About Corbus
Corbus Pharmaceuticals Holdings, Inc. is a clinical-stage company focusing on new therapies in 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 for the treatment of Nectin-4-expressing tumors, and CRB-913, an orally delivered highly peripherally restricted CB1 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 statements relating to the anticipated timing of topline data from the CANYON-1 study, the Company’s trial results, product development, clinical and regulatory timelines, including timing for completion of trials and presentation of data, the potential of CRB-913 relative to GLP-1 and other incretin-targeting therapies and to monlunabant, 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.
INVESTOR CONTACTS:
Sean Moran
Chief Financial Officer
Corbus Pharmaceuticals
smoran@corbuspharma.com
Dan Ferry
Managing Director
LifeSci Advisors, LLC
daniel@lifesciadvisors.com
MEDIA CONTACT:
Liz Melone
Founder & Principal
Melone Communications, LLC
liz@melonecomm.com
- CANYON-1 follows promising data from Phase 1a SAD/MAD study that demonstrated differentiated GI tolerability from GLP-1 class
- CRB-913 yielded 15 times lower brain penetration than monlunabant in mice
NORWOOD, Mass., Aug. 04, 2026 (GLOBE NEWSWIRE) -- Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP), a clinical-stage company focused on new therapies in oncology and obesity, today announced the last patient has completed their last clinical visit (“Last Patient Last Visit”) in the Company’s CANYON-1 Phase 1b clinical trial of CRB-913 for the treatment of obesity. The CANYON-1 study is on track for topline data readout in September 2026. CRB-913 is a once-daily highly peripherally restricted oral CB1 inverse agonist potentially offering an orthogonal approach to weight loss and long-term weight management and a new therapeutic option for obesity beyond GLP-1 and other incretin-targeting therapies.
The CANYON-1 Phase 1b clinical trial is a 16-week double-blind, placebo-controlled, dose-ranging study in 240 obese, non-diabetic adult participants conducted at multiple clinical sites in the United States (NCT07310901). The trial includes three CRB-913 cohorts of 20 mg, 40 mg, and 60 mg dosed orally once-daily (QD) as well as a placebo cohort (randomization of 1:1:1:1). A dose titration regimen was included in the design, with all participants receiving CRB-913 commencing at 20 mg/day and then titrating up to either 40 mg/day or beyond that to 60 mg/day, depending on their assigned cohorts. Participants were dosed for 12-weeks followed by a four-week safety follow-up.
“Despite the remarkable success of GLP-1s and the incretin class, significant treatment gaps exist for people struggling with obesity,” said Yuval Cohen, Ph.D., Chief Executive Officer of Corbus. “Over 60% of those who try incretin therapy discontinue it in their first year, often as a result of intolerance or lack of satisfactory response to this therapy. Our upcoming data readout of the CANYON-1 study will help further inform CRB-913's potential to deliver an orthogonal, oral, non-incretin therapeutic option for effective weight loss and sustained weight management. Importantly, CANYON-1 is expected to provide clarifying insights as to its safety and efficacy and allow us to contextualize the data in comparison to both oral GLP-1 agonists as well as the CB1 inverse agonist monlunabant.”
About the CRB-913 Phase 1a Study Findings
Corbus completed a single ascending dose (SAD) and multiple ascending dose (MAD) Phase 1a study of CRB-913 in December 2025. The SAD portion of the trial enrolled 64 participants across 8 cohorts. The MAD portion enrolled 48 participants across 4 cohorts, including a dedicated obese cohort. The highest SAD dose tested was 600 mg/day, and the highest MAD dose tested was 150 mg/day. In the dedicated obese MAD cohort (150 mg/day), all CRB-913-treated participants (n=9), and none in the placebo group (n=3), experienced weight loss. The CRB-treated participants achieved a mean 2.9% placebo-adjusted weight loss by Day 14. Weight loss started early and deepened with time. CRB-913 was safe and well-tolerated across all cohorts and all doses studied, including demonstrating a very favorable GI profile with no reports of vomiting, constipation or nausea. Daily neuropsychiatric assessments using CSSRS, PHQ-9, and GAD-7 were negative.
About Corbus
Corbus Pharmaceuticals Holdings, Inc. is a clinical-stage company focusing on new therapies in 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 for the treatment of Nectin-4-expressing tumors, and CRB-913, an orally delivered highly peripherally restricted CB1 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 statements relating to the anticipated timing of topline data from the CANYON-1 study, the Company’s trial results, product development, clinical and regulatory timelines, including timing for completion of trials and presentation of data, the potential of CRB-913 relative to GLP-1 and other incretin-targeting therapies and to monlunabant, 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.
INVESTOR CONTACTS:
Sean Moran
Chief Financial Officer
Corbus Pharmaceuticals
smoran@corbuspharma.com
Dan Ferry
Managing Director
LifeSci Advisors, LLC
daniel@lifesciadvisors.com
MEDIA CONTACT:
Liz Melone
Founder & Principal
Melone Communications, LLC
liz@melonecomm.com
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