Drugs / Lenabasum
Lenabasum
Trials 7
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 25 trials · 2 met primary · 1 missed | ||||||
| Phase 2 | NCT03451045 | Dec 2017 → Jun 2020 | cystic fibrosis | Corbus Pharmaceuticals Inc. | Completed | No outcome recorded |
| Phase 2 | NCT03093402 | Dec 2017 → Jul 2021 | systemic lupus erythematosus | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | Missed primary |
| Phase 2 | NCT02465450 | Sep 2015 → Dec 2016 | cystic fibrosis | Corbus Pharmaceuticals Inc. | Completed | No outcome recorded |
| Phase 2 | NCT02465437 | Aug 2015 → Oct 2016 | diffuse cutaneous systemic sclerosis | Corbus Pharmaceuticals Inc. | Terminated | Met primary |
| Phase 2 | NCT02466243 | Jun 2015 → Aug 2017 | dermatomyositis | Corbus Pharmaceuticals Inc. | Terminated | Met primary |
| Phase 32 trials · 2 missed | ||||||
| Phase 3 | NCT03813160 | Dec 2018 → Mar 2021 | dermatomyositis | Corbus Pharmaceuticals Inc. | Completed | Missed primary |
| Phase 3 | NCT03398837 | Dec 2017 → May 2020 | diffuse cutaneous systemic sclerosis | Corbus Pharmaceuticals Inc. | Terminated | Missed primary |
News releases announcing trial results or a regulatory action · 28
| Date | Issuer | Release |
|---|---|---|
| 2021-06-24 | Corbus Pharmaceuticals Inc. | Results Corbus Pharmaceuticals Announces Topline Results from DETERMINE Phase 3 Study of Lenabasum for Treatment of Dermatomyositis corbuspharma.com ↗
The study did not meet its primary endpoint of Total Improvement Score (TIS) at Week 28. |
| 2020-11-09 | Corbus Pharmaceuticals Inc. | Results Corbus Pharmaceuticals Presents Additional Data from RESOLVE-1 Study in Systemic Sclerosis corbuspharma.com ↗
Post-hoc analyses showed lenabasum treatment was associated with a benefit in lung function (forced vital capacity) in subjects on established background immunosuppressant therapies (greater than 2 years) |
| 2020-10-23 | Corbus Pharmaceuticals Inc. | Results Corbus Pharmaceuticals Announces Presentation of Data from its Phase 2b Study in Cystic Fibrosis at NACFC 2020 corbuspharma.com ↗ |
| 2020-10-21 | Corbus Pharmaceuticals Inc. | Results Corbus Pharmaceuticals Announces Three Lenabasum Abstracts to be Presented at ACR Convergence 2020 corbuspharma.com ↗
Cannabinoid receptor type 2 expression is increased in lesional dermatomyositis skin compared to healthy skin and lenabasum significantly reduces CD8+ T cell expression of interferon γ |
| 2020-10-06 | Corbus Pharmaceuticals Inc. | Results Corbus Pharmaceuticals Announces Phase 2b Study of Lenabasum for Treatment of Cystic Fibrosis Did Not Meet Primary Endpoint corbuspharma.com ↗
The CF-002 Phase 2b trial did not meet the primary endpoint of a statistically significant reduction in rate of new PEx per subject per 28 weeks. |
| 2020-09-08 | Corbus Pharmaceuticals Inc. | Results Corbus Pharmaceuticals Announces Topline Results from RESOLVE-1 Phase 3 Study of Lenabasum for Treatment of Systemic Sclerosis corbuspharma.com ↗
Topline data showed no significant differences in the primary and secondary endpoints when comparing lenabasum to placebo, both added to background drug therapy. |
| 2020-06-29 | Corbus Pharmaceuticals Inc. | Results Corbus Pharmaceuticals Presents Data Demonstrating ACR CRISS Score Reflects Patient-Reported Outcomes at 6th Systemic Sclerosis World E-Congress corbuspharma.com ↗
The data presented in these abstracts show that the American College of Rheumatology Combined Response Index in diffuse cutaneous Systemic Sclerosis (ACR CRISS) score positively correlates with improvements in multiple patient-reported outcomes. |
| 2020-06-01 | Corbus Pharmaceuticals Inc. | Results Corbus Pharmaceuticals Announces Publication of Phase 2b Cystic Fibrosis Study Patient Demographics and Baseline Disease Characteristics in the Journal of Cystic Fibrosis corbuspharma.com ↗ |
| 2020-05-22 | Corbus Pharmaceuticals Inc. | Results Corbus Pharmaceuticals Announces Publication of Two Abstracts at EULAR 2020 E-Congress corbuspharma.com ↗
Lenabasum, a CB2 agonist, inhibits inflammasome activation |
| 2020-04-29 | Corbus Pharmaceuticals Inc. | Results Corbus Announces Publication of Lenabasum Systemic Sclerosis Double-Blind, Placebo-Controlled Phase 2 Clinical Trial Results in Arthritis & Rheumatology corbuspharma.com ↗ |
| 2019-11-11 | Corbus Pharmaceuticals Inc. | Results Corbus Pharmaceuticals Updates Data from Lenabasum Open-Label Extension Studies in Systemic Sclerosis and Dermatomyositis at 2019 ACR Annual Meeting corbuspharma.com ↗
Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) (“Corbus” or the “Company”), a clinical-stage drug development company pioneering transformative medicines that target the endocannabinoid system, today announced continued favorable safety and efficacy outcomes in open-label extensions (OLE) of lenabasum Phase 2 studies in two rare and serious autoimmune diseases: systemic sclerosis (SSc) and dermatomyositis (DM). |
| 2019-06-12 | Corbus Pharmaceuticals Inc. | Results Lenabasum Open-Label Extension Data to be Presented at EULAR 2019 Continue to Show a Favorable Safety Profile and Improvement in Efficacy Outcomes in Systemic Sclerosis and Dermatomyositis Phase 2 Studies corbuspharma.com ↗
Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) (“Corbus” or the “Company”) today announced continued favorable safety and durable improvement in efficacy outcomes at 21 months compared to 12 months in open-label extensions (OLE) of lenabasum Phase 2 studies in two rare and serious autoimmune diseases: systemic sclerosis (SSc) and dermatomyositis (DM). |
| 2018-10-22 | Corbus Pharmaceuticals Inc. | Results Corbus Pharmaceuticals Presents Lenabasum Long-Term Open-Label Clinical Data Showing Maintenance of Favorable Safety Profile and Further Improvement in Multiple Efficacy Endpoints in Systemic Sclerosis and Dermatomyositis Phase 2 Studies corbuspharma.com ↗
Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) (“Corbus” or the “Company”), a clinical stage drug development company with the industry’s leading pipeline focused on treating inflammatory and fibrotic diseases by targeting the endocannabinoid system, today announced continued favorable safety and tolerability profiles and further improvement in efficacy outcomes in open-label extensions (OLEs) of lenabasum Phase 2 studies in two rare and serious autoimmune diseases, systemic sclerosis (SSc) and dermatomyositis (DM). |
| 2018-10-18 | Corbus Pharmaceuticals Inc. | Results Corbus Pharmaceuticals Presents Data on Impact of Lenabasum on Inflammation of Airway Macrophages from Cystic Fibrosis Lungs at the 2018 North American Cystic Fibrosis Conference corbuspharma.com ↗
Study demonstrates that lenabasum decreases inflammatory biomarkers and increases pro-resolving mediators in airway macrophages from cystic fibrosis patients |
| 2018-09-18 | Corbus Pharmaceuticals Inc. | Regulatory Corbus Pharmaceuticals Receives Orphan Designation for Lenabasum for the Treatment of Dermatomyositis in the European Union corbuspharma.com ↗ |
| 2018-07-20 | Corbus Pharmaceuticals Inc. | Regulatory Corbus Pharmaceuticals Receives FDA Orphan Drug Designation for Lenabasum for the Treatment of Dermatomyositis corbuspharma.com ↗ |
| 2018-06-13 | Corbus Pharmaceuticals Inc. | Results Corbus Pharmaceuticals Presents 1-Year Systemic Sclerosis and 6-Month Dermatomyositis Data from Open-Label Extension of Phase 2 Lenabasum Studies at EULAR 2018 corbuspharma.com ↗
Key highlights from the data being presented include: SSc OLE 1-Year Results mRSS improved by a mean of -9.4 from baseline at the start of the Phase 2 double-blind, placebo-controlled phase of the study; |
| 2018-02-15 | Corbus Pharmaceuticals Inc. | Results Corbus Pharmaceuticals Announces Publication Demonstrating Lenabasum as First Drug to Stimulate Resolution of Innate Immune Responses in a Clinical Model corbuspharma.com ↗
The results identify the CB2 receptor, the therapeutic target of lenabasum, as a key link between the innate immune response and the endocannabinoid system acting as an upstream activator of the resolution of innate immunity. |
| 2018-01-29 | Corbus Pharmaceuticals Inc. | Regulatory Corbus Pharmaceuticals Announces Agreement with FDA on Phase 2b Cystic Fibrosis Study Design with Pulmonary Exacerbations as Sole Primary Endpoint corbuspharma.com ↗
The Company and the FDA agreed that the event rate of pulmonary exacerbation is an acceptable sole primary efficacy endpoint for the clinical development program to support registration of lenabasum for the treatment of CF. |
| 2017-11-06 | Corbus Pharmaceuticals Inc. | Results Corbus Pharmaceuticals Reports Significant Improvement in mRSS and Other Clinical Outcomes at 28-Weeks in Systemic Sclerosis Open-Label Extension of Phase 2 Study corbuspharma.com ↗
Anabasum demonstrated a significant and clinically meaningful reduction in mRSS reaching minus 8.4 (p < 0.0001 2-paired t-test) and an ACR CRISS of 71% at 28 weeks OLE. |
| 2017-10-19 | Corbus Pharmaceuticals Inc. | Results Corbus Pharmaceuticals Reports Positive Topline Results from Phase 2 Study in Rare Autoimmune Disease Dermatomyositis corbuspharma.com ↗
Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) ("Corbus" or the "Company"), a clinical stage drug development company targeting rare, chronic, serious inflammatory and fibrotic diseases, today announced positive topline results from its 16-week Phase 2 study of safety and efficacy of anabasum in dermatomyositis ("DM"). |
| 2017-06-15 | Corbus Pharmaceuticals Inc. | Results Corbus Pharmaceuticals Presented Data from Phase 2 Study of Anabasum for the Treatment of Systemic Sclerosis at the EULAR 2017 Annual Meeting corbuspharma.com ↗
The presentation included a review of the Phase 2 topline data previously announced, additional data from the study regarding Patient-Reported Outcomes Measurement Information System (PROMIS)-29, and additional analysis of the previously-reported CRISS domains and transcriptome data. |
| 2017-03-30 | Corbus Pharmaceuticals Inc. | Results Corbus Pharmaceuticals Reports Positive Topline Data Demonstrating Anabasum Reduces Acute Pulmonary Exacerbations and Multiple Inflammatory Biomarkers in Phase 2 Study in Patients with Cystic Fibrosis corbuspharma.com ↗
Anabasum successfully achieved the primary objective of the study by demonstrating an acceptable safety and tolerability profile at all doses with no serious or severe adverse events related to the study drug. |
| 2017-03-08 | Corbus Pharmaceuticals Inc. | Results Corbus Pharmaceuticals to Present Gene Expression Data from Recent Phase 2 Systemic Sclerosis Study Demonstrating JBT-101 Inhibits Inflammation and Fibrosis Pathways corbuspharma.com ↗
Dr. Whitfield will present data showing distinct differences in gene expression profiles between skin biopsy samples from systemic sclerosis patients receiving JBT-101 and those receiving placebo. |
| 2017-02-23 | Corbus Pharmaceuticals Inc. | Results Corbus Pharmaceuticals Announces Preclinical Data Demonstrating JBT-101 Reduces Inflammation in Alveolar Macrophages from Cystic Fibrosis Patients corbuspharma.com ↗
Alveolar Macrophages treated with JBT-101 demonstrated reduced levels of key pro-inflammatory cytokines, TNF- alpha and IL-6 |
| 2017-01-17 | Corbus Pharmaceuticals Inc. | Regulatory Corbus Pharmaceuticals Receives Orphan Designation for JBT-101 for the Treatment of Systemic Sclerosis in the European Union corbuspharma.com ↗
Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) ("Corbus" or the "Company"), a clinical stage drug development company targeting rare, chronic, serious inflammatory and fibrotic diseases, announced today that the European Commission has granted Orphan Designation in the European Union ("EU") for the Company's novel synthetic oral endocannabinoid-mimetic drug, JBT-101 ("Resunab") for the treatment of systemic sclerosis . |
| 2016-11-14 | Corbus Pharmaceuticals Inc. | Results Corbus Pharmaceuticals Reports Positive Topline Results Showing Clear Signal of Clinical Benefit with Resunab (JBT-101) in Phase 2 Study in Systemic Sclerosis corbuspharma.com ↗
JBT-101 out-performed placebo in the American College of Rheumatology (ACR) Combined Response Index in diffuse cutaneous Systemic Sclerosis (CRISS) score, reaching 33% at week 16, versus 0% for placebo. |
| 2016-09-28 | Corbus Pharmaceuticals Inc. | Results Corbus Announces Data on Effects of Resunab (JBT-101) in a Clinical Research Model of Resolution of Inflammation corbuspharma.com ↗
Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) ("Corbus" or the "Company"), a clinical stage drug development company targeting rare, chronic and serious inflammatory and fibrotic diseases, announced today that Professor Derek Gilroy, Ph.D. presented data on the effects of Resunab in a model of inflammation in healthy volunteers on September 28, 2016. |
All press releases naming this drug 66 releases
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 8 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | lenabasum | “JBT-101 (lenabasum)” NCT02465450 ↗ |
| Known as | Ajulemic acid | ChEMBL registry synonym — accepted as the source's own label CHEMBL456341 ↗ |
| Known as | CPL-7075 | ChEMBL registry synonym — accepted as the source's own label CHEMBL456341 ↗ |
| Known as | HU-239 | ChEMBL registry synonym — accepted as the source's own label CHEMBL456341 ↗ |
| Known as | IP-751 | ChEMBL registry synonym — accepted as the source's own label CHEMBL456341 ↗ |
| Known as | JBT-101 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02465450 ↗ |
| Known as | Resunab | ChEMBL registry synonym — accepted as the source's own label CHEMBL456341 ↗ |
| Action | Activate | “JBT-101 is a synthetic endocannabinoid receptor type 2 (CB2) agonist” NCT03093402 ↗ |
| Modality | Small molecule | — CHEMBL456341 ↗ |
| Route | Oral | “JBT-101 by mouth (orally)” NCT03093402 ↗ |