- |||||||||| Resunab (lenabasum) / Corbus Pharma, Kaken Pharma
Journal: Evaluating the Abuse Potential of Lenabasum, a Selective CB2 Cannabinoid Receptor Agonist. (Pubmed Central) - Oct 19, 2024 CB1 and CB2 agonists exhibit broad anti-inflammatory properties, suggesting their potential to treat inflammatory diseases...Three doses of lenabasum (20, 60, and 120 mg) were compared with placebo and nabilone (3 and 6 mg)...Significance Statement This work provides evidence that in people with a history of recreational cannabis use, lenabasum was safe and well-tolerated, although it did demonstrate abuse potential. This work supports further development of lenabasum for potential therapeutic indications.
- |||||||||| Resunab (lenabasum) / Corbus Pharma, Kaken Pharma, Cesamet (nabilone) / Bausch Health, Viatris
Journal: The Features of Shared Genes among Transcriptomes Probed in Atopic Dermatitis, Psoriasis, and Inflammatory Acne: S100A9 Selection as the Target Gene. (Pubmed Central) - May 20, 2024 Data from OLE and subsequent follow-up periods demonstrate lenabasum's efficacy in maintaining disease stability, reducing flares, and improving DM symptoms, suggesting that it is a promising option for patients with treatment-resistant skin-predominant DM. Overall, our approach may become an effective strategy for discovering new disease candidate genes for inflammatory skin diseases with a reevaluation of clinical data.
- |||||||||| Sativex (nabiximols) / Jazz, lenabasum (JBT-101) / Corbus Pharma, Kaken Pharma, Cesamet (nabilone) / Bausch Health, Viatris
Efficacy and Safety of Cannabis Use in Rheumatology: a Scoping Review of Condition- Specific Outcomes () - Feb 8, 2024 - Abstract #CRAAHPA2024CRA_AHPA_183; However, the current literature focuses on fibromyalgia and data for other rheumatologic conditions is sparse. Future studies should include a broader range of rheumatologic conditions and gather more long-term safety data using more robust methodologies, such as randomized controlled trials.
- |||||||||| lenabasum (JBT-101) / Corbus Pharma, Kaken Pharma
Journal: Syntheses of Cannabinoid Metabolites: Ajulemic Acid and HU-210. (Pubmed Central) - Jan 30, 2024 Herein, we optimized the key allylic oxidation step to introduce the C-11 hydroxy group with a high yield. A series of compounds was prepared with this condition applied including HU-210, 11-nor-?-tetrahydrocannabinol (THC)-carboxylic acid and ?-THC-carboxylic acid.
- |||||||||| lenabasum (JBT-101) / Corbus Pharma, Kaken Pharma
Performance of the Revised CRISS in a Phase 3 Trial of Early Systemic Sclerosis (Poster Hall; in person) - Sep 23, 2023 - Abstract #ACRConvergence2023ACR_Convergence_3578; The mRSS and CGA drove the Revised CRISS in this RCT, and the future trials should enrich for more severe skin involvement (progressive skin phenotype and less regressive disease) to limit improvement in mRSS (as part of the natural history). In addition, stratification by autoantibodies and background immunosuppressives may balance the Revised CRISS response.
- |||||||||| lenabasum (JBT-101) / Corbus Pharma, Kaken Pharma
Session II Basic and Clinical Studies of Rheumatic Diseases:The total improvement score (TIS) in a phase 3 clinical trial for dermatomyositis(DM): Room for improvement? (Ito Hall, University of Tokyo) - Mar 4, 2023 - Abstract #ISID2023ISID_1786; It also includes the Cutaneous DermatomyositisDisease Area and Severity Index-Activity (CDASI-A) score, weighted the same as MMT.To compare efficacy of scores, data from a Phase 3 trial of lenabasum in DM wereevaluated (Baseline vs Week 52)...Itprovides about twice the treatment effect for R vs NR in both muscle and skin withoutany increase in score in NR and assigns greater weight to PtGA. DMOMS may be bettersuited to detect treatment effect in DM clinical trials that include patients with all DMphenotypes, even with a smaller sample size.
- |||||||||| lenabasum (JBT-101) / Corbus Pharma, Kaken Pharma
The total improvement score (TIS) in a phase 3 clinical trial for dermatomyositis (DM): Room for improvement? () - Mar 4, 2023 - Abstract #ISID2023ISID_916; To compare efficacy of scores, data from a Phase 3 trial of lenabasum in DM were evaluated (Baseline vs Week 52)...It provides about twice the treatment effect for R vs NR in both muscle and skin without any increase in score in NR and assigns greater weight to PtGA. DMOMS may be better suited to detect treatment effect in DM clinical trials that include patients with all DM phenotypes, even with a smaller sample size.
- |||||||||| lenabasum (JBT-101) / Corbus Pharma, Kaken Pharma
CDASI-activity vs IGA scores for dermatomyositis in the lenabasum phase 3 trial () - Mar 4, 2023 - Abstract #ISID2023ISID_859; For IGA, this value is less than a 1-point change and is smaller than the currently used 2-point change threshold for meaningful change. This study is a novel assessment of the CDASI-A and IGA outcomes from the investigator
- |||||||||| lenabasum (JBT-101) / Corbus Pharma, Kaken Pharma
Lenabasum and its interaction with dermatomyositis leukocyte signaling pathways () - Mar 4, 2023 - Abstract #ISID2023ISID_679; These cells were also stained for IFN-b, IFN-g, and NFKb as markers for inflammatory activity. The results of this study will aid in uncovering the mechanisms behind the response to a CB2R agonist and allow clinicians to better understand the heterogeneity of cellular signaling and response that can account for variability of clinical response.
- |||||||||| lenabasum (JBT-101) / Corbus Pharma, Kaken Pharma
Lenabasum Reduces IFNγ and pIRF3 in Dermatomyositis Skin: Biomarker Results from a Double-Blind Phase 3 International Randomized Controlled Trial (Virtual Poster Hall) - Sep 17, 2022 - Abstract #ACRConvergence2022ACR_CONVERGENCE_3530; These results support and extend previous findings.No significant change in cell counts from week 0 to 16 when comparing treatment with 20mg BID of Lenabasum to placebo.Lenabasum significantly decreased phosphorylated interferon regulatory transcription factor 3 (pIRF3) and interferon gamma (IFNy) (p < 0.05) at 16 weeks compared to placebo. There was a trend towards a decrease in interleukin (IL) -31 (p=0.08).Subset analysis of subjects who received 20mg twice a day of Lenabasum showed that changes in the cutaneous dermatomyositis disease area and severity index activity (CDASI-A) score were positively correlated with change in the median pixel intensity in IL31.
- |||||||||| Benlysta (belimumab) / GSK, lenabasum (JBT-101) / Corbus Pharma, Kaken Pharma, Tasigna (nilotinib) / Novartis, Inhibikase
Changes in Skin Fibroblast Polarization Gene Expression Herald Clinical Improvement in Early, Diffuse Cutaneous Systemic Sclerosis (Room 121) - Sep 17, 2022 - Abstract #ACRConvergence2022ACR_CONVERGENCE_2403; These results validate previous findings that aSMA/CD34 polarization gene expression signatures decrease in patients with clinical improvement and suggest fibroblasts can recover, potentially by repopulating or differentiating, in the improving skin of patients with SSc.Figure 1. Change in aSMA/CD34 polarization genes expressed in skin from baseline to 52 weeks among individuals with diffuse cutaneous systemic sclerosis with and without 52-week clinical improvement.
- |||||||||| lenabasum (JBT-101) / Corbus Pharma, Kaken Pharma
Trial completion, Trial completion date: DETERMINE: Trial to Evaluate Efficacy and Safety of Lenabasum in Dermatomyositis (clinicaltrials.gov) - Aug 16, 2022 P3, N=176, Completed, Improvement in CDASI-A correlated with all PROMIS domains except physical function, though Skindex-29 demonstrated comparatively stronger p-values and better responsiveness to CDASI-A. Active, not recruiting --> Completed | Trial completion date: Sep 2022 --> Oct 2021
- |||||||||| lenabasum (JBT-101) / Corbus Pharma, Kaken Pharma
Journal: Lenabasum Reduces Porphyromonas gingivalis-Driven Inflammation. (Pubmed Central) - Jun 22, 2022 Tartrate-resistant acid phosphatase activity assay (TRAP) also demonstrated decreased osteoclastic activity in the treatment group compared to that in the controls. Lenabasum showed promising anti-inflammatory and pro-resolutive properties in the management of Pg-elicited inflammation, and thus, its potential as adjuvant periodontal treatment should be further investigated.
- |||||||||| lenabasum (JBT-101) / Corbus Pharma, Kaken Pharma
Efficacy and Safety of Lenabasum in the Phase 3 DeterMine Trial in Dermatomyositis (Auditorium 11) - Apr 4, 2022 - Abstract #EULAR2022EULAR_865; Although, primary or secondary endpoints were not met in the study, subgroup analysis of patients with muscle weakness and without muscle weakness, showed improvement in muscle strength and rash, respectively in lenabasum 20 mg BID group vs placebo. Lenabasum was administered safely and was well-tolerated in this study.
- |||||||||| EHP-101 / Emerald Health Pharmaceuticals, Aphios, Emerald Health Research
Preclinical, Journal: EHP-101 alleviates angiotensin II-induced fibrosis and inflammation in mice. (Pubmed Central) - Dec 25, 2021 EHP-101 is an oral lipidic formulation of the novel non-psychotropic cannabidiol aminoquinone VCE-004.8, which showed antifibrotic activity in murine models of systemic sclerosis induced by bleomycin...Mice infused with Ang II resulted in collagen accumulation in left ventricle, aortic, dermal, renal and pulmonary tissues; oral administration of EHP-101, Ajulemic acid and Losartan improved these phenotypes...Furthermore, EHP-101 inhibits renal, pulmonary and dermal fibrosis. EHP-101 could offer new opportunities in the treatment of cardiac fibrosis and other fibrotic diseases.
- |||||||||| lenabasum (JBT-101) / Corbus Pharma, Kaken Pharma
Trial completion: JBT-101 in Systemic Lupus Erythematosus (SLE) (clinicaltrials.gov) - Aug 9, 2021 P2, N=109, Completed, In future dcSSc trials that enroll subjects on bIST, statistical analyses should consider that subjects on placebo added to bIST are, in fact, receiving active concomitant treatment that will confound trial results over time. Active, not recruiting --> Completed
- |||||||||| lenabasum (JBT-101) / Corbus Pharma, Kaken Pharma
Trial primary completion date: DETERMINE: Trial to Evaluate Efficacy and Safety of Lenabasum in Dermatomyositis (clinicaltrials.gov) - Jun 16, 2021 P3, N=176, Active, not recruiting, The future challenges will be to customize patient-specific therapeutics with the goal to develop precision medicine for SSc. Trial primary completion date: Sep 2021 --> Mar 2021
- |||||||||| lenabasum (JBT-101) / Corbus Pharma, Kaken Pharma
Trial completion date, Trial termination: Safety, Tolerability, and Efficacy of JBT-101 in Subjects With Dermatomyositis (clinicaltrials.gov) - Apr 23, 2021 P2, N=22, Terminated, Trial completion date: May 2022 --> Dec 2020 | Active, not recruiting --> Terminated; Sponsor terminated open-label extension Trial completion date: Jul 2023 --> Jan 2021 | Active, not recruiting --> Terminated; Sponsor terminated open-label extension.
- |||||||||| lenabasum (JBT-101) / Corbus Pharma, Kaken Pharma
Trial completion date, Trial termination: Safety, Tolerability, Efficacy, and Pharmacokinetics of JBT-101 in Systemic Sclerosis (clinicaltrials.gov) - Apr 23, 2021 P2, N=42, Terminated, Trial completion date: Jul 2023 --> Jan 2021 | Active, not recruiting --> Terminated; Sponsor terminated open-label extension. Trial completion date: Dec 2021 --> Dec 2020 | Active, not recruiting --> Terminated; Sponsor terminated open-label extension
- |||||||||| lenabasum (JBT-101) / Corbus Pharma, Kaken Pharma
Journal: Lenabasum for Systemic Sclerosis - Are Cannabinoids the Missing Link? (Pubmed Central) - Apr 16, 2021 After many recent failed studies, we are excited to come across a positive drug trial in SSc. However, the systemic manifestations of the subjects i.e. pulmonary manifestations such as PH and ILD deserve a more detailed analysis, including their treatment response.
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