Date: 2017-12-22
Type of
information: Initiation of the trial
phase: 2
Announcement: initiation of the trial
Company: Corbus Pharmaceuticals (USA - MA)
Product: anabasum (JBT-101 )
Action
mechanism:
- cannabinoid receptor agonist. Anabasum is a synthetic, oral, small-molecule, selective cannabinoid receptor type 2 (CB2) agonist that preferentially binds to CB2 expressed on activated immune cells and fibroblasts. CB2 activation triggers physiologic pathways that resolve inflammation, speed bacterial clearance and halt fibrosis. CB2 activation also induces the production of specialized pro-resolving lipid mediators that activate an endogenous cascade responsible for the resolution of inflammation and fibrosis, while reducing production of multiple inflammatory mediators.
- Through activation of CB2, anabasum also is designed to have a direct effect on fibroblasts to halt tissue scarring. Anabasum is believed to induce resolution rather than immunosuppression by triggering biological pathways to turn "off" chronic inflammation and fibrotic processes. Anabasum has demonstrated promising potency in preclinical models of inflammation and fibrosis. Preclinical and human clinical studies have shown anabasum to have a favorable safety, tolerability and pharmacokinetic profile.
Disease: systemic lupus erythematosus (SLE)
Therapeutic
area: Autoimmune diseases
Country: USA
Trial
details:
- One hundred adults with active joint disease and at least moderate pain will be enrolled in this study to evaluate JBT-101, a synthetic endocannabinoid receptor type 2 (CB2) agonist and an activator of the body's normal processes, to resolve innate immune responses without immunosuppression.
- Participants will receive 2 doses by mouth of JBT-101 (three groups of varying doses) or placebo for 84 days and will continue to be followed for an additional 28 days. Participant visits to assess endpoints occur on Day 1, then every 2 weeks twice, then every 4 weeks three times, for a total of six visits. The change in maximum daily pain Numerical Rating Scale (NRS) score from Baseline (Visit 1) will be assessed at every visit. Studies are also planned to evaluate tolerability and inflammation. (NCT03093402)
Latest
news:
- • On December 22, 2017, Corbus Pharmaceuticals announced the initiation of a Phase 2 clinical study of anabasum for the treatment of systemic lupus erythematosus. This clinical trial is being conducted by the Autoimmunity Centers of Excellence (ACE) program, which is funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). Cynthia Aranow, M.D., of the Feinstein Institute for Medical Research (FIMR), Manhasset, NY, is Principal Investigator for ACE, and Meggan Mackay, M.D., M.S., is Principal Investigator for the clinical trial of anabasum in SLE. Drs. Aranow and Mackay are Investigators at the Center for Autoimmunity & Musculoskeletal Disease at FIMR and Associate Professors of Molecular Medicine at Hofstra Northwell School of Medicine.
- The randomized, double-blind, placebo-controlled, Phase 2 trial will be conducted at 15 sites in the United States and will enroll 100 adult SLE patients with active musculoskeletal disease, which is the most common disease manifestation of SLE. Subjects will be randomized in a 1:1:1:1 ratio to one of four cohorts to receive placebo or three different doses of anabasum for 3 months, with 1-month follow-up. The primary efficacy outcome assesses pain from active musculoskeletal disease, and secondary efficacy outcomes include other assessments of active musculoskeletal disease, overall disease activity using SLE Responder Index, SLE Disease Activity Index ("SLEDAI") and British Isles Lupus Activity Group ("BILAG") scoring systems, and patient-reported outcomes.
Is
general: Yes
