Results of a Phase 2 clinical trial (NCT02465437) evaluating the effects of Corbus Pharmaceuticals’ anabasum (formerly known as Resunab or JBT-101) support this treatment as a potential option for patients with diffuse cutaneous systemic sclerosis.
The study showed that treatment with anabasum affects the activity of nearly 1,940 genes associated with different mechanisms, including molecules associated with inflammation, skin regulation and structure, and fat metabolism.
The study’s results were recently presented by Robert Spiera, MD, at the 2017 European League Against Rheumatism (EULAR) Annual Meeting held June 14-17 in Madrid, Spain, in an abstract titled “A Phase 2 study of the safety and efficacy of anabasum (JBT-101) in systemic sclerosis,” according to a press release.
The presentation included a review of the preliminary results obtained in the trial, as well as data from a study with patient-reported outcomes measurement information system (PROMIS)-29. Spiera also talked about the analysis of previously published results assessing the combined response index in the diffuse cutaneous systemic sclerosis (CRISS) score, a measure of improvement in systemic sclerosis.
The Phase 2 study investigating the effectiveness and safety of anabasum in systemic sclerosis also includes in its design an ongoing open-label extension study of 12 months. Results are expected to be known in late 2017.
Corbus Pharmaceuticals also plans to launch a Phase 3 study investigating anabasum in 270 systemic sclerosis patients later this year. This trial will have a double-blind, placebo-controlled design. Participants will be randomly assigned to receive either anabasum (5 mg or 20 mg twice a day) or a placebo for 52 weeks. Corbus expects that all patients will be enrolled by 2018 and the trial will be completed by late 2019.
In 2015, the U.S. Food and Drug Administration (FDA) granted orphan drug and fast track status to anabasum as a treatment for systemic sclerosis. And in January 2017, the drug was granted orphan drug status from the European Medicines Agency (EMA).
Anabasum is a synthetic oral drug with a safe and well-tolerated action that activates a group of proteins called CB2 receptors. When these receptors are expressed in activated immune cells, they trigger molecular pathways that improve inflammation and halt fibrosis.
The drug is also being tested in clinical trials as a potential treatment in patients with cystic fibrosis.