Anabasum (formerly known as Resunab and JBT-101) is a synthetic, oral endocannabinoid-mimetic drug currently being developed by Corbus Pharmaceuticals for inflammation. The drug is believed to increase the production of anti-inflammatory mediators while reducing the production of those that increase inflammation. Reducing inflammation could help prevent permanent tissue damage in the lungs of people with cystic fibrosis (CF).
How anabasum for CF works
Anabasum is a synthetic oral drug that mimics the effects of endocannabinoids. The drug was designed to trigger the production of specialized pro-resolving lipid mediators that activate an endogenous cascade responsible for resolving inflammation and halting fibrosis, while reducing production of inflammatory mediators. The therapy is designed to do this without causing immunosuppression.
Preclinical and early clinical studies involving anabasum showed a favorable safety, tolerability, and pharmacokinetic profile (how a drug is processed in the body, including its distribution, metabolism, and excretion). In preclinical models of inflammation and fibrosis, it stopped tissue scarring, essentially “turning off” chronic inflammation and fibrotic processes.
A double-blind, randomized, and placebo-controlled Phase 2 study is currently ongoing but not recruiting participants (NCT02465450). It is evaluating the safety, tolerability, pharmacokinetics, and effectiveness of multiple doses of anabasum compared to placebo in 85 adults with CF, as well as its impact on the bacterial load in the lungs and on inflammation biomarkers in the sputum and blood.
The company recently announced top-line results from the trial showing that the primary objective was achieved with an acceptable safety and tolerability profile for the drug at all doses with no serious or severe adverse events. A dose-dependent reduction in multiple lung inflammatory cells and mediators was observed and a clinical benefit in acute pulmonary exacerbations was recorded. According to the company, the data supports further clinical development of the drug.
Anabasum has been designated an Orphan Drug for the treatment of cystic fibrosis in the U.S. and in Europe; the U.S. Food and Drug Administration (FDA) also granted it Fast Track status to speed its development for the possible treatment of CF.
The drug is also being tested in Phase 2 clinical trials as a possible treatment for other diseases such as scleroderma, dermatomyositis, and systemic lupus erythematosus (SLE), in which inflammation is also linked to disease progression.
On April 5, 2017, Corbus announced it will proceed with a single Phase 3 study to support a New Drug Application (NDA) for anabasum for the treatment of diffuse cutaneous systemic sclerosis.
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