The new patent (No. 9,801,849), issued by the U.S. Patent and Trademark Office, protects the use of anabasum for the treatment of systemic sclerosis, dermatomyositis, cystic fibrosis and systemic lupus erythematosus in the United States until 2034.
Anabasum, formerly known as Resunab or JBT-101, is an engineered oral endocannabinoid-mimetic drug designed to target chronic inflammation and fibrosis.
The investigative compound binds to the cannabinoid receptor Type 2, or CB2, expressed in activated immune cells. This triggers production of specialized pro-resolving lipid mediators that can inhibit pro-inflammatory and pro-fibrotic cellular signals without blocking the immune cells’ primary function, which is to protect the body.
“The issuance of this patent is significant in that it reinforces our intellectual property strategy based on the unique properties of anabasum to activate CB2 leading to the production of Specialized Pro-resolving lipid Mediators,” Mark Tepper, president and CEO of Corbus, said in a press release.
Preclinical and clinical studies show that treatment with anabasum is safe and well tolerated.
A Phase 2 (NCT02465437) clinical trial in diffuse cutaneous systemic sclerosis has demonstrated that anabasum can significantly reduce skin symptoms while modulating the expression of more than 1,940 genes involved in inflammation and fibrosis.
Later this year, Corbus plans to launch a Phase 3 study in patients with diffuse cutaneous systemic sclerosis. Designed with help from the European Medicines Agency, the trial will likely enroll about 270 patients who will be randomly designated to receive anabasum 20 mg or 5 mg twice daily, or placebo, for up to 52 weeks.
“The expansion of our intellectual property portfolio is an integral aspect of Corbus’ clinical development and commercialization strategy aimed at positioning anabasum as a first-in-class therapy targeting multiple rare inflammatory-fibrotic diseases with clear unmet needs and significant morbidity and mortality,” said Corbus CEO Yuval Cohen.
If the trials are successful, Corbus expects to file marketing applications with regulatory agencies to approve anabasum as a systemic sclerosis treatment by 2020.