Corbus Extends US Patent Protection for Anabasum to Treat Systemic Sclerosis, Other Fibrotic Diseases
Issued by the U.S. Patent and Trademark Office, the mark gives Corbus protection in the United States until 2034. It adds to a patent issued last month that ensured protection for anabasum use to treat several inflammatory diseases.
“The issuance of this specific patent reaffirms the unique properties of anabasum to treat systemic sclerosis, dermatomyositis, cystic fibrosis and other rare fibrotic diseases for which there are limited therapeutic options for patients,” Dr. Mark Tepper, president and chief scientific officer of Corbus, said in a press release.
“The issuance of this second key patent this year is a reflection of our success in creating and expanding a robust intellectual property portfolio around anabasum,” added Dr. Yuval Cohen, CEO of Corbus.
Anabasum, formerly known as Resunab or JBT-101, is an engineered oral endocannabinoid-mimetic drug designed to have a dual action, targeting chronic inflammation and fibrosis at the same time.
The investigative compound binds to the cannabinoid receptor Type 2, or CB2, expressed in activated immune cells and fibroblasts. This triggers the production of specialized pro-resolving lipid mediators that inhibit pro-inflammatory and pro-fibrotic signals without blocking the immune cells’ primary function, which is to protect the body.
Preclinical and clinical studies have shown that anabasum is safe and well tolerated by patients.
Results from a Phase 2 clinical trial (NCT02465437)in patients with diffuse cutaneous systemic sclerosis have shown that anabasum can significantly reduce skin symptoms while modulating the expression of more than 1,940 genes involved in inflammation and fibrosis.
Recently announced data from six months of treatment showed that 20 mg of anabasum twice a day significantly reduced skin fibrosis, with 75 percent of treated patients improving at least five points in the modified Rodnan Skin Score (mRSS), a measure of skin thickness.
Anabasum-treated patients also improved their rheumatoid arthritis scores, as determined by the American College of Rheumatology’s diffuse cutaneous systemic sclerosis score (ACR CRISS).
Corbus plans to launch a Phase 3 study in patients with diffuse cutaneous systemic sclerosis. The new trial is expected to include about 270 participants, who will receive anabasum or placebo for up to 52 weeks.
Anabasum has received Orphan Drug Designation and Fast Track status by the U.S. Food and Drug Administration to treat systemic sclerosis. The investigative medicine has also received Orphan Designation from the European Medicines Agency.