Corbus Pharmaceuticals has received a patent from the U.S. Patent and Trademark Office covering all compositions that comprise lenabasum and might be used to treat any fibrotic disease, including cystic fibrosis (CF), the company announced in a press release.
This patent (No. 10,085,964) also covers lenabasum in potentially treating dermatomyositis and systemic sclerosis. Previous patents for this investigational therapy pertain to its use in various inflammatory and fibrotic conditions.
Lenabasum (also known as anabasum, JBT-101, or resunab) is a synthetic oral small molecule being developed by Corbus that is aimed at resolving chronic inflammation by binding to a specific receptor (cannabinoid receptor type 2, CB2) on activated immune cells.
Mimicking the effects of endocannabinoids, a natural anti-inflammation mechanism, lenabasum is designed to block inflammation and prevent tissue scarring (fibrosis) without dampening the immune system.
Lenabasum was given orphan drug status as a potential CF treatment by the U.S. Food and Drug Administration (FDA) in 2015 and by the European Medicines Agency in 2016. The FDA also placed lenabasum on fast track to speed its development for CF.
In a Phase 2 study, supported by the Cystic Fibrosis Foundation Therapeutics, researchers evaluated the efficacy and safety of lenabasum in treating 85 CF patients. Data from this clinical trial (NCT02465450) reported a 75% reduction in pulmonary exacerbations (disease worsening) in patients given 20 mg of oral lenabasum twice daily compared with the placebo. Their lung function remained stable as well.
A multicenter Phase 2 trial (NCT03451045) to test the efficacy of lenabasum in 415 cystic fibrosis patients, ages 12 and older, is underway. Also supported by the Cystic Fibrosis Foundation, this international study is evaluating lenabasum’s effectiveness at two doses — 5 mg and 20 mg, twice daily — against a placebo in preventing disease worsening. Treatment will be given for about 28 weeks at sites across the U.S. and in Hungary, and eligible patients are still being recruited. More information is available here.
The company already holds two patents (9,801,849 and 9,820,964) covering lenabasum’s use in other fibrotic diseases and inflammatory conditions, such as rheumatoid arthritis, lupus, multiple sclerosis, chronic graft rejections, and others.
“The issuance of this third key patent reinforces lenabasum’s unique properties to treat diseases that typically have limited therapeutic options for patients,” Mark Tepper, PhD, president and chief scientific officer of Corbus, said in the release.
Corbus said in its release that the patents provide exclusivity in the U.S. for lenabasum’s potential use through 2034.