Type of information: Granting of a patent
Product name: lenabasum
Therapeutic area: Fibrotic diseases
- cannabinoid receptor agonist. Lenabasum is a rationally-designed, oral, small-molecule that selectively binds as an agonist to the cannabinoid receptor type 2 (CB2). CB2 is preferentially expressed on activated immune cells, fibroblasts, muscle cells, and endothelial cells.
- Lenabasum has been designed to resolve chronic inflammation and fibrosis through the activation of CB2 to stimulate production of specialized pro-resolving mediators, inhibition of pro-inflammatory mediators and tissue infiltration with inflammatory cells as well as cessation of fibrogenic processes.
- In both animal and human studies conducted to-date, lenabasum induces the production of Specialized Pro-resolving lipid Mediators (“SPMs”) that activate endogenous pathways which resolve inflammation and speed bacterial clearance without immunosuppression. Lenabasum also has a direct effect on fibroblasts to limit production of fibrogenic growth factors and extracellular connective tissue that lead to tissue fibrosis (scarring). Data from animal models and human clinical studies show lenabasum reduces expression of genes and proteins involved in inflammation and fibrosis. Lenabasum demonstrates promising activity in animal models of skin and lung inflammation and fibrosis in systemic sclerosis (SSc). Lenabasum is also active in animal models of lung infection and inflammation in cystic fibrosis and joint inflammation and scarring in rheumatoid arthritis. Lenabasum is a synthetic oral drug candidate designed to resolve chronic inflammation and fibrosis through the activation of CB2 to stimulate production of specialized pro-resolving mediators, inhibition of pro-inflammatory mediators and tissue infiltration with inflammatory cells as well as cessation of fibrogenic processes.
Company: Corbus Pharmaceuticals (USA - MA)
- • On October 3, 2018, Corbus Pharmaceuticals announced that the U.S. Patent and Trademark Office issued U.S. Patent No. 10,085,964 to the company. This patent includes claims covering the use of pharmaceutical compositions comprising lenabasum for the treatment of all fibrotic diseases, including Corbus’ lead indications systemic sclerosis, dermatomyositis, cystic fibrosis and others. The patent provides exclusivity in the U.S. for the use of lenabasum through 2034. This patent follows the previously issued U.S. Patent Nos. 9,801,849 and 9,820,964 covering uses of lenabasum in multiple inflammatory and fibrotic diseases, including systemic lupus erythematosus, multiple sclerosis, rheumatoid arthritis, psoriasis and others.
- This new patent is part of an expanding and comprehensive portfolio of patents, patent applications and other intellectual property covering the composition, synthesis, manufacturing, formulation and uses of lenabasum for the treatment of a variety of indications including the Company’s lead indications: systemic sclerosis, dermatomyositis, cystic fibrosis and systemic lupus erythematosus.
Submission of marketing authorization application USA :
Submission of marketing authorization application UE:
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
Favourable opinion UE:
Favourable opinion USA:
Orphan status USA:
Orphan status UE:
Pediatric exclusivit _USA:
Pediatric exclusivity UE: