The U.S. Patent and Trademark Office (USPTO) has issued a new patent to Corbus Pharmaceuticals to cover the use of investigational lenabasum-based therapies for the treatment of fibrotic diseases, including scleroderma.
The patent, No. 10,085,964, provides the company exclusive rights for the use of lenabasum-based pharmaceutical compositions within the United States until 2034.
The new patent follows previously issued patents granting rights over the use of lenabasum in several autoimmune, inflammatory, and fibrotic diseases, such as systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, cystic fibrosis, 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 at Corbus, said in a press release.
“This newly issued patent, along with the previously issued U.S. patent Nos. 9,801,849 and 9,820,964, provides Corbus with broad and long-term intellectual property rights to lenabasum through 2034,” Tepper added.
The new patent adds to Corbus’ expanding portfolio of patents, patent applications, and other intellectual property protecting the composition, synthesis, manufacturing, formulation, and applications of lenabasum.
Lenabasum is an oral, small molecule that binds and triggers the activity of the cannabinoid receptor type 2 (CB2), a protein present in activated immune cells (which are overactive in autoimmune disorders), fibroblasts (cells that when dysregulated may trigger fibrotic diseases), muscle cells, and endothelial cells (the cells lining the inner part of blood vessels).
Lenabasum activates CB2, thus promoting the production of specialized pro-resolving lipid mediators — fat molecules that activate cellular pathways involved in reducing inflammation and speeding bacterial killing without compromising the immune system. The drug also limits the production of fibrosis-inducing proteins in fibroblasts.
Preclinical and clinical studies have demonstrated lenabasum’s capacity to decrease the expression of genes and proteins involved in inflammation. The molecule showed promising results in animal models of skin and lung fibrosis, as well as inflammation.
A Phase 2 clinical trial (NCT02465437) investigating the safety, tolerability, efficacy and pharmacokinetics of lenabasum in patients with diffuse cutaneous scleroderma reported the improvement of multiple physician- and patient-assessed efficacy outcomes.
Other clinical trials testing lenabasum for the treatment of dermatomyositis and cystic fibrosis also showed positive data.
Additional studies are being planned and/or conducted to confirm these results so Corbus can apply for regulatory approval of lenabasum.
The company is currently recruiting patients with diffuse cutaneous scleroderma for the Phase 3 RESOLVE-1 trial (NCT03398837) assessing the efficacy and safety of lenabasum. An estimated 354 patients are expected to be enrolled in the study at some 60 sites in North America, Europe, Australia and Asia.