Corbus Pharmaceuticals Announces Patent Issuance Covering Use of Lenabasum for the Treatment of Fibrotic Diseases Providing Exclusivity to 2034
- Company’s vision is to become the leader in the treatment of inflammatory and fibrotic diseases by targeting the endocannabinoid system
- Intellectual property around pipeline targeting endocannabinoid system now covers lenabasum and CRB-4001
- Lenabasum is in late-stage clinical studies in three orphan indications with a combined 350,000 patients in the US, EU and Japan
- Latest patent issuance coupled with unencumbered commercial rights across all geographies increases strategic optionality
Norwood, MA, Oct. 03, 2018 (GLOBE NEWSWIRE) -- Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) (“Corbus” or the “Company”), a clinical stage drug development company with the industry’s leading pipeline focused on treating inflammatory and fibrotic diseases by targeting the endocannabinoid system, announced today that the U.S. Patent and Trademark Office (“USPTO”) 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. 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.
“The issuance of this third key patent reinforces lenabasum’s unique properties to treat diseases that typically have limited therapeutic options for patients,” said Mark Tepper, Ph.D., President and Chief Scientific Officer of Corbus. “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.”
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. 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 has demonstrated favorable safety and tolerability profiles in clinical studies to date. Lenabasum improved multiple physician-assessed and patient-reported efficacy outcomes in Phase 2 studies in patients with diffuse cutaneous SSc and skin-predominant dermatomyositis. Lenabasum also reduced pulmonary exacerbations in a Phase 2 cystic fibrosis study. Additional clinical studies are being conducted and/or planned to confirm these results and support applications for regulatory approval.
Corbus Pharmaceuticals Holdings, Inc. is a Phase 3 clinical-stage pharmaceutical company focused on the development and commercialization of novel therapeutics to treat inflammatory and fibrotic diseases by leveraging its industry leading pipeline of endocannabinoid system-targeting drug candidates. The Company's lead product candidate, lenabasum, is a novel, synthetic, oral, selective cannabinoid receptor type 2 (CB2) agonist designed to resolve chronic inflammation and fibrotic processes. Lenabasum is currently being evaluated in systemic sclerosis, cystic fibrosis, dermatomyositis, and systemic lupus erythematosus.
Corbus licensed the exclusive worldwide rights to develop, manufacture and market drug candidates from more than 600 novel compounds targeting the endocannabinoid system from Jenrin Discovery LLC. The pipeline includes CRB-4001, a 2nd generation, peripherally-restricted, selective cannabinoid receptor type 1 (CB1) inverse agonist specifically designed to eliminate blood-brain barrier penetration and brain CB1 receptor occupancy that mediate the neuropsychiatric issues associated with first-generation CB1 inverse agonists. Potential indications for CRB-4001 include NASH, primary biliary cholangitis, idiopathic pulmonary fibrosis, radiation-induced pulmonary fibrosis, myocardial fibrosis after myocardial infarction and acute interstitial nephritis, among others. CRB-4001 is scheduled to enter a Phase 1 study in 2019 followed a National Institutes of Health (NIH)-funded first-in-patient Phase 2 study.
This press release contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and Private Securities Litigation Reform Act, as amended, including those relating to the Company's product development, clinical and regulatory timelines, market opportunity, competitive position, possible or assumed future results of operations, business strategies, potential growth opportunities and other statement that are predictive in nature. These forward-looking statements are based on current expectations, estimates, forecasts and projections about the industry and markets in which we operate and management's current beliefs and assumptions.
These statements may be identified by the use of forward-looking expressions, including, but not limited to, "expect," "anticipate," "intend," "plan," "believe," "estimate," "potential, "predict," "project," "should," "would" and similar expressions and the negatives of those terms. These statements relate to future events or our financial performance and involve known and unknown risks, uncertainties, and other factors which may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Such factors include those set forth in the Company's filings with the Securities and Exchange Commission. Prospective investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this press release. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.
Source: Corbus Pharmaceuticals Holdings, Inc.
Investor Contacts: Institutional Investor Inquiries Ted Jenkins, Senior Director, Investor Relations and Communications Corbus Pharmaceuticals, Inc. Phone: +1 (617) 415-7745 Email: email@example.com All Other Investor Inquiries Jenene Thomas Jenene Thomas Communications, LLC Phone: +1 (833) 475-8247 Email: firstname.lastname@example.org Media Contact Eliza Schleifstein Scient Public Relations Phone: + 1 (917) 763-8106 Email: email@example.com
Released October 3, 2018