Corbus Pharmaceuticals Presents 1-Year Systemic Sclerosis and 6-Month Dermatomyositis Data from Open-Label Extension of Phase 2 Lenabasum Studies at EULAR 2018

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Norwood, MA, June 13, 2018 (GLOBE NEWSWIRE) -- Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) ("Corbus" or the "Company"), a Phase 3 clinical-stage pharmaceutical company focused on the development and commercialization of novel therapeutics to treat rare, chronic and serious inflammatory and fibrotic diseases, announced today that data from open-label extensions (OLEs) of its systemic sclerosis (SSc) and dermatomyositis (DM) Phase 2 studies  are being presented at the Annual European Congress of Rheumatology (EULAR 2018).

Key highlights from the data being presented include:

“We now have long-term safety and efficacy data in two related, rare and serious autoimmune diseases, SSc and DM,” stated.  “I believe that the favorable safety profile and the consistency and magnitude of changes in efficacy outcomes affirm a durability of treatment effect for lenabasum and show a cross-substantiation of data between the two studies. The degree of improvement in mRSS and CRISS scores in the SSc study, and in CDASI activity scores in the DM study are considerable, increased over time, and strengthen our confidence that lenabasum could offer benefit to patients with these diseases.”

The abstract entitled, “ (Abstract #3512) was presented in an oral presentation by Robert Spiera, M.D., Director of the Vasculitis and Scleroderma Program at the Hospital for Special Surgery, Weill Cornell Medical College in New York City and Principal Investigator of the Phase 2 and Phase 3 trials in SSc. To access the presentation, click .

The ACR Composite Response Index in diffuse cutaneous Systemic Sclerosis score (ACR CRISS) increased steadily with lenabasum treatment and reached 92% (median), with 50% of subjects achieving a score 95% at 1 year. ACR CRISS is a measure of improvement in systemic sclerosis which is based on an exponentially weighted algorithm of change from baseline that includes the mRSS as well as physician and patient assessments and forced vital capacity (FVC). Patient-reported disability, function, skin symptoms and global health all improved from study start and OLE start.

The mRSS and ACR CRISS, responses exceeded those seen in the 16-week double-blind placebo-controlled phase and the 6-month time point in the OLE.

Lenabasum has been granted and status for the treatment of SSc from the FDA and from the EMA. Lenabasum is currently being evaluated in the international multicenter Phase 3 RESOLVE-1 study, a double-blind, randomized, placebo-controlled study assessing the efficacy and safety for the treatment of diffuse cutaneous SSc.

The abstracts entitled, “ (Abstract #3531) and “,” (Abstract #5629) will be presented in poster presentations by Victoria Werth, M.D., Professor of Dermatology and Medicine at the University of Pennsylvania School of Medicine and Principal Investigator in the Phase 2 study. To access the poster, click .

The DM Phase 2 study was funded by a grant from the National Institute of Arthritis and Musculoskeletal and Skin Diseases of the National Institutes of Health to the University of Pennsylvania Perelman School of Medicine. For more information about the Phase 2 study in dermatomyositis, please visit and reference identifier NCT02466243.

Dermatomyositis is a rare and serious systemic autoimmune condition characterized by skin and muscle involvement. Like other autoimmune diseases, it affects more women than men and morbidity is more severe in black, Asian and Native American populations. The disease is characterized by distinct skin lesions that can be accompanied by erosions, photosensitivity, itch, ulcers, calcinosis and hair loss as well as other abnormalities. Muscle inflammation and atrophy is a characteristic of the disease and can manifest as weakness. Dermatomyositis affects as many as 70,000 people in the US. Mortality is high with 5-year survival of 70% and 10-year survival of 57%. Standard of care includes antimalarial drugs and potent immunosuppressive agents, which often lead to significant adverse effects.

Lenabasum (formerly known as anabasum) is a synthetic, oral, small-molecule, selective cannabinoid receptor type 2 (CB2) agonist that preferentially binds to CB2 expressed on activated immune cells and fibroblasts. CB2 activation triggers physiologic pathways that resolve inflammation, speed bacterial clearance and halt fibrosis. CB2 activation also induces the production of specialized pro-resolving lipid mediators that activate an endogenous cascade responsible for the resolution of inflammation and fibrosis, while reducing production of multiple inflammatory mediators. Through activation of CB2, lenabasum also is designed to have a direct effect on fibroblasts to halt tissue scarring. Lenabasum is believed to induce resolution rather than immunosuppression by triggering biological pathways to turn "off" chronic inflammation and fibrotic processes. Lenabasum has demonstrated promising potency in preclinical models of inflammation and fibrosis. Preclinical and human clinical studies have shown lenabasum to have a favorable safety, tolerability and pharmacokinetic profile. Further, the drug has demonstrated clinical benefit and positive impact on inflammatory and immunological markers in Phase 2 studies in diffuse cutaneous systemic sclerosis, dermatomyositis and cystic fibrosis.

Corbus Pharmaceuticals Holdings, Inc. is a Phase 3 clinical-stage pharmaceutical company focused on the development and commercialization of novel therapeutics to treat rare, chronic, and serious inflammatory and fibrotic diseases. The Company's lead product candidate, lenabasum, is a novel, synthetic oral endocannabinoid-mimetic drug designed to resolve chronic inflammation and fibrotic processes. Lenabasum is currently being evaluated in systemic sclerosis, cystic fibrosis, dermatomyositis, and systemic lupus erythematosus.

For more information, please visit and connect with the Company on , , and .

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.

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Globe Newswire: 14:29 GMT Wednesday 13th June 2018

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