Corbus Pharmaceuticals Announces Presentation of Three Abstracts and New Lenabasum Data at 2019 ACR Annual Meeting

  • New lenabasum open-label extension study interim data in systemic sclerosis and dermatomyositis to be presented
  • Systemic sclerosis is a rare autoimmune disease affecting ~200,000 people in the U.S., EU and Japan and has the highest mortality rate among the systemic autoimmune diseases
  • Dermatomyositis is a rare systemic autoimmune disease affecting ~80,000 individuals in the U.S., EU and Japan and has a five-year mortality rate as high as 30%
  • Topline results from Phase 3 study of lenabasum for treatment of systemic sclerosis on target for summer of 2020 data readout
  • Corbus continues to be a pioneer in the development of transformative medicines that target the endocannabinoid system

Norwood, MA, Oct. 03, 2019 (GLOBE NEWSWIRE) -- Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) (“Corbus” or the “Company”), a clinical-stage drug development company pioneering transformative medicines that target the endocannabinoid system, announced the presentation of three abstracts at the American College of Rheumatology (“ACR”) 2019 Annual Meeting being held November 8-13, 2019 in Atlanta, Georgia.

Summarized below are the abstract titles that have been selected for oral or poster presentations. The ACR abstracts are available online at the conference website. Information from the ACR presentations are under embargo until November 9, 2019 at 4:30 p.m. ET. Once the posters are made public, they will be available on the Company’s website in the Scientific Conferences section.

Oral Presentations:

Abstract #865: Safety and Efficacy of Lenabasum at 21 Months in an Open-Label Extension of a Phase 2 Study in Diffuse Cutaneous Systemic Sclerosis Subjects
Date: Sunday, November 10, 2019
Session: 3S084: Systemic Sclerosis & Related Disorder – Clinical I: Therapeutics & Outcomes (863–868) (2:30 p.m. - 4:00 p.m. ET)
Presentation Time: 3:00 p.m. - 3:15 p.m. ET
Presenter: 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 study in systemic sclerosis

Abstract #2843: Safety and Efficacy of Lenabasum at Week 68 in an Open-Label Extension of a Phase 2 Study of Lenabasum in Refractory Skin-Predominant Dermatomyositis (DM) Subjects
Date: Tuesday, November 12, 2019
Session: 5T113: Muscle Biology, Myositis & Myopathies II (2840–2845) (4:30 p.m. - 6:00 p.m. ET)
Presentation Time: 5:15 p.m. - 5:30 p.m. ET
Presenter: Victoria Werth, M.D., Professor of Dermatology and Medicine at the University of Pennsylvania Perelman School of Medicine and Principal Investigator of Corbus' Phase 2 study in dermatomyositis


Abstract #720: Baseline Subject Demographics and Disease Characteristics in a Phase 3 Study of Safety and Efficacy of Lenabasum in Diffuse Cutaneous Systemic Sclerosis
Date: Sunday, November 10, 2019
Session: Systemic Sclerosis & Related Disorders – Clinical Poster I
Presentation Time: 9:00 a.m. - 11:00 a.m. ET
Presenter: 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 study in systemic sclerosis

About Lenabasum

Lenabasum is a rationally designed, oral, small molecule that selectively binds as an agonist to the cannabinoid receptor type 2 (CB2) and has been designed to resolve inflammation, limit fibrosis and support tissue repair. CB2 is preferentially expressed on activated immune cells and on fibroblasts, muscle cells, and endothelial cells. In both animal and human studies conducted to date, lenabasum has induced the production of pro-resolving lipid mediators that activate endogenous pathways which resolve inflammation and speed bacterial clearance without immunosuppression. Data from animal models and human clinical studies suggest that lenabasum can reduce expression of genes and proteins involved in inflammation and fibrosis. Lenabasum has demonstrated 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 acceptable safety and tolerability profiles in clinical studies to date. Lenabasum treatment was associated with improvement in multiple physician-assessed and patient-reported efficacy outcomes in Phase 2 studies in patients with diffuse cutaneous SSc and patients with DM with active skin involvement but not currently active muscle involvement. Lenabasum treatment also was associated with a lower rate of and longer time to pulmonary exacerbations in a Phase 2 cystic fibrosis study. Additional clinical studies are being conducted to confirm these results and support applications for regulatory approval.

About Corbus

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 pipeline of rationally designed, endocannabinoid system-targeting drug candidates. The Company's lead product candidate, lenabasum, is a novel, oral, selective cannabinoid receptor type 2 (CB2) agonist rationally designed to resolve chronic inflammation and fibrotic processes. Lenabasum is currently being evaluated in systemic sclerosis, cystic fibrosis, dermatomyositis and systemic lupus erythematosus.

Corbus is also developing a pipeline of drug candidates from more than 700 novel compounds targeting the endocannabinoid system. The pipeline includes CRB-4001, a 2nd generation, selective cannabinoid receptor type 1 (CB1) inverse agonist designed to be peripherally restricted. Potential indications for CRB-4001 include nonalcoholic steatohepatitis (NASH), among others. Corbus expects to initiate a Phase 1 study for CRB-4001 in 2019. We expect this to be followed by an NIH-funded study of blood brain barrier penetration by CRB-4001, then a biomarker study in people with metabolic syndrome or NASH.

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

Forward-Looking Statements

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.

Corbus Pharmaceuticals Contacts:

Ted Jenkins, Senior Director, Investor Relations and Corporate Communications
Phone: +1 (617) 415-7745

Lindsey Smith, Associate Director, Investor Relations and Corporate Communications
Phone: +1 (617) 415-7749

Jenene Thomas
Jenene Thomas Communications, LLC
Phone: +1 (833) 475-8247


Source: Corbus Pharmaceuticals Holdings, Inc.