- Preliminary baseline subject demographics and disease characteristics in a Phase 3 clinical trial of the safety and efficacy of lenabasum in dermatomyositis (DETERMINE)
- Cannabinoid receptor type 2 expression is increased in lesional dermatomyositis skin compared to healthy skin and lenabasum significantly reduces CD8+ T cell expression of interferon γ
- Of the four systemic sclerosis subjects who developed COVID-19 infection while taking lenabasum during SSc OLE, only one subject required limited hospitalization
Norwood, MA, Oct. 21, 2020 (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, today announced the presentation of three abstracts at the American College of Rheumatology (“ACR”) Convergence 2020 being held online, November 5–9, 2020.
The full list of lenabasum presentations at ACR Convergence 2020 includes:
Abstract #1639: Preliminary Baseline Subject Demographics and Disease Characteristics in a Phase 3 Clinical Trial of the Safety and Efficacy of Lenabasum in Dermatomyositis (DETERMINE)
Session: Miscellaneous Rheumatic & Inflammatory Diseases Poster 3: Therapies
Date: Monday, November 9, 2020
Presentation Time: 9:00 a.m. - 11:00 a.m. ET
Presenter: Victoria Werth, M.D., Professor of Dermatology and Medicine at the University of Pennsylvania Perelman School of Medicine and Co-Principal Investigator of Corbus' Phase 3 DETERMINE study in dermatomyositis
Abstract #1949: CB2 Receptor Distribution and Effects of Lenabasum in Dermatomyositis In Vitro
Session: Cytokines & Cell Trafficking (1948–1952)
Date: Monday, November 9, 2020
Presentation Time: 3:00 p.m. - 3:50 p.m. ET
Presenter: Spandana Maddukuri, University of Pennsylvania and the Michael J. Crescenz VA Medical Center
Abstract # 1379: Clinical Outcomes Among Participants with Diffuse Systemic Sclerosis Contracting COVID-19 During Clinical Studies of Lenabasum: A Case Series
Session: Systemic Sclerosis & Related Disorders – Clinical Poster 3
Date: Sunday, November 8, 2020
Presentation Time: 9:00 a.m. - 11:00 a.m. ET
Presenter: Robyn Domsic, M.D., MPH, Associate Professor of Medicine in the Division of Rheumatology and Clinical Immunology at the University of Pittsburgh School of Medicine and investigator of Corbus’ Phase 3 RESOLVE-1 study in systemic sclerosis
The ACR abstracts are available online at the conference website. Information from the ACR presentations are under embargo until November 5, 2020 at 2:00 p.m. ET. Once the posters are made public, they will be available on the Company’s website in the Scientific Conferences section.
Lenabasum is a novel, oral, small molecule that selectively binds as an agonist to the cannabinoid receptor type 2 (CB2) and resolves inflammation and limits fibrosis in animal and human models of disease. CB2 is preferentially expressed on activated immune cells and on fibroblasts, muscle cells, and endothelial cells. Lenabasum has demonstrated acceptable safety and tolerability profiles in clinical studies to date.
Dermatomyositis (DM), a form of myositis, is a chronic, rare, inflammatory, clinically heterogenous, life-threatening autoimmune disease affecting approximately 80,000 people in North America, EU and Japan.1 The signs and symptoms of DM reflect multi-organ involvement, which includes distinctive skin rashes usually accompanied by proximal muscle weakness, and can also include pulmonary, cardiac, gastrointestinal, and joint involvement.2 Patients with DM can have recurrent disease flares or chronic progressive disease activity, with increased mortality.3,4 The current mainstay of treatments include FDA-approved systemic glucocorticoids, adrenocorticotropic hormone analogue and off-label use of glucocorticoid-sparing immunosuppressive agents.5,6 There is significant unmet need for new treatments to achieve disease control in DM because of limited efficacy or toxicity of immunosuppressive agents or refractory disease.7,8
About Systemic Sclerosis
Systemic sclerosis, a form of scleroderma, is a chronic, rare, debilitating autoimmune disease affecting approximately 200,000 people in the North America, EU and Japan.1 Systemic sclerosis is considered one of the most life-threatening rheumatic diseases.9 The disease affects the skin and internal organs and is driven by inflammation and fibrosis (scarring of tissue) which can lead to severe damage and failure of multiple organs including the skin, joints, tendons, gastrointestinal tract, lungs, heart, blood vessels and kidneys.10 There is no cure for systemic sclerosis, and current treatments address the clinical manifestations of the disease, not the underlying mechanisms that drive inflammation and fibrosis.11
Corbus Pharmaceuticals Holdings, Inc. is a clinical-stage company focused on the development and commercialization of novel medicines designed to target the endocannabinoid system. The Company’s lead product candidate, lenabasum, is a novel, oral, selective cannabinoid receptor type 2 (CB2) agonist that resolves chronic inflammation and limits fibrosis in animal and human models. Lenabasum is currently being evaluated in dermatomyositis and systemic lupus erythematosus. Corbus is also developing a pipeline of other preclinical drug candidates from its endocannabinoid system platform.
Lenabasum is not approved for the treatment of any indication. For more information on Corbus’ clinical programs, please visit here.
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 restructuring, trial results, 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, including the potential impact of the recent COVID-19 pandemic and the potential impact of sustained social distancing efforts, on our operations, clinical development plans and timelines, 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:
- Health Advances, LLC Analysis
- “Dermatomyositis Information Page.” National Institute of Neurological Disorders and Stroke, U.S. Department of Health and Human Services, 29 September 2020, www.ninds.nih.gov/Disorders/All-Disorders/Dermatomyositis-Information-Page
- Marie, Isabelle. “Morbidity and Mortality in Adult Polymyositis and Dermatomyositis.” Current Rheumatology Reports, vol. 14, no. 3, 2012, pp. 275–285., doi:10.1007/s11926-012-0249-3
- Schiopu, Elena, et al. “Predictors of Survival in a Cohort of Patients with Polymyositis and Dermatomyositis: Effect of Corticosteroids, Methotrexate and Azathioprine.” Arthritis Research & Therapy, vol. 14, no. 1, 2012, doi:10.1186/ar3704
- FDA label Orapred ODT, availableat https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021959s004lbl.pdf; accessed 29 September 2020
- FDA label H.P. Acthar gel, available at https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/008372s057lbl.pdf; accessed 29 September 2020
- Dalakas, Marinos C. “Immunotherapy of Myositis: Issues, Concerns and Future Prospects.” Nature Reviews Rheumatology, vol. 6, no. 3, Mar. 2010, pp. 129–137., doi:10.1038/nrrheum.2010.2
- DeWane ME, et al. Dermatomyositis: Clinical features and pathogenesis. J Am Acad Dermatol.
- Elhai M, Meune C, Avouac J, Kahan A, Allanore Y. Trends in mortality in patients with systemic sclerosis over 40 years: a systematic review and meta-analysis of cohort studies. Rheumatology 2012;51(6):1017e26
- Sierra-Sepulveda A, Esquinca-Gonzalez A, Benavides-Suarez SA, Sordo-Lima DE, Caballero-Islas AE, Cabral-Castaneda AR, et al. Systemic Sclerosis Pathogenesis and Emerging Therapies, beyond the Fibroblast. Biomed Res Int. 2019;2019:4569826
- Scleroderma.” National Institute of Arthritis and Musculoskeletal and Skin Diseases, U.S. Department of Health and Human Services, 29 September 2020, www.niams.nih.gov/health-topics/scleroderma/advanced#tab-risk.