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Nov. 9, 2020, 8:05 a.m. EST

Corbus Pharmaceuticals Presents Additional Data from RESOLVE-1 Study in Systemic Sclerosis

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Norwood, MA, Nov 09, 2020 (GLOBE NEWSWIRE via COMTEX) -- Corbus Pharmaceuticals Holdings, Inc. /zigman2/quotes/201549545/composite CRBP -0.53% ("Corbus" or the "Company"), a clinical-stage drug development company pioneering transformative medicines that target the endocannabinoid system, today presented additional data from the RESOLVE-1 Phase 3 study of lenabasum for the treatment of systemic sclerosis.

"We are encouraged by the post-hoc analyses pointing to lenabasum's therapeutic potential to reduce decline in lung function in people with systemic sclerosis who have been on longer-term immunosuppressant drug therapy," said Yuval Cohen, Ph.D., Chief Executive Officer of Corbus. "We believe these findings offer a rationale for additional clinical development of lenabasum, a non-immunosuppressive agent, that could address lung function decline in systemic sclerosis patients."

Summary of findings:

Modified intent-to-treat population (n = 363):

Placebo group (n = 123):

Post-hoc analyses of lenabasum 20 mg twice daily group compared to placebo group:

Safety findings:

The Company is continuing to analyze the data and will consider the potential for an additional study based on results of these analyses. Focusing on FVC in patients on established immunosuppressant therapies could address a key unmet need, and we believe represent a potential commercial opportunity.

Lenabasum has been granted Orphan Drug designation and Fast Track designation for the treatment of systemic sclerosis from the U.S. Food and Drug Administration ("FDA").

Study design:

RESOLVE-1 was a Phase 3 study evaluating the efficacy and safety of lenabasum in 365 people with diffuse cutaneous systemic sclerosis on background drug therapy in North America, Europe, Asia, Israel, and Australia. This was a double-blind, randomized, placebo-controlled study, with dosing of lenabasum at 20 mg twice daily, lenabasum at 5 mg twice daily, or placebo twice daily for 52 weeks. The primary efficacy endpoint was the median ACR CRISS scores at Week 52. For more information on RESOLVE-1, please visit ClinicalTrials.gov and reference Identifier: NCT03398837.

About Lenabasum

Lenabasum is a novel, oral, small molecule designed to provide an alternative to immunosuppressive treatments for inflammatory or fibrotic diseases. Lenabasum binds to and activates the cannabinoid receptor type 2 (CB2), which is preferentially expressed on activated immune cells, to resolve inflammation and limit fibrosis. Activity of lenabasum against inflammation and fibrosis has been demonstrated in animal and human models of disease. In clinical testing to date, lenabasum has an acceptable safety profile without evidence of immunosuppression, has not been associated with laboratory test abnormalities, and has been well-tolerated.

About Systemic Sclerosis

Systemic sclerosis is a form of the rare disease scleroderma in which internal organ involvement occurs. Systemic sclerosis is a chronic, debilitating autoimmune disease that affects approximately 200,000 people in the North America, EU and Japan.It is considered one of the most life-threatening rheumatic diseases. Disease pathology is characterized by inflammation and fibrosis (scarring of tissue) which can damage the skin, joints, tendons, gastrointestinal tract, lungs, heart, kidneys, and small blood vessels throughout the body. There is no cure for systemic sclerosis, and current treatments address the clinical manifestations of the disease.

About Corbus

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 designed to provide an alternative to immunosuppressive medications in the treatment of chronic inflammatory and fibrotic diseases. 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.

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