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Corbus Pharmaceuticals Announces Topline Results From RESOLVE-1 Phase 3 Study Of Lenabasum; Says Data Showed 'no significant differences in the primary and secondary endpoints when comparing lenabasum to placebo, both added to background drug therapy.'

Topline data showed nosignificant differences in the primary and secondary endpoints when comparing lenabasum to placebo, both added to backgrounddrug therapy Unprecedented improvement was observed in subjects on

· 09/08/2020 07:08
  • Topline data showed nosignificant differences in the primary and secondary endpoints when comparing lenabasum to placebo, both added to backgrounddrug therapy
  • Unprecedented improvement was observed in subjects on placebo added to background drug therapy, achieving median ACR CRISS score of 0.887
  • 84% of enrolled subjects were receiving background immunosuppressive drugs, reflecting recent trends in clinical practice
  • Lenabasum treatment was safe and well-tolerated in this study with no new safety signals observed
  • Further analyses of data are underway, and results will be presented at upcoming medical conferences
  • Lenabasum clinical trials in cystic fibrosis, dermatomyositis and systemic lupus erythematosus are ongoing
  • Company to host conference call and webcast today, September 8, 2020 at 8:30 a.m. ET

Norwood, MA, Sept. 08, 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 topline results from the 52-week Phase 3 RESOLVE-1 study of lenabasum in patients with diffuse cutaneous systemic sclerosis (SSc). SSc isa rare and life-threatening multi-system autoimmune disease for which there are currently no U.S. Food and Drug Administration (FDA)-approved treatments for overall disease.

Topline data showed no significant differences in the primary and secondary endpoints when comparing lenabasum to placebo, both added to background drug therapy.

For the primary endpoint, the median American College of Rheumatology Combined Response Index for Systemic Sclerosis (ACR CRISS) scores at Week 52 were 0.887 in the placebo arm and 0.888 in the lenabasum 20 mg twice daily arm. ACR CRISS is a composite endpoint that reflects the probability of patient improvement. The maximum achievable ACR CRISS score is 1.0.

RESOLVE-1 is the first 52-week, randomized, placebo-controlled Phase 3 trial that tested the efficacy and safety of lenabasum in 365 patients with diffuse cutaneous SSc in a multinational, 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 majority of enrolled patients (84%) were receiving background immunosuppressive drugs, reflecting recent trends in clinical practice.

Similar proportions of placebo-treated and lenabasum-treated subjects had at least one treatment emergent adverse event (AEs), 86.2% in the placebo arm and 91.7% in the lenabasum 20 mg twice daily arm. Serious AEs occurred in 14.6% of subjects in the control arm and 9.2% of subjects in the lenabasum 20 mg twice daily arm. Severe AEs occurred in 13% of subjects in the control arm and 5.8% of subjects in the lenabasum arm. No subjects receiving lenabasum withdrew from the study because of an AE-related to study drug. Lenabasum treatment was well-tolerated in this study. No evidence of lenabasum-related immunosuppression or new safety signals for lenabasum were observed.

Further analyses of these data are underway, and once Corbus has a fuller understanding of the data, the Company would like to engage with the FDA to determine potential next steps in this clinical development program. The data will be presented at upcoming medical conferences.

Yuval Cohen, Ph.D., Chief Executive Officer of Corbus said, "We are surprised and deeply disappointed that the RESOLVE-1 trial did not meet its primary endpoint. I would like to extend my gratitude to the participants in the study and the clinical staff at the study sites, as well as to the Corbus employees, for their hard work and dedication. We now look forward to upcoming topline results from our study of lenabasum in patients with cystic fibrosis."

RobertSpiera, M.D., Co-Principal Investigator on RESOLVE-1 and Director of the Scleroderma, Vasculitis, and Myositis Program at the Hospital for Special Surgery, Weill Cornell Medical College in New York City said, "I am genuinely surprised by these results. Immunosuppressive drugs, alone or in combination, are increasingly becoming a mainstay of treatment for patients with early diffuse cutaneous SSc. However, the impact of these drugs on disease has not previously been studied systematically and clearly was underappreciated by the community of SSc experts. The high degree of efficacy of background drug therapy in the control arm is well beyond what was expected."

Professor Christopher Denton, PhD, FRCP, Co-Principal Investigator on RESOLVE-1 and Professor of Experimental Rheumatology at UCL Medical School and Consultant Rheumatologist and Joint Director of the Centre for Rheumatology, Royal Free Hospital, London said, "Whilst the immediate study results are disappointing, RESOLVE-1 provides a rich dataset to understand for the first time how to better target treatments for SSc based upon clinical parameters and concomitant treatment. We are already querying the data to understand the natural history of early diffuse cutaneous SSc and the potential benefits of lenabasum in these subjects. Despite the efficacy of current immunosuppressive treatments in early diffuse cutaneous systemic sclerosis, there is still major unmet need in this patient group. The potential value of a non-immunosuppressive treatment, added-to or used instead of, additional immunosuppressive medications, remains exciting. The safety profile and tolerability of lenabasum is very attractive for use in SSc patients."

Barbara White, M.D., Chief Medical Officer and Head of Research of Corbus commented, "We will now focus on further analyses of the data to potentially identify groups of patients that may have responded to lenabasum."

Lenabasum was granted Orphan Drug designation and Fast Track designation for the treatment of SSc from the FDA and Orphan Designation for the treatment of SSc from the European Medicines Agency.

Lenabasum is currently being evaluated in a Phase 3 DETERMINE study in dermatomyositis, a Phase 2 study in systemic lupus erythematosus, and a Phase 2b study in cystic fibrosis.