电竞之家_品味电竞生活移动版

There were no severe or serious AEs and no clinically significant laboratory abnormalities related to the drug. Thirty-three (92%) subjects experienced AEs, and 7 (19%) subjects experienced AEs related to lenabasum during open-label dosing. AEs that occurred in 10% of subjects (n, %) were upper respiratory tract infection (8, 22%), arthralgia, skin ulcer, and urinary tract infection (5, 13.9% each), and diarrhea (4, 11.1%).

Lenabasum has been grantedOrphan Drug DesignationandFast Trackstatus for the treatment of SSc from the FDA andOrphan Designationfrom 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.

Dermatomyositis Poster Presentation Overview

The abstracts entitled, A Phase 2 Study of Safety and Efficacy of Lenabasum (JBT-101), A Cannabinoid Receptor Type 2 Agonist, In Refractory Skin-Predominant Dermatomyositis,(Abstract #3531) and Safety and Efficacy of Lenabasum In Refractory Skin-Predominant Dermatomyositis Subjects Treated in An Open Label Extension of Trial JBT101-DM-001, (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, clickhere.

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 visitClinicalTrials.govand reference identifier NCT02466243.

Study Design

Twenty subjects with refractory, skin-predominant DM received open-label dosing with lenabasum at 20 mg twice per day following 16-weeks participation in the preceding double-blinded placebo-controlled part of the lenabasum Phase 2 study. There was a mean 31-week wash-out off investigational product prior to the start of the OLE. Seventeen subjects completed 6-months (28-weeks) follow-up in the OLE at the time of data-cut. Lenabasum treatment was in addition to standard-of-care treatments for DM, including stable doses of concomitant immunosuppressive drugs in 91% of subjects.

Efficacy Outcomes

At 6 months (28 weeks), the CDASI activity score improved by a mean of -15.4 points from baseline at the start of the Phase 2 double-blind, placebo-controlled phase of the study. The baseline CDASI activity score at study start was 35 points. At 6 months, 88% of subjects achieved reduction 5 points, which is considered medically meaningful, 82% achieved reduction 10 points, and 47% had achieved a low CDASI activity score ( 14 points). Patient-reported global disease activity, global skin disease, function, pain, and skin symptoms all improved from study start and OLE start, as did physician global disease and skin activity assessments.

Safety

There were no severe or serious AEs and no clinically significant laboratory abnormalities related to the drug. Thirteen (65%) subjects experienced AEs, and 5 (25%) subjects experienced AEs related to lenabasum during open-label dosing. A DM flare, which is an episode of worsening of the disease, was the only AE that occurred in 2 subjects, occurring in 2 subjects (one of which experienced a reduction of 14 points in CDASI activity from study start and another of which experienced an increase of 5 points from study start).

About Systemic Sclerosis

Systemic sclerosis is a rare and serious systemic autoimmune rheumatic disease with an unclear etiology. Systemic sclerosis affects approximately 90,000 people in the United States and Europe, with disease onset typically in mid-life. About 80 percent of SSc patients are women. The disease process in systemic sclerosis includes activation of the immune system, with damage to small blood vessels and fibrosis of the skin on internal organs, including lungs, heart, kidneys, gastrointestinal tract and musculoskeletal system. Chronic disease burden, morbidity and mortality are significant. Ten-year mortality rates are high at about 40-60%. Cardiopulmonary disease is the major cause of death in SSc. Immunosuppressive medications such as oral corticosteroids, mycophenolate, methotrexate and cyclophosphamide are used to treat patients with more severe signs and symptoms of disease. Currently, there are no FDA-approved treatments specifically indicated for the treatment of systemic sclerosis, other than pulmonary artery hypertension secondary to connective tissue diseases such as systemic sclerosis.

About Dermatomyositis

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.

About Lenabasum