Phase 3 Clinical Trial for Systemic Scleroderma Resumes Recruiting Patients

According to a story from PR Newswire, the drug company CiVi Biopharma, Inc. today announced that its subsidiary Eicos Sciences, Inc. has resumed recruiting patients for its phase 3 clinical trial. This trial will investigate the company’s experimental treatment CIVI030 (intravenous iloprost) as a treatment for systemic scleroderma, a rare disease. CiVi is focused on developing novel treatments for diseases with unmet need.

About Systemic Scleroderma

Systemic scleroderma, which is also referred to as systemic sclerosis, describes a group of autoimmune diseases that can cause system-wide effects in the most severe cases. The mechanism of this disease is believed to be an autoimmune response in which the immune system mistakenly attacks body tissue. Some factors that may contribute to triggering the autoimmune response include mutations of the HLA genes and exposure to certain materials, such as certain solvents, white spirits, ketones, and silica. Symptoms are broad ranging and systemic, including kidney failure, erectile dysfunction, fatigue, stroke, headaches, facial pain, congestive heart failure, skin abnormalities, high blood pressure, chest pain, indigestion, and many more. Treatments are varied and depend on the symptoms, but most patients take medications in an attempt to suppress the autoimmune response. In severe cases, life expectancy is around 11 years from onset. To learn more about systemic scleroderma, click here.

About the Clinical Trial

This trial had previously halted operations because of the coronavirus/COVID-19 pandemic. The trial aims to include a total of 180 patients from 30 sites across the USA. Due to the delay, the company expects enrollment of these patients to conclude by the first quarter of next year. The patients will receive the drug for five days in a row in a six hour infusion. The study is specifically evaluating patients experiencing Raynaud’s phenomenon, or symptomatic digital ischemic episodes. These can trigger pain, discomfort, and other unusual sensations.

At this juncture, there is no FDA approved treatment specifically for systemic scleroderma. The effects of the disease can be debilitating as it progresses. CIVI030 could mean a significant treatment breakthrough if it is successful. The experimental drug has earned Orphan Drug designation from the FDA.

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