According to a story from Central Charts, the biopharmaceutical company Inventiva recently announced the release of results from a Phase IIB clinical trial which tested the company’s lead product candidate, lanifibranor. The investigational drug was tested as a treatment for systemic sclerosis. Unfortunately, the drug failed to make a meaningful impact on the disease in comparison to placebo. Inventiva is committed to the development of small molecule drugs for a number of different indications, such as lysosomal storage diseases, fibrosis, and cancer.
About Systemic Sclerosis
Systemic sclerosis, which is also referred to as scleroderma, 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 sclerosis, click here.
About The Trial
This year long clinical trial, which involved a total of 145 patients with systemic sclerosis, saw patients receive either a 400mg or 600mg dose of lanifibranor twice per day alongside their standard therapy, which usually involved immune system suppressing drugs of some kind. Most patients were experiencing the early stages of their disease including skin abnormalities. The primary endpoint was changes in the thickness of patient’s skin (thickened skin is a common symptom of systemic sclerosis). Lanifibranor failed to produce any impact in this area and in secondary endpoints as well.
With the failure of this study, Inventiva will not longer continue to develop this drug as a treatment for systemic sclerosis. Lanifibranor is also being tested in another ongoing Phase IIB trial as a treatment for nonalcoholic steatohepatitis (NASH).