Liver Institute Northwest is enrolling participants into RESPONSE, a global phase 3 clinical research study evaluating the safety and efficacy of seladelpar, an investigational drug for people already diagnosed with PBC who have been using ursodeoxycholic acid (also known as UDCA or ursodiol) but have not achieved the recommended treatment goal or cannot tolerate UDCA. PBC is a chronic, serious and potentially life-threatening liver disease.
Seladelpar (study drug) is a potent, selective, orally active peroxisome proliferator-activated receptor delta (PPARδ) agonist in development for the treatment of people with PBC and other liver diseases. It controls metabolic and inflammatory pathways in the liver, inflammatory cells, muscle, fat, and intestinal tissues and has the potential to improve cholestasis, the key mechanism in play in PBC.
PBC is characterized by impaired bile flow (known as cholestasis) and the accumulation of toxic bile acids in the liver, leading to inflammation and destruction of the bile ducts within the liver and causing increased levels of alkaline phosphatase (ALP) and total bilirubin. The most common early symptoms of PBC are itching (pruritus) and fatigue,1 which can be very debilitating for some people. Other early symptoms include abdominal pain, nausea, poor appetite, weight loss and arthritis.1 Symptoms that may occur as PBC progresses include weakness, diarrhea, swelling in the legs, ankles or feet, dark urine, jaundice and raised patches on the skin.1 Progression of PBC is associated with an increased risk of liver cancer and liver-related mortality.
