ICYMI: Study of Primary Biliary Cholangitis Treatment Shows Positive Results

CymaBay Therapeutics has recently released the results from ENHANCE, a study of seladelpar as a treatment for primary biliary cholangitis (PBC). These results were positive, proving that this medication has anti-inflammatory and anti-cholestatic effects.

About Primary Biliary Cholangitis (PBC)

PBC is a liver disease that is characterized by progressive damage of the bile ducts in the liver. This damage leads to cirrhosis that has the potential to cause liver failure. Initial symptoms include fatigue, itching, darkening of the skin, dry mouth, pain in the muscles and joints, and small bumps under the skin. As the disease progresses, symptoms evolve into jaundice, swelling of the feet and legs, diarrhea, internal bleeding, an underactive thyroid, a distended abdomen, and fragile bones. The cause of these symptoms is unknown, but medical professionals suspect that an environmental trigger causes an autoimmune response that attacks the liver.

Seladelpar as a Treatment for PBC

Seladelpar is a selective and potent peroxisome proliferator-activated receptor delta agonist, and it was evaluated in a randomized and placebo-controlled phase 3 trial. 265 participants received either a placebo, 5 mg of seladelpar, or 10 mg of seladelpar.

Researchers defined the primary endpoint as a 15% decrease from baseline of ALP levels and normal levels of total bilirubin. 167 participants met these endpoints; 78.2% of the 10 mg group and 57.1% of the 5 mg group. Other measures are:

  • Dose-dependent reduction in pruritus (symptom of PBC)
  • Anti-inflammatory response
    • Decrease in ALT
    • Decrease in GGT
  • Favorable safety and tolerability profile

These results reinforce the conclusion that seladelpar is an effective treatment for PBC. Hopefully it will be able to better the lives of those with this condition.

Find the source article here.


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