According to a story from BioSpace, the biopharmaceutical company POXEL SA has recently announced that it has commenced with a phase 2 dose ranging clinical trial which will test the company’s experimental drug PXL065 as a possible treatment for nonalcoholic steatohepatitis (NASH), a disease that affects the liver. The trial is expected to include 120 patients who have been diagnosed via biopsy and have not yet begun to experience cirrhosis (scarring). POXEL specializes in the development of novel therapies for metabolic disorders.
About Nonalcoholic Steatohepatitis
Nonalcoholic steatohepatitis (NASH) is a type of liver disease in which fat is deposited in the liver independent of excessive alcohol consumption. This disease can progress rapidly. Risk factors include metabolic syndrome and insulin resistance. There also appears to be some genetic component to the disease as well. This condition also increases the risk of other health problems and liver cancer. Males also seem to be at greater risk, getting the disease as almost twice the rate that females do. Symptoms of nonalcoholic steatohepatitis include jaundice, malaise, fatigue, and abdominal pain or discomfort. Without treatment, the liver can become scarred and the patient may need a liver transplant. However, the condition can also be managed with proper diet, the use of certain medications, and exercise. To learn more about nonalcoholic steatohepatitis, click here.
PLX065 is classified as a deuterium-stabilized R-pioglitazone. Pioglitazone has been researched as a treatment for the illness but is not FDA approved. It has shown compelling activity in treating the disease, but the original form carries problematic side effects, such as fluid retention, bone fractures, and weight gain. The use of deuterium as a stabilizer aims to reduce these adverse effects.
About The Trial
The phase 2 trial will analyze three different doses of the medication in order to assess the optimal dose for future trials. The doses to be tested are 7.5 mg, 15 mg, and 22.5 mg, which will be compared to placebo. The study is expected to run for 36 weeks. The primary endpoint will be change in the percentage of the liver’s fat content.
As pioglitazone already has an established body of data that indicates its capabilities in treating nonalcoholic steatohepatitis, the PLX065 formulation has the potential to offer a more practical and effective form of the drug that won’t plague patients with adverse effects. Hopefully, this drug will perform will in this trial.