Development of “Add-on” Therapy for Pulmonary Arterial Hypertension Ends After Poor Trial Showing

According to a story from Pulmonary Hypertension News, the drug developer United Therapeutics recently issued a statement in which the company announced that it was ceasing the development of esuberaprost as a supplemental treatment for pulmonary arterial hypertension, a rare lung condition. The drug was intended to be used alongside Tyvaso, one of the company’s currently available products that is used to treat the illness. The decision was based on disappointing results from a Phase 3 clinical trial.

About Pulmonary Arterial Hypertension (PAH)

Pulmonary arterial hypertension is a condition in which the blood pressure in the arteries of the lungs is abnormally high. The cause of pulmonary arterial hypertension is often unknown in many cases. However, there are a variety of potential causes, such as certain heritable genetic mutations, exposure to certain toxins, and drug use (ex. methamphetamine). It can also appear as a symptom or complication in a number of other diseases, such as heart disease, connective tissue disease, and infection with HIV. The arteries in the lungs are often inflamed. Symptoms of this condition include rapid heartbeat, poor exercise tolerance, shortness of breath, fainting, leg swelling, fatigue, and chest pain. Treatment may include a number of medications and surgical operations, including lung transplant. A transplant can cure the condition, but it can cause many complications. Survival rate is often only about two or three years without treatment, but the latest drugs can prolong life by several years or more. Click here to learn more about pulmonary arterial hypertension.

Study Results

The primary endpoint of the study, which included 240 pulmonary arterial hypertension patients, was delayed time until signs of clinical worsening events became apparent. Unfortunately, esuberaprost was unable to have a meaningful effect on this endpoint. All of the patients in the trial were also treated with Tyvaso.

Esuberaprost is intended to replicate the activity of the molecule prostacyclin, which is produced by the body and has a blood vessel dilating effect. Concentrations of this molecule are strangely low in pulmonary arterial hypertension patients and is believed to contribute to the development of the illness. Despite this scientific basis, the experimental drug was unable to produce meaningful clinical effect.

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