United Therapeutics Corporation has recently presented data from the Phase 3 INCREASE trial, which evaluated Tyvaso as a treatment for pulmonary hypertension associated with interstitial lung disease. Results were presented at CHEST 2020, which was held from October 18-21 for the American College of Chest Physicians.

About Interstitial Lung Disease

Interstitial lung disease, also known as pulmonary fibrosis, is characterized by scarring of the tissue in the lungs. This damage leads to respiratory issues and other complications. Symptoms include shortness of breath, fatigue, a dry cough, unexplained weight loss, clubbing of the fingers and toes, and aches in the muscles and joints. It is important to seek treatment for this condition, as it can lead to complications like respiratory failure, lung cancer, lung infections, high blood pressure in the lungs, collapsed lungs, cardiac failure on the right side of the heart, and blood clots in the lungs.

These symptoms can be the result of a number of different causes, and at times there is no known cause at all. Possible causes of this condition include exposure to chemicals, taking certain medications, radiation treatment, and a different medical condition like polymyositis. Unfortunately, there is no cure or treatment to reverse damage. Doctors will prescribe medications to slow progression, use oxygen therapy and pulmonary rehabilitation to improve lung function, and provide symptomatic treatment. If a case is very severe, a lung transplant may be necessary.

The Data Presented

Pulmonary hypertension is a common result of interstitial lung disease, and it can make it significantly more difficult to breathe. Tyvaso was created to combat this. It was recently evaluated in the Phase 3 INCREASE trial, and results were presented to experts in the field at CHEST 2020.

The trial was multicenter, placebo-controlled, double-blind, randomized, and ran for 16 weeks. 326 participants were enrolled, all of whom had pulmonary hypertension as the result of interstitial lung disease. They either inhaled Tyvaso four times a day or were given a placebo.

Data revealed that all the primary and secondary endpoints were met; lung function was improved. Results include:

• Patients receiving Tyvaso experienced fewer exacerbations as a result of disease, at 26.4% vs. the 38.7% in the placebo group
• Forced vital capacity (FVC) improved by 44.40 mL when compared to placebo
• Tyvaso was well-tolerated, and the safety profile was maintained

As all of the results were positive, United Therapeutics submitted a New Drug Application to the FDA, which is currently under review. They also believe that Tyvaso could be a viable treatment for other forms of interstitial lung disease and plan to launch a phase 3 trial focusing on idiopathic pulmonary fibrosis. Hopefully further efforts are successful, as Tyvaso could provide a needed treatment option for patients.

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