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February 25, 2020updated 19 Sep 2022 12:17pm

United Therapeutics’ Tyvaso meets goals in PH-ILD patients

United Therapeutics has reported that the Tyvaso (treprostinil) inhalation solution met all primary and secondary endpoints in the Phase III INCREASE trial involving patients with pulmonary hypertension caused by interstitial lung disease (PH-ILD).

United Therapeutics has reported that the Tyvaso (treprostinil) inhalation solution met all primary and secondary endpoints in the Phase III INCREASE trial involving patients with pulmonary hypertension caused by interstitial lung disease (PH-ILD).

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Direct-to-Patient Trials: How IRT Plays an Important Role in Bellerophon's Direct-to-Patient Trials

As the industry strengthens its focus on patient centricity, Direct-to-Patient clinical trials have emerged as a popular trial design that have the potential to increase patient recruitment and retention. IRT plays a crucial role in the success of a Direct-to-Patient trial. Because drug supplies are being managed and shipped from distribution facilities directly to patients’ homes, a sponsor must have a high-quality system in place to accurately track the chain of custody, ensure patient-blinding and handle other logistical challenges. What You Will Learn Benefits and challenges associated with the Direct-to-Patient model Bellerophon's top considerations when implementing this trial design How IRT can equip study teams to successfully track chain of custody, ensure patient blinding, and handle logistical challenges
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Tyvaso is a prostacyclin vasodilator intended to improve exercise ability in pulmonary arterial hypertension patients.

The multi-centre, randomised, double-blinded, placebo-controlled, parallel-group, 16-week INCREASE study compared the drug to placebo in 326 patients. Participants in the treatment group were given up to 12 breaths per session, four times per day.

The primary endpoint was the change in six-minute walk distance (6MWD) from baseline to week 16.

According to preliminary data, Tyvaso met the primary goal with a 21m increase in 6MWD compared to placebo following 16 weeks of treatment.

The drug also led to significant improvements in the trial’s secondary endpoints, including a decrease in the NT-proBNP cardiac biomarker, time to first clinical worsening event, peak 6MWD change at week 12 and trough 6MWD change at week 15.

Results further revealed that Tyvaso was well-tolerated with a safety profile that is consistent with prior PAH data and known prostacyclin-related adverse events.

INCREASE Study Steering Committee chair Aaron Waxman said: “Patients with both interstitial lung disease and pulmonary hypertension have worse clinical trajectories and earlier death than patients with interstitial lung disease alone.

“There are currently no approved therapies for these patients and so there is a tremendous unmet need. This is the largest clinical trial in this population and the first to demonstrate a clear benefit.”

In the coming months, the company will submit the INCREASE trial data to the US Food and Drug Administration (FDA) to seek approval in this indication.

Earlier this month, United Therapeutics reported that Unituxin (dinutuximab) in combination with irinotecan failed to meet the primary endpoint in Phase II/III DISTINCT trial in small cell lung cancer (SCLC).

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Direct-to-Patient Trials: How IRT Plays an Important Role in Bellerophon's Direct-to-Patient Trials

As the industry strengthens its focus on patient centricity, Direct-to-Patient clinical trials have emerged as a popular trial design that have the potential to increase patient recruitment and retention. IRT plays a crucial role in the success of a Direct-to-Patient trial. Because drug supplies are being managed and shipped from distribution facilities directly to patients’ homes, a sponsor must have a high-quality system in place to accurately track the chain of custody, ensure patient-blinding and handle other logistical challenges. What You Will Learn Benefits and challenges associated with the Direct-to-Patient model Bellerophon's top considerations when implementing this trial design How IRT can equip study teams to successfully track chain of custody, ensure patient blinding, and handle logistical challenges
by Suvoda
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