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Pharmaceutical industry

CoTherix Initiates Phase II Trial for Ventavis to Treat Pulmonary Hypertension in Idiopathic Pulmonary Fibrosis

Strategic Insights

— 1 min read

CoTherix, Inc., has initiated a phase II trial for its marketed product, Ventavis (iloprost) Inhalation Solution, aiming to expand its indication to include pulmonary hypertension (PH) associated with idiopathic pulmonary fibrosis (IPF). The double-blind, placebo-controlled trial, known as the ACTIVE trial, will enroll approximately 50 patients at 15 sites in the United States. The primary objective of the study is to determine the safety of Ventavis in patients with PH associated with mild or moderate IPF.

The study will also assess other clinically relevant measures, including the 6-minute walk test, NYHA class change, and hemodynamic parameters. "Ventavis is an ideal candidate to investigate for IPF patients with pulmonary hypertension," said James Pennington, MD, executive vice president and chief medical officer of CoTherix, Inc. With Ventavis already on the market for PAH, this trial underscores the company's strategy to continue its leadership position in inhaled therapies for pulmonary diseases.

Key Takeaways:

  • CoTherix initiated a phase II trial for Ventavis (iloprost) Inhalation Solution to treat pulmonary hypertension in idiopathic pulmonary fibrosis (IPF).
  • The trial, known as the ACTIVE trial, will enroll approximately 50 patients at 15 sites in the United States.
  • The primary objective of the study is to determine the safety of Ventavis in patients with PH associated with mild or moderate IPF.
  • The study will also assess other clinically relevant measures, including the 6-minute walk test, NYHA class change, and hemodynamic parameters.
  • Ventavis is an inhaled treatment option that targets nonfibrotic portions of the diseased lung, increasing vasodilation and reducing potential mismatched ventilation and blood flow.
  • Treatment options for patients with IPF are extremely limited.
  • The study highlights the significant need for new therapies to treat the pulmonary hypertension complications of this progressive disease.
  • Ventavis has already shown significant improvements in several key clinical parameters in the recently released STEP clinical study.
  • CoTherix licensed exclusive rights to develop and commercialize Ventavis in the United States from Schering, AG, in October 2003.

Statistics:

  • 50 patients will be enrolled in the ACTIVE trial
  • 15 sites in the United States will participate in the trial
  • 4 months have passed since the NDA was accepted by the FDA and granted priority review with orphan drug designation (August 2004 - December 2004)
  • Prior to the introduction of Ventavis, prostacyclin therapies for PAH required continuous delivery through subcutaneous or intravenous routes

Sources:

  • CoTherix, Inc. Press Release
  • World Health Organization
  • U.S. Food and Drug Administration (FDA)
  • Health & Medicine Week
  • NewsRx.com

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