#CHEST2016 – Bayer to Present New Data on PAH and Bronchiectasis Therapies

#CHEST2016 – Bayer to Present New Data on PAH and Bronchiectasis Therapies

Bayer announced it will be giving three oral presentations on lead investigative therapies Adempas (riociguat) for the treatment of pulmonary arterial hypertension (PAH), and ciprofloxacin DPI (dry powder for inhalation) to treat non-cystic fibrosis bronchiectasis (NCFB).

Data on the two therapies will be presented at the upcoming annual meeting of the American College of Chest Physicians (CHEST 2016) Oct. 22-26 in Los Angeles.

Bayer will give two presentations on Adempas for PAH:

  • Effects of Riociguat in Treatment-Naïve vs. Pretreated Patients with Pulmonary Arterial Hypertension: 2-year Efficacy Results from the PATENT-2 Study,” at 5:15 p.m. Oct. 24.
  • The Relationship between NO Pathway Biomarkers and Response to Riociguat in the RESPITE Study of Patients with PAH Not Reaching Treatment Goals with Phosphodiesterase 5 Inhibitors,” 9:03 a.m. Oct. 25.

One presentation on ciprofloxacin DPI for NCFB is planned:

  • Efficacy and Tolerability of Ciprofloxacin Dry Powder for Inhalation (Ciprofloxacin DPI) in Bronchiectasis (Non-CF Etiology): Results from the Phase III RESPIRE 1 Study,” 9:22 a.m. Oct. 25.

PAH is defined by elevated pressure in the arteries going from the right side of the heart to the lungs. Adempas is a stimulator of soluble guanylate cyclase (sGC); it is the only treatment approved in the U.S. for PAH and chronic thromboembolic pulmonary hypertension (CTEPH).

Adempas is indicated for the treatment of adult PAH patients to improve exercise capacity, WHO PAH functional class, and to delay disease progression. The drug demonstrated its effectiveness as a single therapy and in combination with endothelin receptor antagonists or prostanoids.

The PATENT-2 study (NCT00863681) is a Phase 3 long-term extension trial to assess the safety and tolerability of Adempas in PAH patients. The study will run for four years and 10 months, and Bayer is present data from an interim analysis after two years of treatment.

In patients with NCFB, sputum accumulates in the small airways, making them a perfect place for bacterial growth and frequently leading to chronic airway infections like those caused by Haemophilus influenzae or Pseudomonas aeruginosa.

Ciprofloxacin DPI is an investigational drug developed as a long-term intermittent therapy to reduce exacerbations in NCFB patients with bacterial respiratory pathogens. It comprises ciprofloxacin, a fluoroquinolone antibiotic, that has been formulated into a dry powder for inhalation using PulmoSphere technology.

Ciprofloxacin DPI was evaluated for its ability to be used as a long-term therapy in NCFB in the Phase 3 RESPIRE 1 clinical trial (NCT01764841). Results of the study will now be presented at CHEST 2016.

“Our data reflects Bayer’s commitment to advancing the scientific research in diseases of high unmet need, particularly pulmonary arterial hypertension and non-cystic fibrosis bronchiectasis,” said Aleksandra Vlajnic, vice president of medical affairs at Bayer, in a press release.

“We will continue working with physician and patient communities to increase understanding of these diseases and help accelerate time from diagnosis to treatment for these commonly under-detected, and therefore under-treated, pulmonary conditions,” she said.

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