#CHEST2016 – Bayer to Present Data from Phase 3 Trial on Non-CF Bronchiectasis Therapy

#CHEST2016 – Bayer to Present Data from Phase 3 Trial on Non-CF Bronchiectasis Therapy

Bayer will present data from current trials in non-cystic fibrosis (non-CF) bronchiectasis and pulmonary arterial hypertension at the American College of Chest Physicians (CHEST 2016) Oct. 22-26 in Los Angeles.

“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 news 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.”

Data presentations will include three oral sessions. Two will will be held at Late-Breaking Abstract sessions.

The study, “Efficacy and Tolerability of Ciprofloxacin Dry Powder for Inhalation (Ciprofloxacin DPI) in Bronchiectasis (Non-CF Etiology): Results from the Phase III RESPIRE 1 Study,” will be presented by Dr. Kevin Winthrop from Oregon Health & Science University at 9:22 a.m. Oct. 25.

Ciprofloxacin DPI is an experimental therapy under development to reduce exacerbations in non-CF bronchiectasis patients with bacterial respiratory infections. The therapy contains antibiotic ciprofloxacin in a powder solution that is inhaled from a handheld device developed by Novartis (the PulmoSphere technology).

The RESPIRE 1 trial (NCT01764841) evaluated whether treatment with ciprofloxacin DPI could be used as a long-term intermittent therapy in non-CF bronchiectasis patients.

The study evaluated whether first-time pulmonary exacerbation of bronchiectasis or its frequency could be prolonged by inhaling ciprofloxacin for 28 days every other 28 days, or for 14 days every other 14 days, over a period of 48 weeks.

In 2014, the U.S. Food and Drug Administration (FDA) granted Qualified Infectious Disease Product (QIDP) designation to Bayer’s ciprofloxacin DPI. QIDP status refers to antimicrobial drugs developed to treat serious and life-threatening infections.

Additionally at Chest 2016, Bayer will present new data on Adempas (riociguat) therapy for pulmonary arterial hypertension. The oral presentations are titled “Effects of Riociguat in Treatment-Naïve vs. Pretreated Patients with Pulmonary Arterial Hypertension: 2-year Efficacy Results from the PATENT-2 Study” and “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.”

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