Date: 2016-06-06
Type of information: Completion of the trial
phase: 1
Announcement: completion of the trial
Company: Polyphor (Switzerland)
Product: POL6014
Action
mechanism: antibiotic/elastase inhibitor. POL6014 is a highly selective, potent and reversible inhibitor of human neutrophil elastase (hNE), which is implicated in a number of severe respiratory diseases that frequently lead to life-threatening progressive lung deterioration as, for instance, in the orphan lung diseases Alpha-1 Antitrypsin (AAT) Deficiency and Cystic Fibrosis (CF). The hNE enzyme is present in the healthy lung where it is inhibited by natural protease inhibitors, in particular AAT. In AAT deficient patients this natural inhibitor is produced in insufficient quantities, which results in high levels of uninhibited elastase. This often leads to severe or even fatal lung deterioration. Progressive lung disease determines the morbidity and mortality of CF patients. Chronic bacterial infections are considered an important factor in stimulating inflammatory processes in CF. The resulting chronic inflammation triggers the body to produce, among other enzymes, an excess of elastase, which, if not controlled, leads to lung deterioration. Inhibition of elastase by inhaled POL6014 could therefore be a promising therapeutic approach.
Disease: cystic fibrosis, alpha-1 antitrypsin (AAT) deficiency
Therapeutic area: Infectious diseases - Rare diseases - Respiratory diseases
Country:
Trial details:
Latest
news: * On June 6, 2016, Polyphor announced the successful completion of its clinical Phase I study with inhaled POL6014 in healthy volunteers. This randomized, double-blind, placebo-controlled dose-escalation Phase I study was designed to investigate the safety, tolerability and pharmacokinetics of inhaled single doses of POL6014 in healthy volunteers. The compound was very well tolerated in all treatment groups. No serious adverse events were reported, and the measured pharmacokinetic parameters increased proportionally with the dose administered using a customized Pari eFlow® aerosol inhaler. Polyphor has now initiated two clinical Phase Ib trials investigating the safety, pharmacokinetics, and pharmacodynamics of POL6014 in individuals with cystic fibrosis and non-cystic fibrosis bronchiectasis. * On September 1, 2015, Polyphor, a privately held pharmaceutical company specialized in the discovery and development of macrocycle drugs, announced the initiation of recruitment in a first in man clinical Phase I study with inhaled POL6014, Polyphor’s proprietary macrocycle drug candidate. The randomized, double-blind, placebo-controlled dose-escalation Phase I study is designed to investigate safety, tolerability and pharmacokinetics of inhaled single doses of POL6014 in healthy volunteers. The study aims to establish a safe maximum tolerated dose for future clinical studies.
