New Data on Phase 3 Trial of Quinsair for Cystic Fibrosis Presented by Raptor at European CF Conference

New Data on Phase 3 Trial of Quinsair for Cystic Fibrosis Presented by Raptor at European CF Conference

At the 39th European Cystic Fibrosis Conference, recently held in Basel, Switzerland, Raptor Pharmaceutical presented new data on its Phase 3 MPEX-209 clinical trial comparing Quinsair to inhaled tobramycin solution in patients with chronic Pseudomonas aeruginosa infections linked to cystic fibrosis (CF).

Cystic fibrosis is a rare, life-threatening genetic disease that causes persistent lung infections due to the buildup of thick, sticky mucus in the lungs, and which progressively limits the patient’s ability to breath. The lung infections are mostly caused by bacteria, with 75 percent of cystic fibrosis patients suffering from chronic P. aeruginosa infections.

Quinsair is a proprietary inhaled formulation of levofloxacin, approved in the E.U. and in Canada for the management of chronic pulmonary infections due to P. aeruginosa in adult patients with cystic fibrosis.

“Patients with cystic fibrosis have few approved inhaled antimicrobial options for the treatment of chronic Pseudomonas infection and in many cases, continue to have pulmonary exacerbations despite available therapies,” said Krishna R. Polu, M.D., chief medical officer at Raptor, in a press release. “We believe it is critically important to provide physicians with additional data that suggest that Quinsiar may reduce the number of pulmonary exacerbations in patients with a history of frequent pulmonary exacerbations. Further analyses suggest that Quinsair administration did not increase the risk for colonization with new pathogens or lead to increased antimicrobial susceptibilities.”

Two posters about Quinsair were presented at the Conference:

  • History of Pulmonary Exacerbations (PEx) as a Predictor of Response to Nebulized Levofloxacin Compared with Nebulized Tobramycin, P.A. Flume — Poster No. 38.

MPEX-209 was a randomized, controlled, open-label clinical trial comparing treatment with Quinsair with tobramycin inhalation solution over three cycles of 28 days alternating with treatment pauses of 28 days.

Patients taking part in the trial were sorted by prior-year pulmonary exacerbation history as zero, one to two, or three or more. Prior-year pulmonary exacerbation was defined as events that led to antibiotic treatment among patients meeting at least four of 12 respiratory signs and symptoms.

The results demonstrated that patients with three or more prior year pulmonary exacerbations who were treated with Quinsair had a lower incidence of these events than patients who were treated with tobramycin. The most common treatment-related adverse events observed during the study included fatigue/asthenia, cough/productive cough, and dysgeusia.

  • Microbiologic Changes Observed over 6 months in a Randomized, Open-Label Comparison of Inhaled Levofloxacin and Inhaled Tobramycin in Persons with CF and Chronic aeruginosa(Pa) Airway Infection, D.R. VanDevanter — Poster No. 37.

In the Phase 3 MPEX-209 trial comparing inhaled levofloxacin and inhaled tobramycin, there were no clinical changes or differences between the two treatment groups considering the amount of P. aeruginosa isolates vulnerable to levofloxacin, tobramycin, aztreonam, or meropenem, or the amount of isolates not vulnerable to three of these four classes.

During the course of the study there were no significant changes on the prevalence of cystic fibrosis bacterial opportunists within or between treatment groups.

The most common treatment-related adverse events observed during the study were also fatigue/asthenia, cough/productive cough, and dysgeusia.

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