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PALO ALTO, Calif. -- IntraBiotics Pharmaceuticals, Inc. announced that it has reached Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA) on the design of the pivotal trials to be conducted in support of registration of iseganan for use in patients receiving mechanical ventilation to reduce the risk of pneumonia (VAP). The SPA letter from the FDA documents the agreed upon terms and conditions under which IntraBiotics will conduct and analyze the data from two identical pivotal, randomized, double-blind, placebo-controlled, multinational clinical trials. The company expects to begin enrollment in the first trial by the end of September and to complete that trial and announce its results by the end of 2004.
Earlier this month, the company announced that the FDA granted iseganan fast-track designation for this development program.
"We have appreciated our collaboration with the FDA throughout the SPA process on this development program, which has been designed to address an unmet medical need for mechanically-ventilated patients who are at high risk for developing VAP. Having the same endpoint for both trials enables us to have a good sense of whether iseganan will be successful upon completion of the first trial. Agreement with the FDA on the design of these clinical trials is important to assure expeditious registration if the trials are successful," said Dr. Henry Fuchs, president and CEO of IntraBiotics.
Following successful completion of the studies, the company expects to file a New Drug Application (NDA).
The pivotal trials are designed to assess the safety and efficacy of iseganan and to demonstrate iseganan's ability to reduce the incidence of pneumonia in patients who are receiving mechanical ventilation. In each trial, approximately 900 patients will be enrolled and will be randomized to receive either iseganan or placebo six times per day as part of routine oral hygiene for up to 14 days while patients are mechanically ventilated. To complete these clinical trials, additional capital will need to be raised.
Iseganan hydrochloride (HCl) oral solution is a broad-spectrum antimicrobial peptide that functions by a novel mechanism of action, which may substantially reduce the likelihood of microbial resistance. Iseganan is the first in a new class of investigational peptide drugs known as protegrins, which are naturally-occurring substances found in mammals where they form part of the first line of defense against invading bacteria and fungi.
Pneumonia is the most common infection among ventilated patients in the intensive care unit. The longer a patient is ventilated, the higher the risk of developing VAP. Approximately 15-30 percent of patients receiving mechanical ventilation for more than 48 hours get VAP. The company estimates that more than 1 million patients annually are mechanically ventilated for more than 48 hours in North America, Western Europe and Japan combined, making VAP a significant unmet medical need. Despite the use of potent, broad-spectrum, antibiotics, patients who develop VAP generally remain dependent on artificial ventilation and remain in the intensive care unit for longer periods of time than patients who do not develop VAP. As a consequence, studies have demonstrated that patients who develop VAP can incur more than $40,000 in additional hospital charges.
Source: IntraBiotics Pharmaceuticals, Inc.