Zürich, Switzerland, March 01, 2016 --(PR.com
)-- Ixodes AG, a pharmaceutical company focused on developing and commercializing therapeutic products for the prevention of Lyme Disease, today announced that the company has reached agreement with the US Food and Drug Administration (FDA) on the phase III protocol according to the Special Protocol Assessment (SPA) for its lead product candidate, Ixogel®, for the prevention of Lyme Disease after a tick bite. FDA had already designated Ixogel® as a Qualified Infectious Disease Product (QIDP).
The QIDP designation has made Ixogel® eligible to benefit from certain incentives as provided under the Generating Antibiotic Incentives Now (GAIN) program. These incentives include FDA priority review and eligibility for fast-track status and – provided that FDA approval is obtained - , Ixogel® would also be eligible for an additional five-year extension of Hatch-Waxman patent exclusivity.
Ixogel® is a novel topical formulation of Azithromycin applied at the site of the tick bite within 3 days after the bite. Ixogel® provides a preventative solution by eradicating Borrelia in the skin before they disseminate and which can lead to Lyme Disease. Ixogel® demonstrated an excellent safety profile and a trend to prevent symptoms of Lyme Disease in a European human clinical trial. A phase III clinical Special Protocol Assessment (SPA) has now been agreed upon with the FDA. For Europe the clinical design has been approved by the German Health Authority BfArM.
"Ixodes AG is delighted that the FDA has agreed on our phase III protocol according to Special Protocol Assessment (SPA) and given Ixogel® a QIDP designation, further affirming the importance of addressing the serious medical need related to Lyme Disease due to tick bites," says Gustave Huber, Ixodes Chief Executive Officer. "The QIDP designation and the SPA agreement with the FDA on the Phase III protocol will strongly support our goal to bring Ixogel® to the U.S. and European markets as fast as possible."
In order to achieve QIDP designation, a drug product must be intended to treat serious or life-threatening infections, particularly infections caused by "qualified pathogens" as determined by the FDA. These pathogens include Borrelia burgdorferi, the pathogen causal for Lyme Disease.
Ixogel's accelerated approval designation provides Ixodes AG with the opportunity to meet with the FDA on a more frequent basis during the review process and provides eligibility for priority review of the marketing application.
About Ixodes AG / Ixogel®
Ixodes AG is a privately held company in Zurich, Switzerland. Its main focus is on the development of Ixogel®, a novel topical application of Azithromycin to prevent Lyme Disease. After a tick bite, the causal pathogen leading to Lyme Disease - Borrelia burgdorferi - remains at the site of the bite in the skin for some time. Ixogel® uses this time window to eradicate the pathogen locally, thereby preventing its dissemination and thus the development of Lyme Disease. Ixodes holds an approved clinical protocol with the FDA as well as the approval for the clinical design with the German BfArM.
Media contact: Luzi von Bidder, Ixodes@bluewin.ch , Phone +41 44 919 05 78
About Lyme Disease
Lyme disease in North America is caused by the bacterium Borrelia burgdorferi and is transmitted to humans via the skin through the bite of infected blacklegged Ixodes scapularis ticks. In Europe, Lyme Disease can also be the result of Borrelia afzelii and Borrelia garinii infections which are typically transmitted by Ixodes ricinus. Symptoms include fever, headache, fatigue, and a characteristic skin rash called erythema migrans. If left untreated, infection can affect joints, the heart, and the nervous system.
Lyme Disease is a Disease associated with morbidity that has substantial impact on day-to-day functioning. It concentrates in the northeast and upper Midwest of the US and is the most commonly reported vector-borne Disease in the United States. The Centre of Disease Control (CDC) recently reported > 330,000 new cases of Lyme Disease in the US per year. Ixodes AG estimates that the number of new cases in Central and Northern Europe amounts to > 300,000 annually.