LEXINGTON, Mass & SYDNEY–(BUSINESS WIRE)–GI Dynamics, Inc. (ASX: GID) (GI Dynamics or the Company), a medical device company developing innovative treatments for type 2 diabetes and obesity, announced today that the U.S. Food and Drug Administration (FDA) has placed a hold on enrollment in the Company’s ongoing pivotal clinical trial of EndoBarrier® Therapy (the ENDO Trial) in the U.S. Monitoring and data collection involving patients currently enrolled in the ENDO Trial will continue.
The decision to hold further enrollment results from 4 cases of a bacterial infection of the liver, known as hepatic abscess, among the 325 subjects currently enrolled in the ENDO Trial. Hepatic abscess is a known event related to the use of EndoBarrier but has recently presented at a higher than anticipated rate in the ENDO Trial. The FDA has therefore requested additional information to further assess the risk:benefit profile of the EndoBarrier in the ENDO Trial.
Outside of the U.S., the incidence rate of hepatic abscess is approximately 1% based on experience with more than 2,900 units shipped commercially since 2009. GI Dynamics believes that EndoBarrier’s overall risk:benefit profile, as established outside of the U.S., remains favorable. EndoBarrier therefore continues to be available for use by physicians and patients in the multiple countries where it is approved.
Patient safety is GI Dynamics’ first priority. The Company has already implemented several risk mitigation strategies in the ENDO Trial and is expeditiously working to submit the requested information to the FDA for their review in an effort to resume enrollment.
GI Dynamics will hold a conference call at 6:00 p.m. EST on 5 March 2015 (10:00 a.m. AEDT on 6 March 2015) to update investors regarding the ENDO Trial.
The webcast will be archived for 30 days following the call on the GI Dynamics website at investor.gidynamics.com.