PolyPid Announces First Patient Enrolled in Confirmatory Clinical Trial, Evaluating Performance and Safety of D-PLEX1000, an Antibiotic Eluting Bone Void Filler
Petah Tikva, Israel, December 2, 2015. PolyPid Ltd., an emerging clinical stage specialty pharmaceutical company, focused primarily on the development of post-surgical anti-infection pipeline, announced today the enrollment of the first patient in the confirmatory clinical trial of BonyPid-1000™, a doxycycline loaded synthetic bone substitute.
The BonyPid-1000-103 trial is a randomized, single-blind standard of care controlled study and is expected to be conducted on a total of 64 patients with severe open tibia fractures (Gustilo IIIA and IIIB), at five sites in Israel and three in Asia. The primary endpoint of the study is to determine performance and safety of BonyPid-1000™ on bone healing in traumatic open fracture patients, over a period of 6 and 12 months, compared with standard of care. The first patient has been enrolled at the Tel Aviv Sourasky Medical Center, Israel.
Dr. Noam Emanuel, PolyPid’s CTO, stated “We are very pleased to commence our final, CE mark certification clinical trial for BonyPid-1000™, our PLEX based product addressing such a significant unmet medical need. This study expands our existing successful clinical data”. Dr. Emanuel added “Severe open fracture patients are highly prone to infection at the fracture site causing an increased number of surgical interventions, longer healing time and higher amputation rates.”
BonyPid-1000™ is a bone graft substitute containing a broad-spectrum antibiotic, doxycycline hyclate, to reduce microbial colonization on the bone void filler. The antibiotic is released locally over a prolonged period of 4 weeks. BonyPid-1000™ has completed sucssesfully pilot clinical trials in open fracture indication, demonstrating excellent safety and efficacy results, including 0% infections in the target fracture and 0% amputations after 6-12 months follow up (vs. an average of 25% and 7% respectively in a historical control group of patients).
PolyPid is a clinical stage, emerging specialty pharmaceutical company, developing, manufacturing and commercializing products based on a proprietary platform named PLEX™ (Polymer-Lipid Encapsulation matriX), in the field of extended release, local drug delivery. PLEX™-based protected drug reservoirs enable prolonged delivery of drugs, including biologics, over periods ranging from days to several months. The application of PLEX™ technology enables optimized drug treatment regimens by predetermining release rates and durations, a rare combination of attributes.
PolyPid’s lead product, D-PLEX™, is a secured antibiotic drug reservoir. It provides safe and effective local anti-bacterial preventive measure and eradication at the target site by administration during surgical procedures. After surgery the reservoir constantly releases the entrapped antibiotic over several weeks. It thus allows for prolonged infection prevention or treatment and also has the potential to eradicate resistant bacteria. For additional company information, visit www.polypid.com
Dikla Czaczkes Akselbrad
Chief Strategy Officer
Kanaan Public Relations