The BonyPid®-1000-103 trial is a randomized, single-blind standard of care controlled study in a total of 64 patients with open tibia fractures (Gustilo IIIA and IIIB), a severe clinical condition resulting from a high energy traumatic event where the bone is severely damaged and exposed and, therefore, assumed to be contaminated by environmental bacteria. This multi-center study is being conducted at six clinical sites in Israel and three in Asia. The objective of the study is to determine performance and safety of standard of care (SOC) plus BonyPid®-1000 on bone healing in traumatic open fracture patients over a period of six and 12 months, compared with SOC alone. The primary performance endpoint is radiographic-assessed bone healing during the 24-week follow-up period, based on independent blinded central radiographic evaluations of the target fracture’s x-rays.
Based on the interim results from the first group of patients to reach the 16-week follow-up period, 12 patients treated with standard of care SOC plus BonyPid®-1000 versus 13 patients treated with SOC alone, time from surgery to the initiation of bone healing as assessed by the treated physicians (callus in one out of four cortices) was reduced by approximately 33% in the BonyPid®-1000 plus SOC treated group (95% confidence interval for 75% of the patients). Moreover, solid radiographic markers for bone healing (callus in three of four cortices), the study’s primary performance endpoint, was reduced by 32%, 75 days in patients treated with BonyPid®-1000 plus SOC, versus 110 days in patients receiving SOC alone (95% confidence interval for 50% of the patients). In addition, at 16 weeks time, more than 30% of the patients treated with SOC did not achieve the primary performance endpoint, versus 8% of the patients treated with SOC plus BonyPid®-1000. These results are consistent with the evaluation from the independent radiographic, where time to the initiation of solid bone healing (callus in three out of four cortices) was reduced by 28%, 82 days in patients treated with BonyPid®-1000 plus SOC, versus 114 days in patients receiving SOC alone (95% confidence interval for 50% of the patients). In addition, pain-free weight bearing was demonstrated in 63% of the patients receiving BonyPid®-1000 plus SOC four months post-surgery, versus none of the patients (0%) receiving SOC alone.
“We are extremely pleased with these interim data,” said Amir Weisberg, PolyPid’s Chief Executive Officer. “These compelling results further expand the growing body of clinical evidence highlighting the effectiveness of our BonyPid®-1000 in promoting bone healing and its potential in reducing the economic burden caused by prolonged recovery times. A significant unmet medical need exists for patients suffering from severe open fractures in order to reduce surgical interventions and bone healing time. Based on the data generated to date, we believe BonyPid®-1000 has the potential to address this treatment void, and we look forward to continuing our BonyPid®-1000-103 study.”
As in previous clinical studies, there were no product-related adverse events reported in the patients receiving BonyPid®-1000 plus SOC. PolyPid anticipates enrolling the last patient into the study by year-end 2017.
BonyPid®-1000 is a bone graft substitute eluting doxycycline hyclate, a broad-spectrum antibiotic. The antibiotic is released locally over a prolonged period of four weeks by the PLEX™ technology. BonyPid®-1000 has successfully completed multiple pilot clinical trials in the severe open fracture indication, demonstrating excellent safety and efficacy results, including 0% infections in the target fracture, and 0% amputations after six to 12 months of 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, PLEX™ (Polymer-Lipid Encapsulation matriX), in the field of extended release, local drug delivery. PLEX™ technology optimizes drug therapeutic performance and clinical outcomes, improves pharmacoeconomic potential and offers lifecycle extension for novel drugs. This is achieved via protected drug reservoirs enabling 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. PLEX™-based products have demonstrated an excellent safety profile during extended clinical studies, with over 65 patients exposed to the technology to date. PolyPid’s technology and products are based on the inventions of Dr. Noam Emanuel, the founder and the chief technology officer of the company.
PolyPid’s lead product, D-PLEX™, is a secure antibiotic drug reservoir that provides a safe and effective local anti-bacterial preventive and eradication treatment at the target site and is designed to be administered during surgical procedures. After surgery, the drug reservoir constantly releases the entrapped antibiotic over several weeks, thus allowing prolonged infection management with increased potential to eradicate antibiotic resistant bacteria.
For additional company information, visit http://www.polypid.com.
Dikla Czaczkes Akselbrad
Chief Financial Officer
Bob Yedid, Managing Director