PolyPid touted interim data today from the 1st group of patients to reach the 6-month follow-up period in the clinical trial of its BonyPid-1000 doxycycline-eluting synthetic bone substitute.
The Israel-based company’s clinical trial enrolled 64 patients with open tibia fractures. In this type of fracture, the bone is severely damaged and exposed, leaving it vulnerable to contamination by environmental bacteria.
The study’s objective is to determine the safety and performance of standard of care plus BonyPid-1000 on bone healing over 6- and 12-month periods, compared to standard of care alone. The primary endpoint is radiographic-assessed bone healing, based on independent blinded central radiographic evaluations of the target fracture’s x-rays, PolyPid reported.
According to interim data from the 1st group of patients, patients who were treated with BonyPid-1000 experienced less time between surgery and initiation of bone healing compared to the control group. Also, the patients who received BonyPid-1000 reached the study’s primary performance endpoint in 75 days compared to 112 days for their counterparts in the control arm.
At 16 weeks, more than 30% of patients treated with standard of care alone did not reach the primary performance endpoint, compared to 8% of patients treated with standard of care plus BonyPid-1000.
More than 60% of patients receiving BonyPid-1000 demonstrated pain-free weight bearing 4 months after surgery, while none of patients receiving just standard of care achieved pain-free weight bearing.
Consistent with previous clinical work, the company reported no product-related adverse events.
“We are extremely pleased with these interim data,” CEO Amir Weisberg said in prepared remarks. “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.”
The company said it plans to enroll the study’s last patient by the end of this year.