FDA: QDIP Status for Post-Surgical Sternal Infection Antibiotic Reservoir
D-PLEX was found to be safe with no drug-related adverse events reported. Full study results are expected by year-end 2017.
The Food & Drug Administration (FDA) has granted Qualified Infectious Disease Product (QIDP) to D-PLEX (Doxycycline/Polymer-Lipid Encapsulation Matrix; PolyPid), a secured antibiotic drug reservoir for the local prevention and treatment of surgical infections.
D-PLEX is currently under investigation in a Phase 1/2 clinical trial in patients post-cardiac surgery. Initial findings from the ongoing study showed that treatment with D-PLEX is associated with no sternal infection during the 3 month follow-up. Additionally, D-PLEX was found to be safe with no drug-related adverse events reported. Full results of the study are expected by year-end 2017. PolyPid intends to initiate a Phase 3 study for D-PLEX in post-cardiac surgery sternal infection upon successful completion of the Phase 1/2 trial.
The Company is developing D-PLEX utilizing its proprietary PLEX (Polymer-Lipid Encapsulation matriX) technology platform to deliver an extended and constant release of antibiotic at the target site. The investigational drug product is designed for administration during surgical procedures. After surgery, the drug reservoir constantly releases the entrapped antibiotic over several weeks, thus allowing prolonged infection management with increased potential for resistant bacteria eradication.
For more information visit Polypid.com.
PolyPid Announces Receipt of Qualified Infectious Disease Product (QDIP) Designation from FDA for D-PLEX™ in Post-Cardiac Surgery Sternal Infection [press release]. PetachTikva, Israel: PolyPid Ltd. http://www.polypid.com/news/polypid-announces-receipt-qualified-infectious-disease-product-qidp-designation-fda-d-plex-post-cardiac-surgery-sternal-infection/. Published online March 8, 2017. Accessed on March 22, 2017