D-PLEX is PolyPid’s lead product candidate from PLEX-doxycycline family, which is being developed to manage bone and soft tissue SSIs.
D-PLEX™ is a secured antibiotic drug reservoir that provides a safe and effective local anti-bacterial preventive measure as well as eradication at the needed tissues or organs by administration during surgical procedures. After surgery the reservoir constantly releases the entrapped antibiotic over several weeks. In doing so, the D-PLEX™ reservoir allows for prolonged infection prevention or treatment and also has the potential to eradicate resistant bacteria, which was classified by the US government as a serious global threat1.
PolyPid recently completed patient enrollment of a Phase 1b/2 clinical trial of D-PLEX for the prevention of sternal SSIs after cardiac surgery.
D-PLEX received QIDP designation from the FDA in February 2017 for the prevention of sternal infection after cardiac surgery. The QIDP program is designed to expedite the development of novel drugs against important pathogens.
PolyPid also plan to commence a Phase 2 trial of D-PLEX for the prevention of SSIs, to be conducted in patients undergoing abdominal surgery for the prevention of SSIs in the first half of 2018.
D-PLEX™ is not yet approved for sale by regulatory agencies
(1) The White House: Executive Order — Combating Antibiotic-Resistant Bacteria, Sep 18, 2014
D-PLEX™ formulation is well organized on a molecular level as a fine, sub-structure by self-assembly into PLEX™
Less than one daily dose for 30 days is sufficient to achieve a significant therapeutic effect
D-PLEX is designed to release a small antibiotic dose constantly for at least three to four weeks,
with the overall accumulated dose being equal to about 1% of a 30 day oral antibiotic regimen.
Preparation and use of D-PLEX product candidate in open heart surgery
D-PLEX is to be used in conjunction with standard of care in open heart surgeries.
By combining doxycycline with our proprietary PLEX technology, D-PLEX has the potential to overcome the limitations of other available treatments and deliver significant advantages in the management of SSIs, including:
- Localized delivery of an antibiotic at therapeutically effective concentrations for up to four weeks;
- Applicability to a wide range of bacteria in a variety of settings;
- Activity against MRSA and community-associated MRSA strains;
- Increased penetration and access to the infection site;
- Reduced risk of overall toxicity and adverse side effects due to minimization of systemic exposure and significant decrease of total drug volume delivered;
- Fully biodegradable; no need to remove the product after the drug reservoir is depleted;
- Simplicity of administration during surgery; and
- Reduction of patient compliance concerns.
SURGICAL SITE INFECTIONS (SSI)
While advances have been made in infection control practices, including improved operating room ventilation, sterilization methods, barriers, surgical technique, and availability of antimicrobial prophylaxis, SSIs remain a substantial cause of morbidity, prolonged hospitalization, and death. SSI are the second most common hospital acquired infections in United States and the European Union and occur in approximately 2% to 5% of patients undergoing inpatient surgery worldwide1. SSIs might result in1,2:
- Increased length of post operative hospital stay by 7-10 days
- Directly attributable costs of SSIs range from $11,000 to $26,000 per infection.
- In more complex infections involving a prosthetic joint or antimicrobial-resistant organism, the cost per case can exceed $90,000.
- Two - 11 times increased risk of death compared to infection free patients
- $10 billion of incremental hosptal costs per year in US and ~7 billion per year in European union.
Current systemic antibacterial solutions are not sufficiently effective due to low target penetration. The insufficient penetration is either temporary due to surgery related trauma to the tissue, or constant due to the nature of the target area.