D-PLEX100 from Polypid for Prevention of Surgical Site Infections - Seeking a US Licensing Partner

Our client, PolyPid Ltd. (PolyPid - Optimized Therapeutics; NASDAQ:PYPD) has a patented surgical site infection (SSI) prevention product, D-PLEX100, which is presently in a Phase 3 study (SHIELD II) with a potentially study-stopping interim analysis readout in this quarter (Q4 2024) and top line results expected Q1 2025. 

We are seeking licensing/commercial partners in North America and other territories ex-Europe, where it is already licensed.

According to the CDC in USA, SSIs remain a substantial cause of morbidity, prolonged hospitalization, and mortality. SSI accounts for 20% of all Hospital Acquired Infections (HAIs) and is associated with a 2- to 11-fold increase in the risk of mortality with 75% of SSI-associated deaths directly attributable to SSI. SSI is the most costly HAI type with an estimated annual cost of $3.3 billion, and extends hospital length of stay by 9.7 days, with cost of hospitalization increased by more than $20,000 per admission. 

Consequently, there is a pressing need for new products to reduce and prevent SSIs.

D-PLEX100 is a 30-day prolonged-release paste formulation of the broad-spectrum antibiotic, doxycycline, which is applied directly to the surgical incision and will be evaluated in SHIELD II in addition to the standard of care (SoC) for prevention of SSI in abdominal colorectal surgery. In a previous Phase 3 study, SHIELD I, D-PLEX100  has shown in a pre-specified subgroup (large incisions complex surgeries) a 54% reduction (p=0.0032) in the primary endpoint of combined SSI, reintervention due to SSI and mortality. The product and the PLEX platform are protected by over 170 patents.

To establish a commercial “beachhead”, the first indication for D-PLEX100 is prevention of SSIs in abdominal colorectal surgery with the label expandable to a broader market, including abdominal surgery, gynecology and urology surgeries, cosmetic and reconstructive surgery, emergency general surgery, joint replacement surgery vascular surgery, C-section surgery and others. 

D-PLEX100 is positioned to be a competitively superior product among those presently used in conjunction with SoC in the 12 million major surgeries comprising the addressable market for D-PLEX100 in SSI prevention.

D-PLEX100 is regulated via the 505(b)2 pathway, and it has Breakthrough Therapy, Fast Track and QIDP designation; as such it has additional 5 years market exclusivity and iseligible for Medicare’s New Technology Add-on Payment (NTAP) program which reimburses up to 75% of the cost of a drug.

PolyPid has engaged The Sage Group to secure a US partner for D-PLEX100.