LOCALIZED DRUG DELIVERY SYSTEM STUDIED FOR PREVENTION OF SSIs

Active Ingredient: Doxycycline (broad-spectrum antibiotic)

Release Duration: Prolonged effect of 30 days

Indication: prevention of post-cardiac surgery sternal infection and post abdominal surgery incisional infection

Release profile: No burst, constant & linear release

Dosing: Varies by incision size 1vial < 10cm, 10cm < 2vials > 20cm, 3 vials >20cm

Negligible systemic exposure minimizes organ toxicity

High local concentration overcomes resistant bacteria and biofilm

Addresses area of great unmet need

INTUITIVE ADMINISTRATION ADAPTABLE TO MULTIPLE SURGERY TYPES

No additional cost or training needed

D-PLEX100 in bone tissue during open heart surgery

D-PLEX100 in Soft tissue during abdominal surgery

PHASE 2 - PREVENTION OF SURGICAL SITE INFECTION IN COLORECTAL SURGERY

Design: multicenter, controlled, randomized double-arm study

Objective: safety and efficacy of D-PLEX100 + SoC (n=101) vs. SoC alone (n=100) in prevention of incision infection post-colorectal surgery

Primary efficacy end-point: decrease of infection rate as measured by the proportion of subjects with at least one abdominal incisional infection event, as determined by a blinded and independent adjudication committee, within 30 days post abdominal surgery.

STUDY SHOWED SIGNIFICANT DECREASE IN INFECTIONS AND MORTALITY AT THE 30-DAYS PRIMARY ENDPOINT

5 deaths in the SoC treatment arm, as compared to zero in the D-PLEX100 treatment arm within the first 60 days post-surgery (p=0.029). 3 deaths observed during the first 30 days

* PEP is the Combined SSI and mortality rate which is measured by the number and proportion of subjects with either an SSI event (as determined by the abdominal surgery) or mortality or any reason within 30 days post index surgery.
Note: The current standard of care for preventing SSIs involves the implementation of a range of treatment and prevention measures before, during and after surgery, including prophylactic antibiotic administration, antiseptic measures and wound care.

PHASE 2: PREVENTION OF STERNAL INFECTIONS POST CARDIAC SURGERY

Design: single-blinded and double-arm randomized study

Objective: safety and efficacy of D-PLEX100 + SoC (n=60) vs. SoC alone (n=21) in prevention of sternal infection post-cardiac surgery

Primary efficacy endpoint: the decrease of infection rate as measured by the proportion of subjects with at least one sternal infection within 90 days post-cardiac surgery

NO STERNAL WOUND INFECTION AND NO TREATMEN RELATED SERIOUS ADVERSE EVENT IN D-PLEX100 TREATED PATIENTS

Local Effects - Sternal Wound

SoC

D-Plex100 + SoC

%

Reduction

Sternum Wound Infection rate (%)

4.3%

0%

-4.3%

Patient with sternum-wound discharge AE (%)

26.1%

8.6%

-67%

Duration of sternal discharge per patient (avg.)

1.6 days

0.7 days

-56%

Patient treated with i.v antibiotics directly duo to sternum-wound discharge AE (%)

21.7%

3.5%

-84%

General Effects

SoC

D-Plex100 + SoC

%

Reduction

Re-hospitalization - % of patients

38.1%

26.7%

-30%

Re-hospitalization - duration / patient (avg.)

7.6 days

6.6 days

-13%

Overall re-hospitalization days per patient (avg.)

2.9 days

1.8 days

-44%

-1.1 days

1 Adding vancomycin to perioperative prophylaxis decreases deep sternal wound infections in high-risk cardiac surgery patients. Reneike S. et al. European Journal of Cardio-Thoracic Surgery (2017)  2 Direct sternal administration of Vancomycin and Gentamicin during closure prevents wound infection.  Andreas M. et al. Interactive CardioVascular and Thoracic Surgery (2017)  3Prevention of surgical site sternal infections in cardiac surgery: a two-centre prospective randomized controlled study. Schimmer C et al. European Journal of Cardio-Thoracic Surgery (2016)  4Surgical Site Infections Volume-Outcome Relationship and Year-to-Year Stability of Performance Rankings. Calderwood MS. et al. Med Care 2017;55: 79–85 . 

THE LOW SYSTEMIC EXPOSURE OF D-PLEX100 SUPPORTS HIGH SAFETY PROFILE

Comparison D-PLEX100 vs. Systemic administration of Doxycycline –

minimal systemic exposure – Sternum & Abdominal

THE BURDEN OF SITE SURGICAL INFECTION

Up to 30%

Estimated SSI rate of patients undergoing colorectal surgery1,2

7-11 days

Additional post-operative hospital days for patients with SSIs

20%

SSI rate of all health care-associated infection in US hospitals

2-11x

Increased risk of death for SSI patient (up to 40% mortality after deep sternal infection)

$11k-26k

Cost of treatment per infection directly attributable to SSIs

US / EU - $10bn / ~£11bn

Estimated SSI-related incremental annual hospital costs in the US and EU

Systemic antibiotics (IV or oral) used during the course of surgery, typically beginning an hour before surgery, are not effective to prevent all SSIs

The antibiotic penetration to the surgical wound during and post operation is significantly limited because of the surgical incision and the damage to blood vessels 1,2*

Systemic antibiotics may be limited in their ability to reach the target site due to surgical disruption of local blood supply.

1 DeverickJ et al, Strategies to Prevent Surgical Site Infections in Acute Care Hospitals: 2014 Update, Infection Control and Hospital Epidemiology, 2014. 2 Estimated figures likely underestimated as ~50% of SSIs become evident only after a patient has been discharged.

Technology

PolyPid’s PLEX targeted drug delivery platform enables localized, controlled, continuous release of medication over prolonged periods of time for better patient outcomes.

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D-PLEX100

Is designed to prevent the risk of surgical site infections in both bone and soft tissue through its cutting-edge, local, extended-release mechanism

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D-PLEX1000

Comprised of antibiotic eluting ß tri-calcium phosphate (ßTCP) granules, designed for bone related infections applications.

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