PolyPid’s D-PLEX₁₀₀ Receives the US FDA’s Breakthrough Therapy Designation for the Prevention of Surgical Site Infections in Colorectal Surgery

 PolyPid’s D-PLEX₁₀₀ Receives the US FDA’s Breakthrough Therapy Designation for the Prevention of Surgical Site Infections in Colorectal Surgery

PolyPid’s D-PLEX₁₀₀ Receives the US FDA’s Breakthrough Therapy Designation for the Prevention of Surgical Site Infections in Colorectal Surgery

Shots:

  • The BTD is based on a P-II trial evaluating D-PLEX100 vs SOC alone in 201 patients for the prevention of SSIs in abdominal colorectal surgery
  • The results demonstrated a significant decrease in SSIs of 59 % in the ITT population and a decrease of 69% in the Per Protocol population
  • The ongoing P-III studies in abdominal surgery, SHIELD I and SHIELD II are on track. D-PLEX100 has received two FDA’s FTD for the prevention of post-abdominal surgery incisional infections and for the prevention of sternal wound infections post-cardiac surgery, as well as two QIDP’s in the same indications

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: PRNewswire

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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