Policy & Regulation
PolyPid begins first phase three clinical trial of D-PLEX100
2 July 2020 -

PolyPid Ltd (Nasdaq: PYPD), an Israel-based biopharmaceutical company, has enrolled and randomised the first patient in the SHIELD I (Surgical site Hospital acquired Infection prEvention with Local D-plex) trial of D-PLEX100, it was reported on Wednesday.

The trial is the firm's first of the two phase three clinical trials of its lead product candidate, D-PLEX100, intended for the prevention of post-abdominal surgery incisional infection (soft tissue). It is a multinational, multicentre, randomised, double blind Phase three trial aimed at evaluating the efficacy and safety of D-PLEX100 administered concomitantly with the Standard of Care, compared to a Standard of Care-treated control arm, for the prevention of post-abdominal surgery incisional infection.

The product is a novel product candidate aimed at offering local prolonged anti-bacterial activity directly at the surgical site to prevent surgical site infections. The Food and Drug Administration (FDA) has granted the product two Qualified Infectious Disease Product designations, which include prevention of sternal wound infection post-cardiac surgery, and the prevention of post-abdominal surgery incisional infection.

The trial will enrol a minimum of 616 patients, with a maximum of about 900 patients, as defined by the adaptive study design, in approximately 50 centres in the United States, Europe and Israel.

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