PETAH TIKVA, Israel, Feb. 27, 2020 /PRNewswire/ -- PolyPid Ltd., a Phase 3 clinical-stage biopharmaceutical company focused on developing targeted, locally administered and prolonged-release therapeutics using its proprietary PLEX technology, today announced that the first patient has been enrolled and randomized in a Phase 3 clinical trial called SHIELD (Surgical site Hospital acquired Infection prEvention with Local D-plex). SHIELD will evaluate D-PLEX100 plus the standard of care (SoC) versus SoC only for the prevention of sternal wound infection post-cardiac surgery. Juan A. Crestanello, M.D., a cardiovascular and thoracic surgeon at Mayo Clinic, is the Principal Investigator of the SHIELD study.
"The initiation of this Phase 3 clinical trial represents a significant milestone for our D-PLEX100 development program," said Amir Weisberg, PolyPid's CEO. "Cardiac surgery is a key bone surgical model for D-PLEX100. We believe that this trial, combined with our previously received Qualified Infectious Disease Product (QIDP) and Fast Track designations for the prevention of sternal wound infection post-cardiac surgery from the U.S. Food and Drug Administration, represents a key advancement toward our U.S. regulatory approval strategy and our ability to provide a novel solution for surgeons and their patients as expeditiously as possible."
SHIELD is a prospective, multinational, multicenter, blinded, randomized study designed to assess the efficacy and safety of D-PLEX100 in the prevention of sternal wound infection post-cardiac surgery. The primary endpoint of the trial is the infection rate as measured by the proportion of subjects with a sternal wound infection event within 90 days post-sternotomy. The trial will enroll a minimum of 1,284 subjects, with a maximum of about 1,600 subjects, as defined by the adaptive study design, in approximately 45 centers in the U.S., Europe and Israel.
PolyPid previously completed a single-blinded and double-arm randomized Phase 1b/2 trial evaluating the safety and efficacy of D‐PLEX100 plus SoC versus SoC only in the prevention of sternal wound infection post-cardiac surgery. In this trial, none of the 58 patients treated with D‐PLEX100 plus SoC had a primary sternal wound infection within 90 days post-surgery, as compared to one of the 23 patients in the SoC arm, representing a 4.3% infection rate. In addition, in the D‐PLEX100 plus SoC arm, 3.4% of patients were treated with IV antibiotics directly due to a sternum wound discharge adverse event, as compared to 21.7% in the SoC only group. D‐PLEX100 was observed to be generally well tolerated, with no drug-related severe adverse effects and no drug-related wound healing issues at the incision site.
PolyPid's lead drug product candidate, D-PLEX100, is a novel product designed to provide local prolonged anti-bacterial activity directly at the surgical site to prevent SSIs. Following the administration of D-PLEX100 into the surgical site, the PLEX technology enables a prolonged and constant release of the broad-spectrum antibiotic, doxycycline, resulting in high local concentration for a period of four weeks for the prevention of SSIs, with additional potential to treat antibiotic-resistant bacteria at the surgical site. D-PLEX100 has received two Qualified Infectious Disease Product (QIDP) designations from the FDA for the prevention of sternal wound infection post-cardiac surgery and for the prevention of post-abdominal surgery incisional infection.
PolyPid is a Phase 3 clinical-stage biopharmaceutical company focused on developing targeted, locally administered and prolonged-release therapeutics using its proprietary PLEX (Polymer-Lipid Encapsulation matriX) technology. PolyPid's product candidates are designed to address diseases with high unmet medical needs by pairing PLEX with drugs already approved by the FDA to deliver drugs directly to precise sites in the body at predetermined release rates and over durations ranging from several days to several months. PolyPid's lead product candidate, D-PLEX100, is in a Phase 3 clinical trial for the prevention of sternal SSIs. PolyPid's technology and products are based on the inventions of Dr. Noam Emanuel, the Founder and the Chief Scientific Officer of the company.
Cautionary Statement Regarding Forward-Looking Statements
Statements made in this press release that are not historical facts are forward-looking statements. Words such as "expects," "believes," "intends," "hope," "forward" and similar expressions are intended to identify forward-looking statements. Examples of forward-looking statements in this press release include, among others, statements about PolyPid's plans, objectives and intentions with respect to D-PLEX100 and the PLEX platform, including statements related to the timing, trial design and conduct of clinical trials. Forward-looking statements involve substantial risks and uncertainties that could cause actual results to differ materially from those projected in any forward-looking statement. You should not place undue reliance on any forward-looking statements. PolyPid assumes no obligation to update any forward-looking statements, even if expectations change.
For additional company information, visit www.polypid.com.
Dikla Czaczkes Akselbrad
Chief Financial Officer
Bob Yedid, Managing Director
Alison Chen, Account Supervisor
SOURCE PolyPid Ltd.