PolyPid Completes Enrollment of Phase 2 Clinical Trial with D-PLEX100 in Abdominal Surgery
PETAH TIKVA, Israel, Aug. 12, 2019 /PRNewswire/ -- PolyPid Ltd., a clinical-stage biopharmaceutical company focused on developing and commercializing novel, locally administered therapies, announced today that it has completed patient enrollment of 200 patients in its Phase 2 clinical trial evaluating D-PLEX100 for the prevention of post-abdominal surgery incisional site infections.
PolyPid previously reported that the trial was planned to enroll up to 300 patients undergoing elective colorectal surgery. The Phase 2 trial design included a pre-planned blinded sample size re-estimation. When the re-estimation was conducted, it indicated that the trial can be completed after enrollment of only 200 patients.
The Phase 2 clinical trial, initiated on October 2018, is a prospective, multicenter, randomized, controlled, single-blind, two arm study to assess the safety and efficacy of D-PLEX100 administered concomitantly with the Standard of Care (SOC), compared to SOC treated control arm, in the prevention of post-abdominal surgery incisional infection (superficial and deep) over a period of 30 days.
"Abdominal surgeries, and especially those involving colorectal resection, are known to be associated with the highest rate of surgical site infections (SSI) among all elective surgical procedures," said Amir Weisberg, PolyPid's CEO. "We believe that D-PLEX100 has the potential to radically transform the prevention of SSIs, and we look forward to reporting top-line data from this study by the end of October 2019."
More information on the trial can be found at: https://clinicaltrials.gov/ct2/show/NCT03633123?term=D-PLEX&rank=3
PolyPid's lead drug product candidate, D-PLEX100, is a novel product designed to provide local and 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 the prolonged and constant release of broad-spectrum antibiotic that generates high local concentration of the antibiotics for a period of four weeks, thus allowing effective prevention of infection after surgery with increased potential to eradicate antibiotic resistant bacteria. D-PLEX100 has received two 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 clinical stage biopharmaceutical company focused on developing and commercializing novel, locally administered therapies using its transformational PLEX (Polymer-Lipid Encapsulation Matrix) technology to treat a wide variety of localized medical conditions with an initial focus on the management of surgical site infections. PLEX-based products have demonstrated an excellent efficacy and safety profile during extended clinical trials. More than 200 patients have been treated in clinical trials to date. PolyPid's technology and products are based on the inventions of Dr. Noam Emanuel, the Founder and the Chief Scientific Officer of the company.
For additional company information, visit www.polypid.com.
Forward looking Statement
This press release contains projections and other forward-looking statements regarding future events or our future financial performance. All statements other than present and historical facts and conditions contained in this release, including any statements regarding our future results of operations and financial positions, business strategy, plans and our objectives for future operations, are forward-looking statements (within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended). These statements are only predictions and reflect our current beliefs and expectations with respect to future events and are based on assumptions and subject to risk and uncertainties and subject to change at any time. Actual events or results may differ materially from those contained in the projections or forward-looking statements. Forward-looking statements in this release are made pursuant to the safe harbor provisions contained in the Private Securities Litigation Reform Act of 1995.
Dikla Czaczkes Akselbrad
Chief Financial Officer
SOURCE PolyPid Ltd.