PolyPid Ltd. (Nasdaq: PYPD), a late-stage biopharma company, has announced that the first patient has been recruited for its revised SHIELD II Phase 3 trial, an exciting advancement in improving surgical outcomes. This trial will evaluate the use of D-PLEX100 for the prevention of abdominal colorectal surgical site infections (SSIs).
The FDA recently accepted the revised protocol for the trial, which will recruit an estimated 550 patients and have top-line results expected by mid-2024. Additionally, an interim analysis of 400 patients is planned once they complete their 30-day follow-up. With this breakthrough, PolyPid aims to revolutionize the healthcare sector and provide better outcomes for patients.
PolyPid is delighted to announce that the revised version of their late-stage D-PLEX100 development program trial, SHIELD II, has successfully recruited its first patient. SHIELD I had previously demonstrated a highly statistically significant reduction of 54% in surgical site infections in patients undergoing surgeries with large incisions.
As an effort to provide more security to this trial, SHIELD II will primarily be conducted in the most successful sites of SHIELD I, in terms of recruitment, patient monitoring and guaranteed clinical practice. PolyPid is excited to resume the trial and has bolstered their internal clinical operations capacity to ensure that SHIELD II progresses in a successful manner. Further updates on the trial’s progress will be made available in the near future.
About SHIELD II
Shield II is a groundbreaking Phase 3 clinical trial that aims to evaluate the efficacy and safety of D-PLEX100 as an additional preventive measure for post-abdominal surgery infection in patients undergoing incisions longer than 20 cm. Using a randomized, double-blind and multinational study model, Shield II will be measuring its primary endpoint – the proportion of subjects with surgical site infection, reintervention, or mortality within 30 days after their surgery – and track safety for an additional 30 days. Patients enrolled in the trial will come from medical centers in the United States, Europe, and Israel. Shield II is an exciting clinical study that could revolutionize how post-surgical infections are prevented.
PolyPid Ltd. (Nasdaq: PYPD) is a biopharma company taking strides to revolutionize the world of surgical outcomes. With its advanced PLEX (Polymer-Lipid Encapsulation matriX) technology, the company has created an innovative, locally administered, controlled, and prolonged-release therapeutic which couples Active Pharmaceutical Ingredients (APIs) to deliver the right drugs in the right amount at the right time.
D-PLEX100, PolyPid’s lead product candidate, is currently in Phase 3 clinical trial for the prevention of abdominal colorectal surgical site infections and the company is also working on OncoPLEX, a preclinical product for the treatment of solid tumors such as glioblastoma. With PolyPid’s revolutionary development, there is hope of improved surgical outcomes in the near future.
Our company has made forward-looking statements regarding the development and potential of D-PLEX100’s ability to help prevent SSIs, the total recruitment and timing for the SHIELD II Phase 3 trial, the effectiveness of measures to de-risk the trial and the timing of expected top-line results and potential unblinded interim analysis. We believe these statements are made in good faith to express our optimism for the impact of D-PLEX100 and the success of our trial.
There are, however, certain risks and uncertainties that may lead to actual results that differ from our expectations. Therefore, we make no assurance or guarantee that our expectations, beliefs, and projections will be achieved. This is why we consistently assess and manage risks to provide the highest quality data in our trials. To learn more about the risks and uncertainties of our business, please refer to our periodic SEC filings. We will keep you informed with updates on our progress and the results of our trials.