PolyPid Announces Positive FDA Type B Meeting Feedback for D-PLEX₁₀₀ Development Program
FDA Agreed that a Single Pivotal Phase 3 Study is Sufficient for Potential Approval of D-PLEX100 for the Prevention of Surgical Site Infections in Colorectal Surgery.
- Enrollment in Phase 3 SHIELD I Trial of D-PLEX100 in Abdominal Surgery Continues to Advance; Over 200 Patients Enrolled to Date
- Top-line Results Expected by Year-end
PETAH TIKVA, Israel,
The FDA indicated that PolyPid’s proposal for a single Phase 3 pivotal study (SHIELD I), provided the study results are adequate, would provide sufficient evidence of clinical efficacy and safety to support approval of D-PLEX100 for the prevention of surgical site infections (SSIs) in colorectal surgery. The Type B meeting was requested following PolyPid’s receipt of Breakthrough Therapy Designation from the FDA for D-PLEX100 for the prevention of SSIs in patients undergoing elective colorectal surgery.
“We appreciate the thoughtful feedback from the FDA regarding our clinical program, and we are thrilled with the acceptance of our proposed development plan for the potential approval of D-PLEX100, which also reduces overall anticipated costs for the program,” said Amir Weisberg, PolyPid’s CEO. “PolyPid is dedicated to tackling the issue of SSIs that accounts for 20 percent of all healthcare-acquired infections in the
PolyPid’s lead product candidate, D-PLEX100, is a novel drug product candidate designed to provide local prolonged and controlled 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 of the drug for a period of four weeks for the prevention of SSIs, with additional potential to prevent SSIs caused by antibiotic-resistant bacteria at the surgical site. D-PLEX100 has received Breakthrough Therapy Designation from the
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act and other securities laws. Words such as “expects,” “anticipates,” “intends,” “plans,” “believes,” “seeks,” “estimates” and similar expressions or variations of such words are intended to identify forward-looking statements. For example, the Company is using forward-looking statements when it discusses its ongoing clinical trials, plans to use the guidance provided by the FDA to progress with its SHIELD I program, the timing of top-line results of the SHIELD I trial, and the size and design of the SHIELD I trial. Forward-looking statements are not historical facts, and are based upon management’s current expectations, beliefs and projections, many of which, by their nature, are inherently uncertain. Such expectations, beliefs and projections are expressed in good faith. However, there can be no assurance that management’s expectations, beliefs and projections will be achieved, and actual results may differ materially from what is expressed in or indicated by the forward-looking statements. Forward-looking statements are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in the forward-looking statements. For a more detailed description of the risks and uncertainties affecting the Company, reference is made to the Company’s reports filed from time to time with the
References and links to websites have been provided as a convenience, and the information contained on such websites is not incorporated by reference into this press release.
Dikla Czaczkes Akselbrad
EVP & CFO
Source: PolyPid Ltd.