Latest news with #D-PLEX100
Yahoo
3 days ago
- Business
- Yahoo
PESG Research Report: Revolutionary Surgical Infection Prevention: PolyPid's D-PLEX100 Approaches Critical Phase 3 Data Readout
New report from PESG Research brand covers PolyPid*, which is tackleing the $10 billion dollar a year surgeical site infections cost with its innovative PLEX technology New York, May 30, 2025 (GLOBE NEWSWIRE) -- PESG Research is releasing a report today examining PolyPid Ltd.*, an innovative late-stage biopharmaceutical company developing revolutionary localized drug delivery technologies for surgical infection prevention. The below report explores the company's breakthrough PLEX platform technology, its upcoming topline phase 3 data, and potential implications for transforming surgical care practices in the multi-billion dollar surgical site infection prevention market. This report contains sponsored content, please see refer to the disclaimers and disclosures included at the end of this report. Executive Summary The surgical site infection (SSI) prevention landscape stands at a potential inflection point as PolyPid Ltd. prepares to announce topline results from its pivotal SHIELD II Phase 3 trial by the end of Q2 2025. The company's D-PLEX100 represents a paradigm shift in infection prevention, utilizing novel polymer-lipid encapsulation matrix (PLEX) technology to deliver sustained antibiotic release directly at surgical sites for 30 days. With SSIs affecting up to 30% of colorectal surgeries and imposing substantial healthcare costs estimated at $10 billion annually in the US and EU, successful development of D-PLEX100 could address a critical unmet medical need. The FDA's assignment of Breakthrough Therapy, Fast Track, and Qualified Infectious Disease Product (QIDP) designations underscores the regulatory recognition of this approach's potential Critical Challenge of Surgical Site Infections Surgical site infections remain one of healthcare's most persistent challenges, representing 20% of all healthcare-associated infections in US hospitals. Despite advances in surgical techniques and prophylactic protocols, SSI rates in high-risk procedures like colorectal surgery can reach 30%, leading to extended hospital stays of 7-11 additional days and mortality risk increases of 2-11 fold. The economic burden is staggering, with direct costs averaging $11,000-26,000 per infection and total annual costs reaching approximately $10 billion in the US alone. Current prevention strategies rely primarily on systemic antibiotic prophylaxis administered intravenously 30-60 minutes before surgery. However, this approach faces fundamental limitations. Surgical incisions disrupt local blood flow, significantly limiting antibiotic penetration to the precise site where infections occur. Moreover, systemic administration exposes patients to higher drug concentrations throughout the body, potentially increasing toxicity risks and contributing to antimicrobial resistance development. PLEX Technology: A Novel Approach to Localized Drug Delivery PolyPid's proprietary PLEX technology represents a sophisticated advancement in controlled drug delivery systems. The platform creates thousands of alternating layers of biocompatible polymers and lipids that physically embed active pharmaceutical ingredients. As these outer layers gradually disintegrate upon exposure to body fluids, they enable precise, predetermined drug release rates spanning several days to months. For D-PLEX100, this technology pairs with doxycycline, a broad-spectrum antibiotic effective against both gram-positive and gram-negative bacteria, including methicillin-resistant Staphylococcus aureus (MRSA) and other antibiotic-resistant strains. The formulation achieves local antibiotic concentrations 10-115 times higher than systemic administration while using only a fraction of the total drug amount, potentially minimizing systemic exposure and associated side effects. Clinical Development Progress and Regulatory Recognition The clinical development program for D-PLEX100 has demonstrated encouraging signals across multiple surgical contexts. In Phase 2 abdominal surgery trials, D-PLEX100 plus standard of care achieved a statistically significant 59% reduction in the primary endpoint compared to standard of care alone (p=0.0086). Perhaps more notably, the treatment group experienced zero deaths compared to five in the control arm within 60 days post-surgery. The pivotal SHIELD I Phase 3 trial, while not meeting its primary endpoint in the full intent-to-treat population, revealed compelling efficacy in a pre-specified subgroup analysis. Among patients with large surgical incisions (>20 cm), D-PLEX100 demonstrated a statistically significant 54% reduction in the composite primary endpoint of SSIs, reinterventions, and mortality (p=0.0032). This finding directly informed the design of the ongoing SHIELD II trial, which focuses specifically on this higher-risk patient FDA's regulatory designations reflect recognition of D-PLEX100's potential significance. Breakthrough Therapy designation is reserved for drugs that demonstrate substantial improvement over existing treatments for serious conditions. Fast Track designation facilitates more frequent FDA communications and potentially accelerated review timelines. The QIDP designation provides additional market exclusivity incentives for addressing antimicrobial resistance challenges. SHIELD II: A Potentially Definitive Study The ongoing SHIELD II Phase 3 trial represents a carefully designed study incorporating lessons learned from SHIELD I. Following an independent Data Safety Monitoring Board's review of unblinded efficacy data from the first 430 enrolled patients, the board recommended concluding the study at 800 patients—the lowest sample size reassessment option available. This recommendation, while requiring additional enrollment beyond the initially planned 624 patients, may suggest positive efficacy trends in the analyzed interim data. The study's multinational design spans approximately 60 centers across the United States, Europe, and Israel, enhancing the generalizability of results across different healthcare settings and patient populations. The primary endpoint focuses on a composite of SSI events, reinterventions, and mortality within 30 days post-surgery, as adjudicated by an independent committee. Broader Industry ImplicationsSuccess of D-PLEX100 could catalyze broader adoption of localized drug delivery approaches in surgical settings. The technology's platform nature suggests potential applications beyond infection prevention, including localized chemotherapy delivery through the company's OncoPLEX program, currently in preclinical development for solid tumor treatment. The substantial market opportunity—with approximately 12 million eligible procedures annually in the US and 8 million in Europe—underscores the potential healthcare impact. PolyPid has already secured European commercialization rights through a partnership with Advanz Pharma, valued at up to $115 million plus royalties, while advancing discussions for US market partnerships. Conclusion As the pharmaceutical industry grapples with antimicrobial resistance and healthcare systems seek cost-effective solutions to persistent clinical challenges, D-PLEX100's approaching data readout represents a potentially significant milestone. The convergence of compelling preclinical and early clinical data, regulatory recognition, and substantial unmet medical need positions this development as one to monitor closely in the evolving landscape of surgical infection News Highlight from PolyPid: PolyPid Announces Successful Completion of Enrollment in Phase 3 SHIELD II Trial of D-PLEX₁₀₀ for the Prevention of Abdominal Colorectal Surgical Site Infections >> Click here to Subscribe for more updates like this or go to * Legal Disclaimer & Disclosure: Nothing in this report constitutes medical, financial or any form professional or licensedadvice. This report is published by 'PESG Research', a digital promotional content brand who's operators are compensated to provide digestable and favorabel coverage of companies. This report contains and is a form of paid promotional content or advertising for PolyPid Ltd and was produced as part of the fee's they pay PESG's operators, Arx Advisory Ltd. This report has not been reviewed or approved by PolyPId prior to publication and it does not represent an official communication from PolyPid. The operators of PESG Research received or are expected to receive a monthly recurring fee of five thousand united states dollars via wire transfer from PolyPid as part of an ongoing agreement starting May 1, 2025 in return for distribution and promotional coverage services, and receive additional monthly compensation for non promotional unrelated data and advisory services on top of that. Please review the full disclaimers and compensation disclosures here for further details: Readers are advised to refer to the official materials of the company aforementioned. The report should not be treated as objective.
Yahoo
03-03-2025
- Business
- Yahoo
PolyPid to Participate in the 37th Annual ROTH Conference
PETACH TIKVA, Israel, March 03, 2025 (GLOBE NEWSWIRE) -- PolyPid Ltd. (Nasdaq: PYPD), ('PolyPid' or the 'Company'), a late-stage biopharma company aiming to improve surgical outcomes, today announced that the Company's management will present at the 37th Annual ROTH Conference taking place in Dana Point, California, from March 17-18, 2025. PolyPid's fireside chat will be available on-demand beginning on Monday, March 17, 2025, at 2:00 PM PT via the conference platform using the following link. The PolyPid management team will participate in one-on-one investor meetings during this event. Investors interested in meeting with PolyPid around the conference should contact their ROTH representative. About PolyPid PolyPid Ltd. (Nasdaq: PYPD) is a late-stage biopharma company aiming to improve surgical outcomes. Through locally administered, controlled, prolonged-release therapeutics, PolyPid's proprietary PLEX (Polymer-Lipid Encapsulation matriX) technology pairs with Active Pharmaceutical Ingredients (APIs), enabling precise delivery of drugs at optimal release rates over durations ranging from several days to months. PolyPid's lead product candidate D-PLEX100 is in Phase 3 clinical trial for the prevention of abdominal colorectal surgical site infections. In addition, the Company is currently in preclinical stages to test the efficacy of OncoPLEX for the treatment of solid tumors, beginning with glioblastoma. For additional Company information, please visit and follow us on Twitter and LinkedIn. Contacts: PolyPid Ltd. Ori Warshavsky COO – US 908-858-5995 IR@ Investors: Brian Ritchie LifeSci Advisors 212-915-2578 britchie@ in to access your portfolio
Yahoo
30-01-2025
- Business
- Yahoo
PolyPid to Participate in the Oppenheimer 35th Annual Healthcare Life Sciences Conference
PETACH TIKVA, Israel, Jan. 30, 2025 (GLOBE NEWSWIRE) -- PolyPid Ltd. (Nasdaq: PYPD), ('PolyPid' or the 'Company'), a late-stage biopharma company aiming to improve surgical outcomes, today announced that the Company's management will present at the Oppenheimer 35th Annual Healthcare Life Sciences Conference taking place virtually on February 11 - 12, 2025. Oppenheimer 35th Annual Healthcare Life Sciences Conference PolyPid's presentation will be available on-demand beginning on Wednesday, February 12, 2025 at 11:20 AM Eastern Time and for 365 days after via the conference platform or using the following link. The PolyPid management team will participate in one-on-one investor meetings during this event. Investors interested in meeting with PolyPid at the conference should contact their Oppenheimer representative. About PolyPid PolyPid Ltd. (Nasdaq: PYPD) is a late-stage biopharma company aiming to improve surgical outcomes. Through locally administered, controlled, prolonged-release therapeutics, PolyPid's proprietary PLEX (Polymer-Lipid Encapsulation matriX) technology pairs with Active Pharmaceutical Ingredients (APIs), enabling precise delivery of drugs at optimal release rates over durations ranging from several days to months. PolyPid's lead product candidate D-PLEX100 is in Phase 3 clinical trial for the prevention of abdominal colorectal surgical site infections. In addition, the Company is currently in preclinical stages to test the efficacy of OncoPLEX for the treatment of solid tumors, beginning with glioblastoma. For additional Company information, please visit and follow us on Twitter and LinkedIn. Contacts: PolyPid Ltd. Ori Warshavsky COO – US 908-858-5995 IR@ Investors: Brian Ritchie LifeSci Advisors 212-915-2578 britchie@
Yahoo
29-01-2025
- Business
- Yahoo
PolyPid to Report Fourth Quarter and Full-Year 2024 Financial Results and Operational Highlights on February 12, 2025
PETACH TIKVA, Israel, Jan. 29, 2025 (GLOBE NEWSWIRE) -- PolyPid Ltd. (Nasdaq: PYPD) ('PolyPid' or the 'Company'), a late-stage biopharma company aiming to improve surgical outcomes, today announced that it will report its fourth quarter and full-year 2024 financial results and operational highlights before the open of the U.S. financial markets on Wednesday, February 12, 2025. The Company will host a conference call and webcast at 8:30 AM Eastern Time to discuss the results and provide an update on business operations. To ensure you are connected prior to the beginning of the call, PolyPid suggests registering a minimum of 5 minutes before the start of the call. For those not planning to ask a question of management, the Company recommends listening via the webcast. Conference Call Dial-In & Webcast Information: Date: Wednesday, February 12, 2025 Time: 8:30 AM Eastern Time Conference Call: Webcast About PolyPidPolyPid Ltd. (Nasdaq: PYPD) is a late-stage biopharma company aiming to improve surgical outcomes. Through locally administered, controlled, prolonged-release therapeutics, PolyPid's proprietary PLEX (Polymer-Lipid Encapsulation matriX) technology pairs with Active Pharmaceutical Ingredients (APIs), enabling precise delivery of drugs at optimal release rates over durations ranging from several days to months. PolyPid's lead product candidate D-PLEX100 is in Phase 3 clinical trial for the prevention of abdominal colorectal surgical site infections. In addition, the Company is currently in preclinical stages to test the efficacy of OncoPLEX for the treatment of solid tumors, beginning with glioblastoma. For additional Company information, please visit and follow us on Twitter and LinkedIn. 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. PolyPid is not responsible for the contents of third-party websites. Contacts: PolyPid Ltd. Ori WarshavskyCOO – US908-858-5995IR@ Investors:Brian RitchieLifeSci Advisors212-915-2578Britchie@
