PolyPid Ltd. (PYPD)
First Day Turnover71.11%
We are a Phase 3 clinical-stage biopharmaceutical company focused on developing targeted, locally administered and prolonged-release therapeutics using our proprietary Polymer-Lipid Encapsulation matriX, or PLEX, technology. Our product candidates are designed to address diseases with high unmet medical needs by pairing our PLEX technology with drugs already approved by the U.S. Food and Drug Administration, or FDA. Our PLEX technology is designed to deliver drugs directly to precise sites in the body at predetermined release rates and over durations ranging from several days to several months.
We believe that our PLEX technology and product candidates have the potential to cause a major shift in the management of a wide variety of localized medical conditions, including surgical site infections, or SSIs, cancer, inflammation and pain. Our lead product candidate, D-PLEX100, is in a potentially pivotal Phase 3 clinical trial for the prevention of sternal (bone) SSIs. We also plan to initiate the first of two potentially pivotal Phase 3 trials of D-PLEX100 for the prevention of abdominal (soft tissue) SSIs in the third quarter of 2020. We expect to report topline results from this trial at the end of 2021 and to initiate the second Phase 3 trial approximately six months after the initiation of the first trial. The World Health Organization, or WHO, estimates that SSIs result in up to $10 billion of additional hospital costs per year in the United States alone, and a further €11 billion per year in the European Union. We believe D-PLEX100, if approved, would be a significant improvement over the current standard of care, which includes systemic administration of drugs.
We believe our PLEX technology has the potential to address many of the limitations of the current standard of care of systemic administration of drugs, resulting in significantly improved patient outcomes and lower overall cost of treatment by enabling targeted and local delivery of medications at predetermined and customizable release rates and duration. The systemic administration of drugs can have significant potential disadvantages for the treatment of localized medical conditions in the body, including limited efficacy due to poor local drug concentration, which often requires the use of a considerably higher quantity of drugs over a prolonged period of time and can result in substantial side effects.
D-PLEX pairs our novel, proprietary PLEX technology with doxycycline, a first-line, broad spectrum and FDA-approved antibiotic. In our clinical trials to date, patients treated with D-PLEX demonstrated a reduction in SSIs compared to patients treated with the standard of care alone. Our lead product candidate, D-PLEX100, is currently in a potentially pivotal Phase 3 clinical trial for the prevention of SSIs in sternal (bone) surgeries, and we plan to initiate the first of two potentially pivotal Phase 3 trials of D-PLEX100 for the prevention of abdominal (soft tissue) SSIs in the third quarter of 2020.
We expect to report topline results from the first trial at the end of 2021. Infections resulting from surgery can be fatal and create a significant public health burden despite the extensive use of systemically administered antibiotics both pre- and post-operatively and other measures taken to reduce infection risk in the intra-operative setting. SSIs occur in approximately 2% to 5% of all patients undergoing inpatient surgery worldwide. The WHO and the Centers for Disease Control and Prevention, or CDC, have recently labeled SSIs as a high priority unmet medical need due to the associated morbidity, mortality and economic cost burden.
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