Antibiotic Reservoir Device Could Improve Heart Surgery Outcomes
D-PLEX prevented infections among patients who received open heart surgery.
PolyPid, a specialty pharmaceutical company, recently announced that their investigational drug D-PLEX (Doxycycline/Polymer-Lipid Encapsulation Matrix) was designated as a qualified infectious disease product (QIDP) by the FDA.
D-PLEX is an investigational antibiotic drug reservoir that provides continuous anti-bacterial prevention and treatment for patients undergoing surgical procedures, according to a press release. After surgery, the reservoir releases antibiotics over several weeks to provide prolonged infection control, and may fight resistant bacteria.
Post-cardiac surgery sternal infection is currently a clinically unmet need, and presents a significant complication that can occur for many patients after open heart surgery. On its own, open heart surgery carries a high mortality rate. When coupled with infection, patients are likely to experience poor health outcomes and higher costs.
In an ongoing phase 1b/2 clinical trial, investigators found that patients that used D-PLEX were infection-free during 3 months of follow up. D-PLEX was observed to be safe and elicit no adverse events, according to the press release.
According to PolyPid, surgical site infections can increase hospital stays by 7 to 10 days, increase costs by up to $30,000, increase readmission, increase mortality risk approximately 10%, and add an additional $10 billion to healthcare spending. Preventing infection is important among surgical patients, especially those undergoing open heart surgery.
The QIDP designation was developed to incentivize manufacturers to create novel drugs against pathogens. Under this designation, D-PLEX will receive priority review, eligibility for fast track designation, and 5 years of market exclusivity upon approval.
PolyPid is currently planning to conduct a phase 3 trial in these patients, and is awaiting regulatory approval for the studies. In a pre-investigational new drug application meeting with the FDA, the agency said D-PLEX would be able to move into phase 3 testing in the United States due to the positive study results, according to the release.
The approval of D-PLEX would present patients undergoing open heart surgery with an effective approach to prevent potentially life-threatening infections. A benefit of the reservoir is that patients do not have to remember to adhere to medications, which could present a vulnerability to certain patients.
“The receipt of QIDP designation from the FDA represents an important milestone that expedites and extends the commercial path for D-PLEX™ in the US,” said Amir Weisberg, chief executive officer, PolyPid. “We view this QIDP designation as validation of the significant potential of D-PLEX™ in preventing and treating surgical site infections. We look forward to the availability of additional data by year-end 2017 from our ongoing Phase Ib/II study in Israel of D-PLEX in post-cardiac surgery sternal infection.”