Photo: PolyPid (cropped)
Petach Tikva-based PolyPid unveiled a new antibiotic drug candidate Wednesday, expanding its pipeline from preventing surgical infections to treating diabetic foot infections.
The candidate, PD01B, combines the antibiotic doxycycline with the company’s Kynatrix delivery technology. PolyPid said it is designed to be applied directly into an infected wound after debridement, the removal of damaged tissue, and to release the antibiotic locally over a period of weeks.
The company’s October 28 announcement sets out an early development plan, not clinical evidence that PD01B works in patients. PolyPid expects both a pre-investigational new drug meeting with the U.S. Food and Drug Administration and a first-in-human study in the second half of 2027.
A new treatment target
PD01B is being developed for moderate-to-severe diabetic foot infections. PolyPid says local delivery is intended to concentrate doxycycline at the infection site, where poor blood supply can make treatment difficult. Those intended benefits still need to be tested for this candidate.
The company plans to develop PD01B through a separate New Drug Application. It is a distinct product from D-PLEX100, PolyPid’s lead candidate for preventing infections at abdominal surgical sites, even though both use the company’s drug-delivery technology.
A separate FDA deadline approaches
D-PLEX100 is under FDA Priority Review, with a November 28, 2026 target date for an agency decision. A review deadline is not an approval.
PolyPid expects a U.S. launch in early 2027 only if the FDA approves D-PLEX100. The company also identified potential additional surgical uses and geographic expansion as parts of its longer-term plan, subject to further regulatory steps.
For PD01B, the next milestones remain the planned FDA discussion and first human study in 2027. Wednesday’s pipeline announcement does not make the candidate an approved or available treatment.
JBizNews Desk | Israel
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