PolyPid Unveils Expanded Pipeline Strategy, Introducing PD01B, a New Kynatrix™ Based Product Candidate for the Treatment of Diabetic Foot Infections
Globe Newswire•28/10/2026•08:00 ET
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Key Highlights
- ➤PD01B targets moderate-to-severe diabetic foot infections using localized, controlled-release doxycycline
- ➤PD01B planned as a new NDA; pre-IND meeting and first-in-human study expected in second-half 2027
- ➤D-PLEX₁₀₀ NDA remains under FDA Priority Review with November 28, 2026 PDUFA goal date
- ➤D-PLEX₁₀₀ U.S. launch expected early 2027, subject to FDA approval
- ➤D-PLEX₁₀₀ delivered 60% relative risk reduction at SHIELD II secondary endpoint
Expert Statements
Dikla Czaczkes Akselbrad, Chief Executive Officer of PolyPid
“With D-PLEX₁₀₀ approaching its Prescription Drug User Fee Act (“PDUFA”) date, a committed commercial partner in the U.S. and European rights back under our control, we are now in a position to advance other assets in our pipeline”
Dikla Czaczkes Akselbrad, Chief Executive Officer of PolyPid
“PD01B is our first step in extending Kynatrix from preventing infections to treating them. While PD01B is a distinct product, with its own formulation, indication and care setting, it is built on the Kynatrix technology that was clinically validated in our Phase 3 SHIELD II trial of D-PLEX₁₀₀, and it leverages our established CMC and manufacturing capabilities. We believe this gives PD01B a potentially accelerated, more capital-efficient path into the clinic.”
Company to host virtual Investor Day today at 11:30 AM ET, featuring key opinion leader Warren S. Joseph, DPM, FIDSA
All scheduled FDA interactions on track and aligned with D-PLEX₁₀₀ November 28, 2026 PDUFA goal date
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