Protara gets FDA clearance to start Phase 2 STARBORN-1 trial of TARA-002 for pediatric lymphatic malformations

Protara Therapeutics, Inc.

FDA cleared the Phase 2 STARBORN-1 trial of TARA-002 (cell-based immunopotentiator) in pediatric patients with lymphatic malformations.
Trial is single-arm, open-label, enrolling ~30 patients aged 6 months to <18 years; primary endpoint is clinical success (≥60% volume reduction).
TARA-002 previously granted Rare Pediatric Disease designation by FDA; trial initiation expected in Q4 2023.
Predecessor therapy OK-432 is approved in Japan and Taiwan and was studied in a U.S. compassionate-use program of over 500 patients.

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