Protara Therapeutics Announces Positive Interim Results Demonstrating Robust Responses in the Ongoing Phase 2 STARBORN-1 Trial of TARA-002 in Pediatric Patients with Lymphatic Malformations

Core Insights - Protara Therapeutics announced positive interim results from the Phase 2 STARBORN-1 trial for TARA-002, a cell-based therapy for pediatric patients with lymphatic malformations (LMs) [1][2] STARBORN-1 Interim Results - The interim analysis included 12 patients, with 8 evaluable at the eight-week post-treatment assessment; 7 out of 8 achieved clinical success [3][5] - The majority of patients (80%) who completed treatment and all patients (100%) who completed the eight-week assessment achieved clinical success [5][6] - 83% of macrocystic patients achieved a complete response, with one patient achieving a substantial response [6] Safety Profile - Adverse events were mostly mild to moderate, with no serious adverse events reported; common adverse events included swelling and fatigue [4][5] - One patient discontinued treatment due to a Grade 2 adverse event of fatigue [4] About TARA-002 - TARA-002 is a genetically distinct strain of streptococcus pyogenes, developed from the same master cell bank as OK-432, which has been the standard of care for LMs in Japan for 30 years [9] - TARA-002 has received Rare Pediatric Disease designation from the FDA for the treatment of LMs [9] About Lymphatic Malformations - Lymphatic malformations are rare congenital conditions, primarily affecting the head and neck, with significant morbidity including airway obstruction and recurrent infections [10] Company Overview - Protara Therapeutics is a clinical-stage biotechnology company focused on developing transformative therapies for cancer and rare diseases, including TARA-002 for LMs and non-muscle invasive bladder cancer [11]