Protara receive regulatory clearance from FDA to start Phase 2 STARBORN-1 trial

Protara Therapeutics announced that it has received regulatory clearance from the U.S. Food and Drug Administration, FDA, on its planned Phase 2 STARBORN-1 trial evaluating TARA-002, an investigational cell-based immunopotentiator, for the treatment of pediatric patients with lymphatic malformations. Trial initiation is expected in the fourth quarter of 2023. "There are currently no FDA-approved treatments for LMs, a rare, serious condition mostly affecting children," said Jesse Shefferman, Chief Executive Officer of Protara Therapeutics. "We are pleased to take the next step on our journey to deliver TARA-002 to these young patients and look forward to initiating this Phase 2 trial in pediatric patients with LMs." STARBORN-1 is a Phase 2 single-arm, open-label, prospective clinical trial to evaluate the safety and efficacy of intracystic injection of TARA-002 for the treatment of macrocystic and mixed cystic LMs in participants six months to less than 18 years of age. Following completion of an age de-escalation safety lead-in, the trial will enroll approximately 30 patients who will receive up to four injections of TARA-002 spaced approximately six weeks apart. The primary endpoint of the trial is the proportion of participants with macrocystic LMs and mixed cystic LMs who demonstrated clinical success, defined as having either a complete response or substantial response eight weeks after the last injection, as measured by axial imaging.