News & Events zu Protara Therapeutics Inc (TARA)TARAProtara Therapeutics Inc

Protara Advances TARA-002 Clinical Trials

"Protara continues to deliver across our late-stage portfolio, advancing each of our programs toward its next key clinical and regulatory milestone. This steady progress positions us to close out the year with strong momentum and sets the stage for an impactful 2027," said Jesse Shefferman, Chief Executive Officer at Protara Therapeutics. "TARA-002 has the potential to be a preferred treatment option for patients with non-muscle invasive bladder cancer, and we are on track to complete enrollment of the BCG-Unresponsive registrational cohort by year-end, a key step toward bringing this therapy to patients. Following quarter end, we also entered into a purchase agreement for TARA-002 manufacturing-related assets from Novex Innovations, LLC, our clinical supply partner since 2019. We are excited to bring this manufacturing capability in-house as we advance our late-stage clinical trials and prepare to launch TARA-002 in lymphatic malformations and NMIBC."

Protara Therapeutics Strengthens TARA-002 Development Progress

"In the second quarter, we strengthened our late-stage pipeline through continued operational execution, positioning us for multiple important milestones over the coming quarters," said Jesse Shefferman, Chief Executive Officer at Protara Therapeutics. "We continue to make progress in the ADVANCED-2 trial and expect to complete enrollment in the fourth quarter of 2026. We remain confident that TARA-002 will be a preferred treatment option in the non-muscle invasive bladder cancer (NMIBC) BCG-Unresponsive setting, and we are redesigning ADVANCED-3 to be a multi-cohort, open-label, exploratory trial, which will allow us to study TARA-002 in a broader high-grade, high-risk NMIBC patient population. The redesigned ADVANCED-3 protocol is expected to accelerate and expand the breadth of data available at or around the time of the potential launch of TARA-002 in BCG-Unresponsive carcinoma in situ patients."

Protara Updates TARA-002 Clinical Data

Protara Therapeutics announced updated 12-month data from Cohort A of the ongoing Phase 2 open-label ADVANCED-2 trial of TARA-002 in patients with carcinoma in situ or CIS non-muscle invasive bladder cancer. These results in Bacillus Calmette-Guerin-Naive NMIBC patients will be featured today during a poster session at the American Urological Association annual meeting in Washington, D.C. The BCG-Naive dataset includes a total of 31 patients of whom 29 were evaluable for efficacy, with 27 patients evaluable at six months and 20 patients evaluable at 12 months, as of an April 5 data cutoff. The CR rate at any time in BCG-Naive patients was 72.4%. The CR rate in BCG-Naive patients was 66.7% at six months and 55% at 12 months. The Kaplan-Meier estimated probability of maintaining a CR for six months was 73.1%. Overall, 91.7% maintained their CR from nine to 12 months. Overall, 66.7% of re-induced patients converted to a CR at six months. The majority of treatment-related adverse events were Grade 1 and transient, with no Grade 3 or greater TRAEs reported, as assessed by study investigators. No patients discontinued treatment due to TRAEs. The most commonly reported TRAEs were dysuria, fatigue, and hematuria.