Protara Therapeutics, Inc.
For the period ended Mar 5, 2025. Filed Mar 5, 2025.
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Mar 5, 2025 · Filed Mar 5, 2025
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TARA$2.30+8.0%Stored close · as of Nov 6, 2026
Contents
EX-99.1 · Recent Progress and Highlights
Recent Progress and Highlights
| ● | The Company is on track to report 12-month data by mid-year from its ongoing Phase 2 open-label ADVANCED-2 trial in evaluable NMIBC patients with carcinoma in situ or CIS (± Ta/T1) who are Bacillus Calmette-Guérin (BCG)-Unresponsive and BCG-Naïve. In December 2024, the Company reported positive interim results in which the complete response (CR) rate across BCG exposures was 72% (13/18) at six months and 70% (14/20) at any time, with 100% (9/9) of patients maintaining a CR from three months to six months. In addition, two of three patients maintained a CR at nine months. TARA-002 showed a favorable safety profile, with no Grade 2 or greater treatment-related adverse events and no treatment discontinuations due to adverse events. |
| ● | Interim results from approximately 25 six-month evaluable BCG-Unresponsive patients are expected to be announced by the end of 2025. As previously communicated, the BCG-Unresponsive cohort is designed to be registrational in alignment with the 2024 BCG-Unresponsive Non-muscle Invasive Bladder Cancer: Developing Drugs and Biological Products for Treatment Draft Guidance for Industry issued by the U.S. Food and Drug Administration (FDA). |
| ● | Following regulatory alignment with the FDA, the Company expects to provide an update on the design of its planned BCG-Naïve registrational trial by the end of the first half of 2025. |
| ● | Protara continues to investigate systemic subcutaneous dosing through priming and maintenance combined with intravesical dosing, as well as exploring combination treatment with TARA-002 in NMIBC patients with CIS. Given what has been observed to date with TARA-002’s mechanism of action and strong safety profile, the Company believes it holds significant potential for use in both systemic dosing and combination therapy and is finalizing various opportunities. |
IV Choline Chloride for Patients on Parenteral Support (PS)
| ● | The Company plans to initiate THRIVE-3, a registrational Phase 3 clinical trial, in the first half of 2025. THRIVE-3 is a seamless Phase 2b/3 trial with a dose confirmation portion (n=24) followed by a double-blinded, randomized, placebo-controlled portion to assess the efficacy and safety of IV Choline Chloride over 24 weeks in adolescents and adults on long-term PS when oral or enteral nutrition is not possible, insufficient, or contraindicated (n=100). IV Choline Chloride was previously granted Fast Track designation by the FDA. |
TARA-002 in LMs
| ● | Protara remains on track to provide an interim update on the Phase 2 STARBORN-1 trial of TARA-002 in pediatric patients with macrocystic and mixed cystic LMs by the end of the first half of 2025. The Company previously announced the completion of the study’s first safety cohort, in which TARA-002 showed promising results and was generally well-tolerated. |
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