Protara Therapeutics (Nasdaq: TARA) has announced promising interim results from its Phase 2 ADVANCED-2 trial evaluating TARA-002 in patients with non-muscle invasive bladder cancer (NMIBC), while simultaneously strengthening its financial position through a successful public offering.
Strong Clinical Efficacy in NMIBC Treatment
The Phase 2 open-label ADVANCED-2 trial has yielded impressive results, with TARA-002 demonstrating a 72% six-month landmark complete response rate across all BCG exposure levels. The drug showed particularly strong efficacy in BCG-Unresponsive patients, achieving a 100% six-month landmark complete response rate. BCG-Naïve patients also showed favorable outcomes with a 64% six-month landmark complete response rate.
The durability of response has been notably strong, with 100% of patients maintaining complete response from month six onwards. Additionally, the trial demonstrated an 80% reinduction salvage rate, suggesting robust therapeutic potential for patients who initially respond to treatment.
Strategic Financial Position
In a parallel development, Protara has successfully completed a $100 million public offering, pricing 13,690,000 shares of common stock at $6.25 per share and offering pre-funded warrants for an additional 2,325,372 shares. This financial infusion extends the company's operational runway into 2027, providing crucial support for ongoing clinical development programs.
Development Pipeline and Future Milestones
The company has outlined several key upcoming milestones for its TARA-002 program. Initial data from 12-month evaluable NMIBC patients in the ADVANCED-2 trial is expected in mid-2025, while results from a futility analysis of approximately 25 six-month evaluable BCG-Unresponsive patients are anticipated by the end of 2025.
Beyond NMIBC, Protara is advancing TARA-002 in other indications. The Phase 2 STARBORN-1 trial in pediatric patients with lymphatic malformations has completed its first cohort, with the treatment demonstrating compelling efficacy and favorable tolerability. Initial results from the next cohort are expected in the first half of 2025.
Expanding Treatment Portfolio
The company's development pipeline also includes IV Choline Chloride, which recently received Fast Track designation from the FDA. This designation was granted for patients receiving parenteral support, addressing a significant unmet need identified in the THRIVE-1 observational study, where 78% of patients dependent on parenteral support were found to be choline deficient.
