Protara Therapeutics (TARA), a clinical-stage company, on Thursday, announced positive results from its ongoing Phase 2 ADVANCED-2 trial.
ADVANCED-2 is an ongoing phase II trial of the company's drug candidate TARA-002 in patients with non-muscle invasive bladder cancer (NMIBC), including those who are BCG-Unresponsive or BCG-Naïve.
According to the trial findings, TARA-002 demonstrated a 72 percent six-month complete response (CR) rate across BCG exposures, with 70 percent CR at any time.
In BCG-Unresponsive patients, the CR rate was 100 percent at six months, and 64 percent in BCG-Naïve patients.
TARA-002 also demonstrated durability, with all patients maintaining CR from three to six months. It had a favorable safety profile with no Grade 2 or greater adverse events, and no patients discontinued due to adverse events.
The company is also evaluating TARA-002 in a phase II trial in lymphatic malformations, dubbed STARBORN-1. Lymphatic malformations refer to a rare condition primarily impacting children for which there are no FDA approved therapies.
Interim data from the STARBORN-1 trial is expected in the first half of 2025
In September 2024, the U.S. Food and Drug Administration (FDA) granted TARA-002 Rare Pediatric Disease designation for the treatment of Lymphatic Malformations (LMs), underscoring its potential as a therapeutic option for this rare condition.
TARA closed Wednesday's trading at $3.54, up 25.53%. In premarket trading, the stock is up by 33.05% at $4.72.
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