La Jolla Experimental Kidney Drug Phase 2 Trial Meets Primary Goal, Stock Surges

(RTTNews) - La Jolla Pharmaceutical Co (LJPC) Monday said its randomized, placebo-controlled Phase 2 trial of GCS-100 in chronic kidney disease or CKD met its primary efficacy endpoint of a statistically significant improvement in kidney function. The stock, which ended the regular trade up by around 12 percent, surged over 62 percent in after-hours trading.

In the trial, a dose of 1.5 mg/m2 led to a statistically significant increase in estimated glomerular filtration rate or eGFR) compared to placebo between baseline and end of treatment. At the 30 mg/m2 dose, there was no statistically significant difference.

Key secondary endpoints were also met, and the effect on circulating galectin-3 levels was consistent with the effect on eGFR.

For the 1.5 mg/m2 dose, there was a statistically significant (p=0.067) reduction in circulating levels of galectin-3. There was no significant difference at the 30 mg/m2 dose level.

Galectin-3 is the molecular target of GCS-100 and has been shown to be a mediator of tissue fibrosis. Potassium, uric acid and blood urea nitrogen all improved at the 1.5 mg/m2 dose level.

The trial showed that GCS-100 was well-tolerated. Out of 121 patients enrolled, 117 completed treatment, including all 41 patients treated at the 1.5 mg/m2 dose.

There were no serious adverse events in the 1.5 mg/m2 dose group compared to two in the placebo group and two in the 30 mg/m2 group. All adverse evets were deemed by the investigators as not drug-related.

The stock, which closed up about 12 percent on Monday at $10.90, surged 62.4 percent in the extended trade.