FibroGen's Pamrevlumab Doesn't Meet Goals In Phase III LELANTOS-2 Trial; Stock Down In Pre-market

(RTTNews) - FibroGen, Inc. (FGEN), a biopharmaceutical company, on Wednesday said that the study from its phase III trial evaluating pamrevlumab for the treatment of ambulatory patients with Duchenne muscular dystrophy (DMD), dubbed LELANTOS-2 failed.

The news drove the stock down by 22 percent in pre-market.

The primary endpoint of the study was ambulatory function measured by change in the North Star Ambulatory Assessment (NSAA) total score from baseline to Week 52.

Secondary endpoints assessed changes from baseline to Week 52 in 4-stair climb velocity, 10-meter walk/run test, time to stand, time to loss of ambulation, and proportion of patients with greater than 10 seconds in the 10-meter walk/run test.

The study did not meet the primary endpoint of change in the North Star Ambulatory Assessment (NSAA) total score as well as the secondary endpoints.

Serious adverse events were observed in 8.3 percent of the patients in the pamrevlumab group compared to 2.8 percent in in the placebo group. Though prelimnary safety data showed that the drug was safe and well tolerated.

The LELANTOS-2 is a phase III trial where a total of 73 boys between the ages 6 to less than 12 with ambulatory DMD were dosed with pamrevlumab 35 mg/kg IV on Day 1 and every two weeks thereafter with last dose at Week 52 or placebo.

As per the company, DMD is a rare neuromuscular disease that affects around 1 in every 5,000 newborn boys. It is a fatal disease caused by genetic mutation leading to the absence or defect of dystrophin, a protein necessary for normal muscle function.

The absence of this protein could lead to muscle weakness, muscle loss, fibrosis, and inflammation.

In pre-market activity, shares of FibroGen are trading at $0.99 down 22.25% on Nasdaq.