REGENXBIO Reports Positive Results From Phase I/II AFFINITY DUCHENNE Trial

(RTTNews) - REGENXBIO Inc. (RGNX) Wednesday reported additional positive results from the Phase I/II AFFINITY DUCHENNE trial of RGX-202 in patients with Duchenne muscular dystrophy.

The Phase I/II AFFINITY DUCHENNE trial is designed to evaluate the safety, tolerability and clinical efficacy of a one-time intravenous (IV) dose of RGX-202 in patients with Duchenne.

As per new data, a patient aged 6.6 years old, who received RGX-202 at dose level 1, had microdystrophin expression level at 83.4% of control at three months. A reduction from baseline in serum creatinine kinase (CK) levels of 93% was observed at ten weeks.

The company said it is on track to initiate pivotal trial in second half of 2024.

REGENXBIO shares are up more than 14% in pre-market. The stock had closed at $13.05, up 5.93% on Tuesday. It has traded in the range of $11.83 - $25.32 in the last 1 year.