FDA Clears Regulus Therapeutics' IND for RGLS8429 In Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Regulus Therapeutics Inc. RGLS announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) Application for RGLS8429 for the treatment of Autosomal Dominant Polycystic Kidney Disease (ADPKD).

The company plans to initiate phase 1 single-ascending dose (SAD) clinical study in the second quarter,  investigating RGLS8429 in healthy volunteers.

Further, the Phase 1b multiple ascending dose (MAD) study will be initiated in adult patients with ADPKD to evaluate the efficacy of RGLS8429 treatment across three different dose levels including changes in polycystins, cystic kidney volume (htTKV), and overall kidney function.

Jay Hagan, President and Chief Executive Officer, commented, ”With FDA's acceptance of our IND and the Phase 1 trial preparations well underway, we look forward to advancing this program which ultimately may provide a transformative treatment option for patients with ADPKD”.

The enrolment of patients with ADPKD is anticipated in the second half of this year.

Regulus Therapeutics shares are trading high 15 percent at $0.20 in the pre-market session.