Shots:

• The first patient has been dosed in the P-III (ACTION) study to evaluate lixivaptan vs PBO in 1350 patients with ADPKD at 200+ sites in ~20 countries. The patient enrollment is expected to be complete in H2’23
• The 1EPs is to assess lixivaptan in slowing the decline in renal function as measured by the difference in eGFR @ 52wks., patients who completed Part 1 are expected to enter into Part 2 & will be treated for an additional year to evaluate the sustainability of the benefit on eGFR change @2yr.
• Additionally, IDMC will review safety data including the liver chemistry data. The company also plans to submit an NDA after completion of the 1yr. double-blind portion of the study

 Ref: Globe Newswire | Image: Businesswire