Now that we've absorbed that exciting news release for the Phase 1 CKD trial, I thought it would be good to remind all of the imminent start to the Phase 2 CKD trial.
At the October 2016 R&D day presentation, Dr. Kamyar Kalantar-Zadeh described the proposed Phase 2b BETonDialysis trial with an estimated launch early 2017. The proposed design is a sequential cross-over trial to evaluate the safety, tolerability, and efficacy of apabetalone (200 mg daily) in high-risk CKD patients on hemodialysis. Up to 30 CKD subjects on hemodialysis, double-blinded, placebo-controlled, cross-over after 2 week washout. Proposed primary endpoint is ALP reduction. 2 week screening, 6 week duration, 2 week washout, 6 week treatment, 2 week follow up.
At the 12/15/16 Corporate Update, they indicated that this Phase 2 BETonDialysis trial will launch early 2017, will be in the US, and added that the washout period will be longer (~6 wks instead of the 2 wks shown on the slide). They also indicated in a slide from the Corporate Update and from Biotech Showcase in January 2017 presentation:
1) Filed for a Type B Meeting early fall 2016
2) Completed Type B Meeting late fall 2016, face to face in Washington
3) Received positive feedback on trial design and positive instructions to enhance the program without affecting the IND filing timeline
4) New Cardio/Renal IND on track for Q1 2017
So getting that IND filed, seeing something appear on ClinicalTrials.gov, and getting a NR on trial launch are the next steps here, IMO.
GLTA,
BearDownAZ
