|The following article features coverage from the National Kidney Foundation’s virtual 2020 Spring Clinical Meetings. Click here to read more of Renal and Urology News’ conference coverage.|
Veverimer, a potential first-in-class acid binder now under FDA review, has a rapid onset of action, according to new research presented during the live virtual 2020 National Kidney Foundation Spring Clinical Meetings.
Four doses of veverimer were tested in a study of 135 patients (mean age 60 years; 64% male) with an estimated glomerular filtration rate (eGFR) of less than 60 but not lower than 20 mL/min/1.73 m2 and metabolic acidosis (serum bicarbonate 12 to 20 mEq/L). Veverimer 1.5 g, 3 g, and 4.5 g administered twice daily and veverimer 6 g once daily each significantly increased mean serum bicarbonate by 3 to 4 mEq/L over 2 weeks compared with placebo.
Serum bicarbonate increased significantly as early as 3 hours after the first dose in the veverimer 3 g and 4.5 g groups and within 48 hours in the 1.5 g and 6 g groups, David Bushinsky, MD, of the University of Rochester in Rochester, New York, and colleagues reported in a poster presentation.
“Veverimer acts quickly and has an excellent adverse effect profile,” Dr Bushinsky told Renal & Urology News. “The FDA recently accepted a new drug application for Veverimer. It is exciting to have the possibility of the first FDA-approved treatment for metabolic acidosis due to chronic kidney disease.”
With respect to safety, there were no serious or dose-related adverse events. The most common event was mild diarrhea. No patient discontinued treatment due to an adverse event, and no one experienced metabolic alkalosis (ie, serum bicarbonate higher than 29 mEq/L).
Veverimer is administered orally as a counterion-free, non-absorbed polymer that selectively binds hydrochloric acid in the gastrointestinal tract, which results in a rise in serum bicarbonate. In contrast to alkali supplements that neutralize acid, veverimer removes it.
In addition, veverimer produces no counterion load, unlike exchange resins that deliver excess sodium or potassium. In this study, veverimer recipients experienced no mean changes in electrolytes, such as serum sodium, potassium, chloride, magnesium, calcium, or phosphate.
Disclosure: Several study authors declared affiliations with Tricida, the developers of veverimer. Please see the original reference for a full list of authors’ disclosures.
Read more of our coverage of the National Kidney Foundation’s virtual 2020 Spring Clinical Meetings by visiting the conference page.
Bushinsky D, Mathur V, Biyani K, et al. Mechanism of action and onset of effect of veverimer, a novel acid binder for the treatment of metabolic acidosis associated with chronic kidney disease. Data presented at the live virtual 2020 National Kidney Foundation Spring Clinical Meetings held March 25 to 29. ePoster 314.