A novel vitamin D analog effectively suppresses iPTH in hemodialysis patients

2MD (DP001), a novel, oral vitamin D analog, was able to effectively reduce intact PTH (iPTH) levels in hemodialysis patients with secondary hyperparathyroidism previously treated with a vitamin D analog, with or without a calcimimetic. The results of this phase 2B safety and efficacy study appear in the latest issue of the American Journal of Nephrology.

 

62 hemodialysis patients with iPTH ≥ 300 pg/ml were randomized to either DP001 or placebo and followed for 12 weeks. Primary endpoint was 2 consecutive reductions in iPTH of ≥ 30%.  Calcium, phosphorus, and calcium-phosphorus product were also evaluated. At the end of the study period, patients who reached the primary endpoint were 78% for the DP001 group and 7% for the placebo group (p < 0.0001). Overall, iPTH values decreased 45% in the DP001 group and increased 37% in the placebo group. In terms of safety, there were no patients in the DP001 group that showed calcium levels ≥11.0 mg/dl on 2 consecutive measurements of corrected calcium. There were no appreciable differences in phosphorus levels between the groups.

 

Secondary hyperparathyroidism is a common condition in patients with chronic kidney disease both on dialysis and not on dialysis. Current vitamin D analogs have frequent side effects of elevated calcium and phosphorus levels, which have been associated with increased morbidity and mortality. DP001 was developed to be more potent and more selective in its targets, with the goal of decreasing iPTH while minimizing elevations in calcium and phosphorus.  DP001 is licensed by Deltanoid Pharmaceuticals.

 

– Biocoast Capital is an advisory and investment firm for the finance and life science industries.  We invest in novel drugs, medical devices and diagnostics that have the potential to revolutionize the healthcare industry.  We provide consulting services to some of the most exciting healthcare and finance companies in the world.  Biocoast Capital and the author has no relevant financial or nonfinancial relationships to Deltanoid Pharmaceuticals.