- A novel VDR agonist (VDRA) that is highly efficacious with minimal side effects to achieve desirable efficacy and to allow usage in multiple indications (secondary hyperparathyroidism, disease progression and complications in Stage 3/4/5 chronic kidney disease, osteoporosis, psoriasis, inflammatory bowel disease, others).
- In pre-clinical CKD and osteoporosis animal models VS-105 not only suppresses parathyroid hormone, but also reduces proteinuria, improves cardiac/endothelial function, reduces heart and kidney fibrosis, and exhibits potent anabolic bone effects in a dose range that doesn’t affect serum calcium.wo US INDs filed successfully
- Two US INDs filed successfully: Secondary hyperparathyroidism associated with CKD; osteoporosis
- Phase I studies involving healthy subjects have been completed: No hypercalcemia and any other drug-related adverse events.
- A MAD study involving hemodialysis subjects is ongoing.
VS-505 and VS-605
- VS-505 is a novel phosphate binder derived from Fe (III) and gum Arabic in a complex that is highly efficacious with minimal side effects to achieve desirable efficacy for CKD patients to manage phosphate imbalance.
- VS-605 is a novel phosphate binder derived from Mg (II) and gum Arabic.
- Both act in the gastrointestinal tract without systemic exposure.
- Both have a high density (~1.9 g/mL) and a low swell-volume, which predicts a lower pill burden and greatly improved gastrointestinal safety profile. Pill burden and GI tolerability issues have been identified as significant factors contributing to low compliance for some prescribed phosphate binder therapy in CKD patients.
- Both are tasteless; there is no requirement for chewing to gain efficacy.
- Each Size 2 capsule contains 250 mg of the complex with 30% Fe (III) or Mg (II) and 70% gum Arabic.
- VS-505 has been evaluated in a proof-of concept clinical trial in hemodialysis patients. It is highly efficacious with minimal side effects; it also improves bowel movement and has no effect on plasma iron, transferrin, TSAT, and ferritin.