Emerging Indications

Our specialized expertise in bone and bone marrow diseases and the ability to leverage existing safety data, as well as the clear demonstration of bone formation activity and dose finding in Phase 2, should enable us to move ZT-031 quickly into additional indications in which stimulation of bone formation has therapeutic utility. 

Renal Bone Disease (RBD)
Bone disease is common in patients with end stage renal disease (CKD 5) and increasingly recognized as a problem in the management of less severe renal impairment (CKD 3 and 4).  One of the forms of RBD is adynamic bone disease in which all bone surfaces become inactive and no active bone formation occurs.  RBD may be present in up to 50% of cases as a consequence of the renal disease and the effects of treatment by agents such as cinacalcet Sensipar® (cinacalcet) and Zemplar®  (paracalcitol). 

Adynamic bone disease is a significant problem for several reasons:

• It leads to decreased bone mass and increased risk of fracture and can exacerbate the severity of osteoporosis after kidney transplant
• The inability of the adynamic bone to act as a reservoir for excess circulating calcium and phosphate leads to a greater propensity for soft tissue calcification, which has been implicated as an important etiological factor in the increased risk of cardiovascular disease in renal disease

Zelos is exploring the use of PTH analogs with increased anabolic potential to ameliorate adynamic bone disease.  Based on the clinical profile for  ZT-031, we believe that it may be possible to provide sufficient bone formation stimulus without leading to increases in serum calcium that might be caused by concurrent stimulation of bone resorption.  Initially we are working with a university research group which is performing a proof of concept study exploring the safety and efficacy of ZT-031 in patients with adynamic renal bone disease.  Zelos is providing ZT-031 as well as a research grant for the study.

Sensipar® is a registered trademark of Amgen Inc.
Zemplar® is a registered trademark of Abbott Laboratories.