Enrollment starts in Ph III trial of NPS' hypoparathyroidism drug

The USA's NPS Pharmaceuticals has begun patient enrollment in a Phase III registration study, known as REPLACE, evaluating NPSP558 for the  treatment of adults with hypoparathyroidism.

The agent is the company's proprietary recombinant full-length human  parathyroid hormone (PTH 1-84), which mimics the action of natural  parathyroid hormone. Hypoparathyroidism is a rare condition in which  the body produces insufficient levels of parathyroid hormone causing  lower than normal levels of calcium in the blood, known as hypocalcemia.  There is currently no approved replacement therapy for  hypoparathyroidism. NPS believes positive results from REPLACE will  enable it to seek USA marketing approval for NPSP558 for the treatment  of the condition.

Francois Nader, chief executive of NPS, said: "we are encouraged by  NPSP558's activity to date and believe it has the optimal  mechanism-of-action to address the significant needs of this underserved  patient population. We expect to complete the study and report top-line  results in the second half of 2010."