Amgen’s AMG 416 trial for SHPT treatment meets primary and secondary endpoints

19th August 2014 (Last Updated August 19th, 2014 18:30)

US-based biopharmaceutical firm Amgen has reported positive results from its second placebo-controlled phase three trial of AMG 416 to treat secondary hyperparathyroidism (SHPT) in patients with chronic kidney disease (CKD).

US-based biopharmaceutical firm Amgen has reported positive results from its second placebo-controlled phase three trial of AMG 416 to treat secondary hyperparathyroidism (SHPT) in patients with chronic kidney disease (CKD).

The company said that the 26-week, randomised, double-blind, placebo-controlled trial met all primary and secondary endpoints.

The trial evaluated the efficacy and safety of AMG 416 to treat SHPT in 508 patients with CKD receiving haemodialysis.

In the trial, patients were given AMG 416 or a placebo three times a week by intravenous injection with each haemodialysis treatment, while doses ranged from a minimum of 2.5mg to a maximum of 15mg.

"AMG 416 could become an important new treatment option for dialysis patients with secondary hyperparathyroidism."

Patients were also given a standard of care which could include calcium supplements, vitamin D sterols and phosphate binders, if prescribed by the individual physician.

The trial's primary endpoint was the proportion of patients with greather than 30% reduction from the baseline in parathyroid hormone (PTH) levels during an efficacy assessment phase (EAP), defined as the period between weeks 20 and 27.

In the AMG 416 group, 74% of patients achieved a greater than 30% reduction from baseline in PTH, compared with 8.3% in the placebo arm, marking a statistically significant result.

Secondary endpoints of the trial included the percent change from baseline during the EAP in serum phosphorus (P) concentration and corrected calcium (cCa) concentration.

The company said that both secondary endpoint results were statistically significant.

Amgen executive vice-president of research and development Sean Harper said: "The results from this second phase three study help to confirm that AMG 416 could become an important new treatment option for dialysis patients with secondary hyperparathyroidism.

"Despite the variety of options available for the treatment of this disease, an unmet need remains for an intravenous therapy that can be administered along with haemodialysis.

"We look forward to sharing results of a head-to-head study evaluating AMG 416 compared to cinacalcet next year."

The results follow the recent announcement of positive data from a prior placebo-controlled phase three trial of AMG 416, which was similar in design and size.