Mallinckrodt starts enrolment in Phase lV trial of acthar gel to treat FSGS

17th May 2016 (Last Updated May 17th, 2016 18:30)

Global specialty biopharmaceutical company Mallinckrodt has enrolled patients for its Phase lV clinical trial, PODOCYTE, of acthar gel (repository corticotropin injection) for inducing remission of proteinuria due to treatment-resistant or treatment-intolerant, idiopathic, focal segmental glomerulosclerosis (FSGS).

Global specialty biopharmaceutical company Mallinckrodt has enrolled patients for its Phase lV clinical trial, PODOCYTE, of acthar gel (repository corticotropin injection) for inducing remission of proteinuria due to treatment-resistant or treatment-intolerant, idiopathic, focal segmental glomerulosclerosis (FSGS).

FSGS is a rare disease that can cause nephrotic syndrome (NS), a serious kidney disorder.

The Treatment of Proteinuria Due to Treatment-Resistant or Treatment-Intolerant Idiopathic Focal Segmental Glomerulosclerosis: A 2 Part Prospective Study of H.P. Acthar Gel (PODOCYTE) trial is a Phase lV, multicentre, randomised, double-blind, parallel group, placebo-controlled efficacy trial.

The trial's primary endpoint is to measure complete and partial remission of proteinuria at week 24 compared with patients' baseline.

"The trial's primary endpoint is to measure complete and partial remission of proteinuria at week 24 compared with patients' baseline."

It is expected to take a number of years to complete.

Mallinckrodt noted that acthar gel is an injectable drug approved by the US Food and Drug Administration (FDA) to treat 19 indications.

Out of these 19 indications, currently promoted on-label indications include inducing a diuresis or a remission of proteinuria in nephrotic syndrome without uremia of the idiopathic type, or that which is due to lupus erythematosus.

The injectable drug can be used for the treatment of acute exacerbations of multiple sclerosis in adults, as monotherapy to treat infantile spasms in infants and children under two years of age, during an exacerbation or as maintenance therapy in selected cases of systemic lupus erythematosus.

Acthar can also be used during an exacerbation or as maintenance therapy in selected cases of systemic dermatomyositis (polymyositis).

Mallinckrodt chief scientific officer and senior vice-president Dr Steven Romano said: "Mallinckrodt is committed to providing treatment options where few exist.

"Clinical experience supports the use of Acthar to induce remission of proteinuria in FSGS.

"We are pleased to enroll the first patient in the PODOCYTE trial to better understand how clinicians may utilise Acthar within the management of proteinuria in this patient population."