Last Thursday, La Jolla Pharmaceuticals issued a press release stating that the results of the Interim Analysis of the LJ401-HH01 (HERCULES) study confirmed the study had met its primary endpoint. The change in Transferrin Saturation (TSAT) from baseline to the end of treatment (16 weeks), was statistically significant: LJPC-401-treated patients had a mean reduction in TSAT of 42% compared to placebo-treated patients who had a mean reduction of 6% (p<0.0001).
The interim analysis confirmed a statistically significant reduction in the number of venesections (therapeutic phlebotomy) required between the treatment and placebo group (p=0.003).
The results of the full results of the trial are expected in the second half of 2019.
Affinity Murdoch would like to thank our patients who generously gave their time to be involved in this study.
About the LJ401-HH01 (HERCULES) Trial
The LJ401-HH01 (HERCULES) trial was a Phase 2, Multi-center, Randomized, Placebo-controlled, Single-blind Study with LJPC-401 for the Treatment of Iron Overload in Adult Patients with Hereditary Hemochromatosis. The trial enrolled 76 patients at 30 different sites around the world. Patients were randomised to receive weekly subcutaneous injections of either LJPC-401 or placebo for 16 weeks.
LJPC-401 is a synthetic human hepcidin. Synthetic human hepcidin is a chemically made version of the naturally occurring human hepcidin that helps to regulate (control) how iron is distributed in the body.
About Hereditary Haemochromatosis
Hereditary Haemochromatosis (HH), also called iron overload, is a genetic disorder that causes the body to absorb too much iron from the diet. The excess iron is stored in the body’s tissues and organs (such as the liver, heart, skin, joints and pancreas) which, if left untreated, eventually leads to tissue and organ damage. HH is the most common genetic condition in Australia, affecting 1 in 200 people of northern European origin.
To find out more about HH, visit the Haemochromatosis Australia website.
About Affinity Murdoch
Affinity Murdoch is a dedicated clinical trial unit located in the Perth suburb of Murdoch, Western Australia. Affinity Murdoch was established in 2017 to meet the changing needs of clinical research in Australia. To find out more, contact one of our dedicated site staff.
Affinity wishes to thank Professor John Olynyk for heading this trial in Western Australia and Clinical Research Nurse Tracie Ernenwein for her dedication in making the trial a success.
The full press release can be viewed on La Jolla Pharmaceutical website.