Company Overview of Shield Holdings AG
Shield Holdings AG, a specialty pharmaceutical company, focuses on the development and commercialization of late-stage mineral-derived hospital pharmaceuticals. It offers ST10, an oral ferric iron-based therapy for the treatment of iron deficiency; and PT20, an iron-based phosphate binder for the treatment of hyperphosphataemia related to dialysis-dependent or dialysis-independent chronic kidney disease. The company was founded in 2008 and is based in Wollerau, Switzerland.
Founded in 2008
Key Executives for Shield Holdings AG
Co-Founder and Chief Executive Officer
Co-Founder and Chief Medical Officer
Vice President of Regulatory Affairs
Director of Manufacturing
Compensation as of Fiscal Year 2014.
Shield Holdings AG Key Developments
Shield Therapeutics Announces Positive ST10 Data in Pivotal AEGIS Phase 3 Study
Jan 7 14
Shield Therapeutics announced strongly positive top-line data from the pivotal Phase 3 programme of ST10 for the treatment of iron deficiency anaemia (IDA) in inflammatory bowel disease (IBD). ST10 delivered a mean improvement in haemoglobin levels of 2.3g/dL (p <0.0001), clearly meeting the primary endpoint of haemoglobin change after 12 weeks' treatment compared to placebo. More than 65% of treated subjects experienced normalised haemoglobin levels by week 12 and ST10 also rapidly delivered significant improvements in haemoglobin at 4 weeks (1.1g/dL, p <0.0001) and 8 weeks (1.8g/dL, p <0.0001) of therapy. From a safety perspective, ST10 did not adversely affect IBD symptoms in treated subjects and was well tolerated for the duration of exposure. The two AEGIS protocols recruited 128 patients with anaemia secondary to either Crohn's disease or ulcerative colitis who had previously failed therapy with oral ferrous products due to intolerance and/or inadequate therapeutic benefit. Patients were recruited from expert centres in Austria, Germany, Hungary and the UK and were randomised (1:1) to receive ST10 or a matched placebo capsule. Other iron therapies were not permitted during the study. Adverse events recorded during the study were mainly gastrointestinal in nature and occurred in the ST10-treated arm with placebo-like frequency (38% of ST10-treated subjects and 40% of placebo-treated subjects). Withdrawal from the study before 12 weeks (due to adverse events or subject decision) occurred in seven ST10-treated and nine placebo-treated subjects. Patients who completed the 12-week double-blind phase of the study continued treatment in a 12-month open-label extension phase and results of this will be available later 2014. These results provide confirmatory pivotal clinical data which will form the basis of a Marketing Authorisation Application submission to the European regulatory authorities during 2014. In conjunction with data that will be generated from the study of ST10 in the treatment of IDA in pre-dialysis chronic kidney disease patients that is currently progressing, these results will also form part of a subsequent New Drug Application submission to the FDA in the USA.
US Food and Drug Administration Accepts New Drug (IND) Application of Shield Therapeutics to Initiate a Phase 3 Pivotal Study of ST10
Dec 16 13
Shield Therapeutics announced that the US Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application to initiate a Phase 3 pivotal study of ST10, its novel oral iron-replacement therapy, for the treatment of iron deficiency anaemia (IDA) in pre-dialysis patients with chronic kidney disease (CKD). The company plans to initiate the Phase 3 study in the US in H1 2014 and positive data would be the cornerstone of a subsequent NDA submission. AEGIS 3 will be a pivotal Phase 3, 16-week prospective, multicentre, randomized, double-blind, placebo controlled study and will enrol approximately 160 pre-dialysis CKD patients in the US who have been diagnosed with IDA. The primary endpoint of the study will be the change in haemoglobin from baseline to week 16. ST10 is a novel oral ferric iron therapy being developed for the treatment of IDA, which has demonstrated potential as an effective oral alternative to intravenous (IV) iron. As well as showing that gastrointestinal absorption of ST10 is at least as good as ferrous products in previous studies, ST10 has also been shown to have minimal gastro-intestinal side effects so can be given on an empty stomach at a much reduced daily dose and to patients who cannot take standard oral iron preparations, for whom the only alternative would be IV infusions of iron. As ST10 is not adversely affected by changes in gastric pH, it may also be effective when co-prescribed with widely used acid-reducers. ST10 is also currently being investigated in two pivotal Phase 3 studies as a treatment for IDA in inflammatory bowel disease, top-line results from which are expected in the coming months.
Shield Therapeutics Files Investigational New Drug Application for ST10 for the Treatment of Iron Deficiency in Chronic Kidney Disease
Nov 12 13
Shield Therapeutics announced that it has filed an investigational new drug (IND) application with the US Food and Drug Administration (FDA) to initiate a Phase 3 pivotal study of ST10, its novel oral iron-replacement therapy, for the treatment of iron deficiency anaemia (IDA) in pre-dialysis patients with chronic kidney disease (CKD). ST10 is a novel oral ferric iron therapy being developed for the treatment of iron deficiency which has demonstrated potential as an effective oral alternative to parenteral (IV) iron in ferrous intolerant patients. Previous clinical studies have shown that gastrointestinal absorption of ST10 is at least as good as ferrous products, however ST10 has minimal gastro-intestinal side effects so can be given on an empty stomach and is therefore given at a significantly lower daily dose. As ST10 is not adversely affected by changes in gastric pH, it can also be co-prescribed with widely used acid-reducers. The British National Formulary states: 'parenteral iron does not produce a faster response than oral iron provided the oral iron is taken reliably and is absorbed adequately.' ST10 aims to deliver this compelling alternative to prescribers, patients and payors, in addition to avoiding the inconvenience, high cost and life-threatening hypersensitivity risks associated with IV infusions. The 16-week prospective, multicentre, randomized, double-blind, placebo controlled AEGIS 3 study will enrol pre-dialysis CKD patients in the USA who have a diagnosis with iron deficiency anaemia. ST10 is also currently being investigated in a pivotal Phase 3 study as a potential treatment for IDA in inflammatory bowel disease, top-line results from which are expected towards the end of 2013.
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