공시 • Apr 28
MEDLEAP Pharma Confirms Enrollment in Phase II Clinical Trial for Accrufer in Japan Shield Therapeutics plc announced that its partner, MEDLEAP Pharma, a subsidiary of Vital KSK Holdings Inc. has confirmed its first patient enrollment for the Phase II clinical trial for ACCRUFeR (ferric maltol), a new drug candidate for Pulmonary Arterial Hypertension (PAH), for patients in Japan. This clinical trial is an exploratory study intended to support a planned Phase III trial. It follows the Pharmaceuticals and Medical Devices Agency's (PMDA) confirmation of the development plan for the drug as a PAH treatment in Japan, based on the drug's prior clinical results from trials in Europe, the UK, and the USA. Trial Details: Trial Name: An Exploratory Phase II Study to Evaluate the Efficacy and Safety of Ferric Maltol in Patients with Pulmonary Arterial Hypertension. Target Disease: Pulmonary Arterial Hypertension. Trial Location: Japan. ACCRUFeR/FeRACCRU (ferric maltol) is a novel, stable, non-salt-based oral therapy for patients suffering from iron deficiency, with or without anemia. The drug has a novel mechanism of absorption compared to other oral iron therapies and has been shown to be an efficacious and well-tolerated therapy in a range of clinical trials. More information about ACCRUFeR/FeRACCRU, including the product label, can be found at: www.accrufer.com and www.feraccru.com. PAH (Pulmonary Arterial Hypertension) market in 2024 is estimated to be worth over $230M in Japan. Iron supplementation is strongly recommended for PAH patients with iron deficiency anemia according to both European and Japanese guidance (ESC/ERS Guidelines for the diagnosis and treatment of pulmonary hypertension 2022 and Japan Pulmonary Hypertension and Pulmonary Circulation Society Guidance 2024) [Recommendation Class I]. (1) Humbert M, et al. 2022 ESC/ERS Guidelines for the diagnosis and treatment of pulmonary hypertension. Eur Respir J. 2023; 61(1):2200879. (2) Japanese Pulmonary Hypertension and Pulmonary Circulation Society. Pulmonary Hypertension Treatment Guidance 2024. 공시 • Apr 11
Shield Therapeutics plc, Annual General Meeting, Jun 18, 2026 Shield Therapeutics plc, Annual General Meeting, Jun 18, 2026. Location: the offices of shield therapeutics plc, northern design centre, baltic business quarter, gateshead quays, england, ne8 3df, United Kingdom 공시 • Apr 02
Shield Therapeutics plc Announces European Medicines Agency Approves Extension of Indication for FeRACCRU to Include Adolescents Shield Therapeutics plc announced that the European Medicines Agency (EMA) have published the CHMP meeting highlights in which they confirm their adoption of a positive opinion for the extension of the indication for FeRACCRU (ferric maltol) to include adolescents. FeRACCRU will now be indicated for the treatment of iron deficiency in adult and pediatric patients 12 years of age and older. EMA have also confirmed that all measures in the agreed Pediatric Investigation Plan (PIP) for FeRACCRU have been fulfilled. The indication expansion was supported by positive results from the Phase 3 pediatric clinical trial (FORTIS/ST10-01-305) that confirmed the efficacy, safety, and tolerability of the new oral liquid pediatric formulation in children aged 1 month and above with iron deficiency, presenting as iron deficiency anemia (IDA). Shield's licensing partner, Norgine B.V. holds the marketing authorisation and is responsible for commercialising FeRACCRU in the European Union. Shield will receive a milestone payment of EUR 500,000 from Norgine related to this EMA approval for the term of the agreement. Clinically low iron levels (aka iron deficiency, ID) can cause serious health problems for adults of all ages, across multiple therapeutic areas. Together, ID and ID with anemia (IDA) affect about 20 million people in the US and represent a $2.3B market opportunity. As the first and only FDA approved oral iron to treat ID/IDA, ACCRUFeR has the potential to meet an important unmet medical need for both physicians and patients and is now the #1 branded prescription oral iron the market today (*data source - IQVIA Xponent PlanTrak). ACCRUFeR/FeRACCRU (ferric maltol) is a novel, stable, non-salt-based oral therapy for adults with ID/IDA. The drug has a novel mechanism of absorption compared to other oral iron therapies and has been shown to be an efficacious and well-tolerated therapy in a range of clinical trials. More information about ACCRUFeR/FeRACCRU, including the product label, can be found at: www.accrufer.com and www.feraccru.com. The open label randomized Phase 3 study included children aged 1 month to 17 years with mild to moderate IDA, who also had serum ferritin levels below 30 µg/L or ferritin levels below 50 µg/L and transferrin saturation below 20%. Children aged 2 to 17 years were randomized 1:1 to receive either ferric maltol (N=31) or ferrous sulphate (N = 30). Children 1 month to under 2 years (N=4) were all assigned to receive ferric maltol treatment. The full data sets have been submitted for peer-review and subsequent presentation/publication. The trial is the final study in the comprehensive pediatric development program that Shield committed to implement with both the European EMA and the US FDA. 공시 • Mar 05
Shield Therapeutics Plc Announces Chinese NMPA Accepts MAA Submission For ACCRUFeR Shield Therapeutics plc announced the filing, and acceptance by the Chinese National Medical Products Administration ('NMPA'), of a Marketing Authorisation Application ('MAA') for ACCRUFeR for the treatment of adults with Iron Deficiency by its licensing partner, Beijing Aosaikang Pharmaceutical Co. Ltd. ('ASK Pharm'). The MAA is supported by the data Package used to obtain USA FDA approval for ACCRUFeR for the treatment of iron deficiency in adults, supplemented by Phase 3 data confirming the effectiveness of ACCRUFeR in an adult Chinese population. This follows the successful completion and outcome of a Phase 3 efficacy and safety clinical study in Chinese adults with iron deficiency anemia ('IDA') and inflammatory bowel disease who are intolerant to oral ferrous products. The study demonstrated clinically and statistically relevant efficacy and good tolerance in Chinese adults. ACCRUFeR/FeRACCRU (ferric maltol) is a novel, stable, non-salt-based oral therapy for adults with ID/IDA. The drug has a novel mechanism of absorption compared to other oral iron therapies and has been shown to be an efficacious and well-tolerated therapy in a range of clinical trials. China's iron deficiency anemia (IDA) therapy market is growing rapidly, projected to double from around $280 million in 2022 to over $600 million by 2030. This growth is driven by increased healthcare access, government initiatives, and rising awareness. High-risk groups include women of reproductive age, pregnant women, and children-particularly in central-south and western regions. ACCRUFeR/FeRACCRU has patent coverage until the mid-2030s. ACCRUFeR/FeRACCRU are registered trademarks of Shield Therapeutics. The double-blind placebo-controlled randomized Phase 3 study included adults with mild to moderate iron-deficiency anemia (IDA) and Inflammatory Bowel Disease (IBD) who are intolerant to oral ferrous product, and who also had serum ferritin levels below 100 µg/L and transferrin saturation below 20%. Subjects were randomized 1:1 to receive either ferric maltol (N=60) or placebo (N = 61) bid for 12 weeks. 공시 • Feb 18
Shield Therapeutics plc Announces U.S. Food and Drug Administration Approval of ACCRUFeR Shield Therapeutics plc announced that ACCRUFeR (ferric maltol) is the first and only prescription oral iron treatment approved by the U.S. Food and Drug Administration for the treatment of iron deficiency in children age 10 and older. ACCRUFeR has been FDA-approved and prescribed for adults with iron deficiency since 2019. Iron deficiency affects about 2.4 million children in the United States, with adolescents at a particularly high risk. Up to 40% of females age 12-21 may be affected due to periodation and increased iron needs during period. Other common risk factors include not eating enough iron-rich foods, high-intensity athletic training, obesity, and growth spurts. Early treatment of iron deficiency in children is critical. Un unnoticed or untreated iron deficiency can lead to developmental delays, difficulty with learning and concentration, decreased academic performance, behavioral issues, and a weakened immune system. Common signs of low iron in children include unusual fatigue, paleness, irritability, or difficulty keeping up in school or activities. If parents have concerns surrounding iron deficiency they should speak with their child's doctor who may recommend performing blood tests to diagnose iron deficiency or iron deficiency anemia. Many families have experienced challenges with traditional iron supplements, which can cause stomach upset, nausea, or constipation - side effects that make it difficult for children to stick with treatment. ACCRUFeR®? was designed with tolerability in mind. For children ages 10 and up, ACCRUFeRACCRU®? is a new option that can help restore iron levels while minimizing the risk of GI side effects. 공시 • Feb 11
Shield Therapeutics plc Announces FDA Grants Additional 3 Years Exclusivity for ACCRUFeR Shield Therapeutics plc announced that the US Food and Drug Administration (FDA) has granted to Shield an additional 3 years of Data Exclusivity for ACCRUFeR (ferric maltol). This is due to the new clinical investigation conducted by Shield that was essential to the approval of the extension of the indication to include pediatric patients 10 years of age and older. This exclusivity remains in place until 19 December 2028 in addition to the ACCRUFeR)/FeRACCRU patent coverage valid until the mid-2030s. The indication expansion was supported by positive results from the Phase 3 pediatric clinical trial (FORTIS/ST10-01-305) that confirmed the efficacy, safety, and tolerability of the new oral liquid pediatric formulation in children aged 1 month and above with iron deficiency, presenting as iron deficiency anemia (IDA). 
