공고 • May 04
Mallinckrodt Presents Data Evaluating Acthar Gel for the Treatment of Severe Keratitis at the Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting Mallinckrodt plc announced data from its Phase 4, multi-center, open-label study to assess the efficacy and safety of Acthar Gel (repository corticotropin injection) in adult patients with treatment-resistant, severe non-infectious keratitis, a disease which involves painful inflammation of the cornea.1 The full results were presented in a poster at The Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting, and further data will be shared at the upcoming virtual International Society for Pharmacoeconomics and Outcomes Research (ISPOR) Annual Meeting. Acthar Gel is approved by the U.S. Food and Drug Administration (FDA) for the treatment of severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as: keratitis, iritis, iridocyclitis, diffuse posterior uveitis and choroiditis, optic neuritis, chorioretinitis, anterior segment inflammation. Please see Important Safety Information for Acthar Gel below. The primary efficacy endpoint of the study was the proportion of patients who improved by 12 points or more in the symptom bother module of the Impact of Dry Eye on Everyday Life (IDEEL) score at week 12. The IDEEL is a patient-reported outcome assessment with three modules "impact on daily life, treatment satisfaction and symptom bother "and six dimensions. After 12 weeks of treatment with Acthar Gel, 50.0% (n=17) of patients experienced improvements in their symptom bother score by at least 12 points, a clinically important change (95% CI 33.2, 66.8). 공고 • May 01
Mallinckrodt plc Presents Data Evaluating Inomax® (Nitric Oxide) Gas, for Inhalation in a Phase 4 Observational Registry in Neonates with Pulmonary Hypertension Mallinckrodt plc announced that data from its Phase 4 observational registry comparing the safety and effectiveness of INOmax® (nitric oxide) gas, for inhalation, in term and near-term (TNT) neonates to that in preterm (PT) neonates with pulmonary hypertension (PH) will be presented in a poster at The Pediatric Academic Societies (PAS) 2021 Virtual Meeting. The safety and efficacy of INOmax in premature neonates has not been evaluated by the U.S. Food and Drug Administration. INOmax has been on the market in the U.S. since 2000 and is indicated to improve oxygenation and reduce the need for extracorporeal membrane oxygenation in term and near-term (>34 weeks gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension in conjunction with ventilatory support and other appropriate agents. The primary outcome measure of the registry was the number of PT neonates and TNT neonates with a significant response to INOmax, which was defined as at least a 25% improvement (decrease) from baseline in oxygenation index or surrogate oxygenation index (OI/SOI) during INOmax treatment. 공고 • Mar 05
Mallinckrodt Announces New England Journal of Medicine Publication of Results from its Phase 3 CONFIRM Study of Terlipressin in Patients with Hepatorenal Syndrome Type 1 (HRS-1) Mallinckrodt plc announced publication of results from its pivotal Phase 3 CONFIRM study to assess the efficacy and safety of its investigational agent terlipressin in adults with hepatorenal syndrome type 1 (HRS-1). HRS-1 is an acute and life-threatening syndrome involving acute kidney failure in patients with cirrhosis,1 and has a median survival time of approximately two weeks and greater than 80% mortality within three months if left untreated. Terlipressin is an investigational product and its safety and effectiveness have not yet been established by the U.S. Food and Drug Administration (FDA) or Health Canada. As previously announced, the Phase 3 CONFIRM study met its primary endpoint of Verified HRS Reversal, which is defined as renal function improvement, avoidance of dialysis and short-term survival. The main objective of the CONFIRM study was to assess the efficacy and safety of terlipressin, together with albumin, versus placebo in adults in the U.S. and Canada with cirrhosis and HRS-1. The trial met three of the four pre-specified secondary endpoints of the study including HRS reversal, HRS reversal without renal replacement therapy (RRT) by Day 30 and HRS reversal in the systemic inflammatory response syndrome (SIRS) subgroup. In another pre-specified endpoint, avoidance of RRT, terlipressin treated subjects (n=199) showed a significantly lower incidence during the treatment period and a lower incidence at all follow-up assessments through Day 90 versus patients with placebo (n=101).4 This is clinically significant because RRT can increase complications in HRS-1 due to the underlying cirrhosis. The incidence of adverse events (AEs) of any severity were similar in both groups (88.0 percent of the terlipressin group and 88.9 percent of the placebo group). The most commonly reported AEs in the overall study population were abdominal pain, nausea, diarrhea, hepatic encephalopathy and dyspnea. Serious AEs (SAEs) were reported in 65.0 percent (n=130) of the terlipressin group and 60.6 percent (n=60) of the placebo group. The most commonly reported SAEs included hepatobiliary disorders, respiratory disorders and gastrointestinal disorders. 공고 • Feb 27
Silence Therapeutics plc & Mallinckrodt plc Initiate Work on 3Rd Target Silence Therapeutics plc announced the Company will receive a $2.0 million milestone payment following the initiation of work on a third target being explored under its ongoing RNAi research collaboration with Mallinckrodt plc for the treatment of complement pathway-mediated diseases. The collaboration is focused on the development and commercialization of RNAi therapeutics designed to inhibit or 'silence' the complement cascade, a group of proteins that are involved in the immune system and play a role in the development of inflammation. Using Silence's proprietary mRNAi GOLD (GalNAc Oligonucleotide Discovery) Platform, each target in the collaboration will be investigated before progressing into clinical development. 공고 • Feb 13
Mallinckrodt Provides Regulatory Update on StrataGraft® Mallinckrodt plc announced that the U.S. Food and Drug Administration (FDA) has informed the Company that it is deferring action (pending a site inspection) on the Stratatech Biologics License Application (BLA) for StrataGraft®, an investigational allogeneic cellularized scaffold product in development for the treatment of adult patients with deep partial-thickness burns. This is due to COVID-19-related travel restrictions, which are delaying a required manufacturing site inspection. The Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services (HHS), has provided funding and technical support for the continued development of StrataGraft under Project BioShield Contract. The FDA granted the BLA for StrataGraft priority review. Previously, the FDA granted StrataGraft orphan drug status, and it was among the first products designated by the agency as a Regenerative Medicine Advanced Therapy (RMAT) under the provisions of the 21st Century Cures Act. 
