Myositis, Inclusion Body

STOCKHOLM, March 13, 2024 /PRNewswire/ -- Today, a study on Improved physical function using a power-enhancing glove in persons with Inclusion Body Myositis was presented at the Global Conference on Myositis in Pittsburgh, USA. The preliminary results show increased hand function and improved physical function for people with impaired hand function during use of Carbonhand. Inclusion body myositis (IBM) is an autoimmune disease that primarily affects skeletal muscles with reduced muscle strength and endurance as characteristic symptoms. People with IBM experience challenges in many areas of their lives. Gripping and holding objects as well as fine-motor activities are major parts of the challenges they face. Individuals with advanced IBM have difficulties holding utensils, gripping a glass to drink, holding a toothbrush, dressing, and undressing as well as many other activities of daily living requiring grip. The study aimed to investigate if a power-enhancing glove is feasible to use in persons with IBM. Data was collected during The Myositis Association's (TMA) patient conference in September 2023. The study was open to people with idiopathic inflammatory myopathies who perceived hand weakness. The analysis carried out is based on people with IBM. To assess the degree of impairment, Physical function (IBM-Patient Reported Outcome Upper Extremity Function Scale (IBM-PRO), IBM-Functional Rating Scale (IBM-FRS)), pain (numeric rating scale), and grip strength (Jamar) were measured. The study included 40 persons with IBM that had reduced grip strength (kg) (md;range) (3.75;1.3-10.7) and physical function (IBM-FRS 20;2-38, IBM-PRO 23;1-44). The participants selected three activities that they perceived as difficult. The participants performed the activities and rated their ability to perform the chosen activities on a 5-point scale (0 = "unable to do", 4= "without any difficulty"), first without the glove and then upon using the glove. After testing the glove, the participants answered a series of open-ended questions regarding their perception of the glove. The result All activities were perceived as easier to perform with the glove. The conclusion is that people with IBM can perform activities in daily living more independently when using Carbonhand as an assistive device. The three most selected activities, with pre-and post-glove ratings, are shown in Table 1. In the open-ended questions, participants documented that the glove would be beneficial for use in everyday tasks, lifting objects, grocery shopping, stabilizing the hand, and would increase independence. Table 1. Measures on difficulty in chosen activities without and with the glove (0="unable to do", 4="without any difficulty"). About the study The study is initiated by Karolinska University Hospital, Stockholm, Sweden, in collaboration with Louisiana State University and Tulane University Schools of Medicine, New Orleans, United States, Washington University School of Medicine, St. Louis, United States, The Ohio State University College of Medicine, Department of Pediatrics, Columbus, United States, Deutsche Gesellschaft für Muskelkranke e.V.", DGM, Taunusstein, Germany, Spierziekten Nederland (Dutch patient association for NMD), Rotterdam, The Netherlands, The Swedish Rheumatism Association, Stockholm, Sweden, and Bioservo AB, Stockholm, Sweden. About Carbonhand Carbonhand is a medical device in the form of a grip-enhancing glove that enables people with impaired hand function, like IBM, to regain the ability to use their hands. Sensors in the glove send signals to a sophisticated control system that activates motors that pull on artificial tendons sewn into the glove, creating a natural and dynamic grip. Several studies with more than 300 participants show that people with impaired hand function get a sustained and strong grip with Carbonhand, improving the user's ability to perform activities of daily living. For more information, please contact Annika Rydgård, Head of Clinical Projects and Market Access at Bioservo AB Phone: +46 70 440 41 71 Email: [email protected] Mikael Wester, Marketing Director at Bioservo AB Phone: +4670 721 12 80 Email: [email protected] About Bioservo Bioservo AB is a world-leading company in wearable muscle-strengthening systems for people who need extra strength and endurance. Our innovative products and systems are designed to improve the quality of life for our users and make them feel safe and independent. The company has a unique global position in soft active exoskeletons for the hand, which give people back the ability to manage their everyday lives and become independent and able to perform their tasks while maintaining health. Bioservo AB is a Swedish limited company headquartered in Kista, north of Stockholm.For more information, please visit This information was brought to you by Cision The following files are available for download: SOURCE Bioservo AB

NEWTON, Mass.--(BUSINESS WIRE)-- Abcuro, Inc., a clinical-stage biotechnology company developing therapies for the treatment of autoimmune diseases and cancer through precise modulation of cytotoxic T and NK cells, today announced the appointment of Mark Pruzanski, M.D., as Chairman of its Board of Directors. Dr. Pruzanski brings more than 30 years of experience as a life sciences executive, entrepreneur and investor. “We are thrilled to welcome Mark as the Chairman of the Board during a pivotal stage for Abcuro as we continue to advance our registrational Phase 2/3 MUSCLE clinical study for the treatment of inclusion body myositis,” said Alex Martin, Chief Executive Officer of Abcuro. “Mark is a biotech leader with a proven record in bringing innovative new medicines to market for patient populations with unmet medical needs. His operational and financial expertise will be invaluable as we continue developing ulviprubart (ABC008) and expand our therapeutic pipeline.” “I am excited to join Abcuro’s Board at this important time in the Company’s life cycle,” said Dr. Pruzanski. “I look forward to partnering and working closely with this talented Board and management team to help ensure the success of their leading programs addressing diseases for which there are few, if any, treatment options available.” Until its recent acquisition by Eli Lilly and Company, Dr. Pruzanski served as the Chairman and Chief Executive Officer of Versanis Bio, focused on the development of new medicines for the treatment of obesity and other cardiometabolic diseases. Prior to joining Versanis, Dr. Pruzanski founded Intercept Pharmaceuticals and was the company’s Chief Executive Officer until 2021, having led its evolution from drug discovery stage to a global development and commercial organization. While at Intercept, he pioneered novel surrogate endpoints supporting accelerated approval in chronic liver diseases, gaining multiple regulatory approvals for the autoimmune disease PBC and championing the development of therapeutics for NASH. Dr. Pruzanski is an active board member for several biotechnology companies and healthcare organizations, including the Emerging Company Section of the Biotechnology Innovation Organization (BIO). Earlier in his career, he worked in life sciences investment and venture capital, having co-founded Apple Tree Partners. Dr. Pruzanski earned his M.D. from McMaster University Medical School and his M.A. in International Affairs from John Hopkins University. About Abcuro Abcuro is a clinical stage biotechnology company developing first-in-class immunotherapies for the treatment of autoimmune diseases and cancer through precise modulation of highly cytotoxic T and NK cells. The company’s lead program is ulviprubart (ABC008) and is currently in clinical trials for inclusion body myositis (IBM) and T cell large granular lymphocytic leukemia. For more information, visit us on LinkedIn and at abcuro.com.

NEWTON, Mass.--(BUSINESS WIRE)-- Abcuro, Inc., a clinical-stage biotechnology company developing therapies for the treatment of autoimmune diseases and cancer through precise modulation of cytotoxic T and NK cells, today announced initiation of Part B of the registrational Phase 2/3 MUSCLE clinical study, an ongoing clinical trial of ulviprubart (ABC008) for the treatment of inclusion body myositis (IBM). The decision to advance to Part B and continue the trial without modification was made after positive review and recommendation by an independent Data Safety Monitoring Board (DSMB). “Advancing to Part B of the Phase 2/3 MUSCLE clinical trial, combined with the positive DSMB review of the data to date, is an important milestone for both Abcuro and IBM patients. There are currently no therapeutic options to treat IBM, and we believe in the potential of ulviprubart (ABC008), a first-in-class anti-KLRG1 antibody product candidate, to truly transform the lives of patients,” said H. Jeffrey Wilkins, M.D., Chief Medical Officer of Abcuro. The Phase 2/3 MUSCLE clinical trial (NCT05721573) is a randomized, double-blind, placebo-controlled, parallel multicenter trial evaluating ulviprubart (ABC008) in patients with IBM. The three-part, registrational Phase 2/3 clinical trial will enroll more than 200 patients across 30 global sites. Part A of the trial involved enrollment of a sentinel safety cohort in which subjects underwent safety and tolerability review by a DSMB after 20 weeks of treatment. Following a positive DSMB review, the trial is now progressing to Part B of the trial, with the main purpose being the evaluation of the efficacy, safety, and tolerability of two dose levels of ulviprubart (ABC008) (0.5 mg/kg and 2.0 mg/kg) compared with placebo at 76 weeks in subjects with IBM. Part C of the trial will provide pharmacodynamic follow-up for subjects who discontinue treatment. About Ulviprubart (ABC008) Ulviprubart (ABC008) is a first-in-class anti-KLRG1 antibody product candidate capable of selectively depleting highly cytotoxic T cells, while sparing naïve, regulatory and central memory T cells. Ulviprubart (ABC008) is designed to treat diseases mediated by highly cytotoxic T cells, including the autoimmune muscle disease inclusion body myositis (IBM), T cell large granular lymphocytic leukemia (T-LGLL), and mature T cell malignancies. The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have each granted Orphan Drug Designation to ulviprubart (ABC008) for the treatment of IBM. About Inclusion Body Myositis (IBM) IBM is an autoimmune disease in which highly cytotoxic T cells chronically attack muscle tissue leading to progressive weakness and limb muscle atrophy. Patients progressively lose muscle function, including loss of grip and dexterity and loss of mobility. There are currently no available disease-modifying treatment options for IBM. Based on published epidemiology literature, about 50,000 patients suffer from IBM across the US and Europe. About Abcuro Abcuro is a clinical stage biotechnology company developing first-in-class immunotherapies for the treatment of autoimmune diseases and cancer through precise modulation of highly cytotoxic T and NK cells. The company’s lead program is ulviprubart (ABC008) and is currently in clinical trials for inclusion body myositis (IBM) and T cell large granular lymphocytic leukemia. For more information, visit us on LinkedIn and at abcuro.com. View source version on businesswire.com: Contacts Matthew DeYoung Investor Relations and Media Argot Partners abcuro@argotpartners.com Source: Abcuro, Inc. View this news release online at: