Author Interviews, Eli Lilly, Gastrointestinal Disease / 03.11.2023

MedicalResearch.com Interview with: Lotus Mallbris, M.D., Ph.D., Senior Vice President of Immunology Development Eli Lilly MedicalResearch.com: Would you briefly describe the condition of Crohn's disease and who is most susceptible to this disease? Response: Crohn's disease is a form of inflammatory bowel disease (IBD) that can cause systemic inflammation manifested as abdominal pain, diarrhea, fever and weight loss. It can lead to intestinal obstruction, fibrosis and other complications. Approximately 900,000 patients in the U.S. and 1 million patients in Europe are currently suffering from Crohn’s disease, and 70% of those have moderate to severe disease. Although the majority of patients are started on conventional therapy such as corticosteroids and immunomodulators, many will unfortunately progress to having moderate to severe disease. Furthermore, current therapies to treat Crohn’s disease often fail to achieve remission for a majority of patients, and of the patients who do achieve remission, a substantial proportion lose it within the first year. (more…)
Author Interviews, Eli Lilly, Gastrointestinal Disease, NEJM / 02.11.2023

MedicalResearch.com Interview with: Marla C. Dubinsky, MD Professor of Pediatrics and Medicine Icahn School of Medicine at Mount Sinai Co- director, Susan and Leonard Feinstein IBD Clinical Center Mount Sinai Health System MedicalResearch.com: What is the background for this study? Would you briefly describe the condition of UC? Response: Lucent 1 and Lucent 2 were the induction and maintenance registration trials studying the efficacy and safety of mirikizumab in patients 18 years and older with moderate to severely active ulcerative colitis. Mirikizumab is a monoclonal antibody targeting the p19 subunit of IL23. Lucent-3 is the open label extension arm for those meeting inclusion criteria after completing Lucent 2. This study evaluated the long term efficacy and safety of mirikizumab in patients with ulcerative colitis who completed a total of 104 weeks of active mirikizumab treatment. Ulcerative colitis is a chronic incurable inflammatory condition of colon. Common symptoms include diarrhea, blood in the stool, abdominal cramping and bowel urgency. Bowel urgency is one of the most burdensome symptoms that a patient with you could experience. (more…)
Author Interviews, Dermatology, Immunotherapy / 18.07.2023

MedicalResearch.com Interview with: Emma Guttman-Yassky, M.D., PhD, Lead investigator of this study Waldman Professor and System Chair Kimberly and Eric J. Waldman Department of Dermatology Icahn School of Medicine at Mount Sinai, NY   MedicalResearch.com: What is the background for this study? Response: The idea to test how spacing out treatment or even stopping it affects treatment responses once patients are well controlled. Lebrikizumab it is a potent biologic agent with a relatively long-lasting effect. (more…)
Author Interviews, Dermatology, Eli Lilly, Immunotherapy / 18.05.2023

MedicalResearch.com Interview with: Lotus Mallbris, MD PhD Dermatologist andSenior Vice President Global Immunology Development and Medical Affairs  Lilly   MedicalResearch.com: What is the background for this study?  Would you briefly describe what is meant by atopic dermatitis and types treated in this study? Response: First, this study specifically evaluated lebrikizumab, a novel, investigational, monoclonal antibody that selectively binds to interleukin 13 (IL-13) with high-affinity and high potency. Inflammation due to over-activation of the IL-13 pathway plays a central role in the pathogenesis of moderate-to-severe atopic dermatitis, commonly called eczema. This secondary analysis focused on patients treated with lebrikizumab from the 16-week induction periods of the ADvocate 1 and ADvocate 2 studies and the ADhere study. In the trials, we assessed the presence or absence of face or hand dermatitis in patients with moderate-to-severe atopic dermatitis. If present at baseline, at 16 weeks, clinicians assessed the change from baseline on a scale of cleared, improved, no change, or worsened. Only patients with face and hand dermatitis were evaluated as part of the analysis. (more…)
Author Interviews, Gastrointestinal Disease, Immunotherapy / 17.05.2023

MedicalResearch.com Interview with: Marla Dubinsky, M.D. Professor of Pediatrics and Medicine Co-director of the Susan and Leonard Feinstein IBD Clinical Center Chief of the Division of Pediatric Gastroenterology and Nutrition Icahn School of Medicine at Mount Sinai     MedicalResearch.com: What is the background for this study? How does MIRIKIZUMAB differ from other medications for UC? Response: This is a phase 2 study to assess the PK (pharamcokinetics), safety and efficacy of mirikizumab in pediatric ulcerative colitis (UC). Mirikizumab is a humanized monoclonal antibody that specifically binds to the p19 subunit of interleukin-23, a key inflammatory mediator in inflammatory bowel disease. (more…)
Author Interviews, Diabetes, Kidney Disease / 08.06.2022

MedicalResearch.com Interview with: prof. dr. H.J. (Hiddo) Lambers Heerspink Clinical Pharmacologist Department Clinical Pharmacy and Pharmacology University Medical Center Groningen Groningen  MedicalResearch.com:  What is the background for this study?    Response: Tirzepatide is a novel GIP-GLP1 receptor agonist recently FDA approved for the treatment of type 2 diabetes. The SURPASS_4 trial demonstrated that in patients with type 2 diabetes at high cardiovascular risk tirzepatide compared to insulin glargine markedly reduces Hba1c and body weight. About 1 out of 3 patients with type 2 diabetes and CV disease has kidney disease and these patients are at high risk of kidney failure. The aim of this study was to assess whether tirzepatide could slow CKD progression in high risk individuals with type 2 diabetes participating in the SURPASS 4 trial.  (more…)
Alzheimer's - Dementia, Author Interviews, Eli Lilly, NEJM / 16.03.2021

MedicalResearch.com Interview with: Stephen Salloway, M.D., M.S. Director of Neurology and the Memory and Aging Program, Butler Hospital Martin M. Zucker Professor of Psychiatry and Human Behavior Professor of Neurology, Alpert Medical School of Brown University Providence, RI 02906  MedicalResearch.com: What is the background for this study? Response: This 78 week phase 2 study tested donanemab in patients with early Alzheimer’s disease. Donanemab is a an anti-amyloid monoclonal antibody that targets the N3 pyroglutamate epitope.  MedicalResearch.com: What are the main findings? Response: The drug produced a substantial lowering of amyloid plaques and showed a slowing in cognitive decline. Key innovations included using PET scans to ensure all patients were amyloid positive and had a moderate level of tau build-up and switching from drug to placebo once the amyloid level was below the expected cut-off for Alzheimer’s disease. There were no new safety signals. The main side-effect was amyloid-related imaging abnormalities (ARIA) that have been seen with other anti-amyloid treatments. ARIA is managed with regular safety MRI scans.  Donanemab is now being tested in a larger phase 3 trial that could lead to regulatory approval. (more…)