Journals Expert Opinion on Investigatio...

Expert Opinion on Investigational Drugs
Jian Liu, Qingwei Zhao, You Zhai, Xia Wu, Jiejing Kai, Jie Ruan, Minglan Wu, Meijia Wu, Zhuojun Zhou, Yuemei Yan, Jinzi J Wu, Yunqing Qiu
BACKGROUND: Considering the rise of new SARS-CoV-2 variants that have reduced the efficacy of COVID-19 vaccines, the development of new antiviral medications for the disease has become increasingly necessary. In this study, ASC10, a novel antiviral prodrug, was studied in a phase 1 trial in healthy Chinese participants. RESEARCH DESIGN AND METHODS: Part 1 involved 60 participants, receiving 50-800 mg ASC10 or placebo twice daily for 5.5 days. Part 2, with 12 participants, explored ASC10 dosing in the fed/fasting states...
July 11, 2024: Expert Opinion on Investigational Drugs
Robert H Gaffey, Afua K Takyi, Alpana Shukla
INTRODUCTION: One billion people live with obesity. The most promising medications for its treatment are incretin-based therapies, based on enteroendocrine peptides released in response to oral nutrients, specifically glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic peptide (GIP). The mechanisms by which GLP-1 receptor agonism cause weight reduction are becoming increasingly understood. However, the mechanisms by which GIP receptor-modulating medications cause weight loss remain to be clarified...
July 10, 2024: Expert Opinion on Investigational Drugs
Alina Sprenger-Svačina, Martin K R Svačina, Tong Gao, Gang Zhang, Kazim A Sheikh
INTRODUCTION: Guillain-Barré syndrome (GBS) is a monophasic immune neuropathic disorder characterized by acute paralysis. A significant portion of patients are left with residual deficits, which presents a considerable global healthcare challenge. The precise mechanisms underlying GBS pathogenesis are not fully elucidated. Recent studies have focused on postinfectious molecular mimicry and identified involvement of IgG autoantibodies and innate immune effectors in GBS. Intravenous immunoglobulins (IVIg) and plasma exchange (PE) are two established evidence-based immunomodulatory treatments for GBS, but a significant proportion of GBS patients fails to respond adequately to either therapy...
July 10, 2024: Expert Opinion on Investigational Drugs
Jinyi Chen, Lanting Hu, Zhenjie Liu
INTRODUCTION: Abdominal aortic aneurysm is a progressive, segmental, abdominal aortic dilation associated with a high mortality rate. Abdominal aortic aneurysms with diameters larger than 55 mm are associated with a high risk of rupture, and the most effective treatment options are surgical repair. Close observation and lifestyle adjustments are recommended for smaller abdominal aortic aneurysms with lower rupture risk. The development of medical therapies that limit or prevent the progression, expansion, and eventual rupture of abdominal aortic aneurysms remains an unmet clinical need...
July 8, 2024: Expert Opinion on Investigational Drugs
Na Hyun Kim, Mehdi Hamadani, Sameem Abedin
INTRODUCTION: Steroid-refractory acute graft-versus-host disease (SR-aGVHD) remains a formidable obstacle in the field of allogeneic hematopoietic cell transplantation (allo-HCT), significantly contributing to patient morbidity and mortality. The current therapeutic landscape for SR-aGVHD is limited, often yielding suboptimal results, thereby emphasizing the urgent need for innovative and effective treatments. AREAS COVERED: In light of the pivotal REACH2 trial, ruxolitinib phosphate, a Janus kinase inhibitor, has gained prominence as the standard treatment for SR-aGVHD...
July 8, 2024: Expert Opinion on Investigational Drugs
William C Upshaw, John M Richey, Gurjot Ravi, Adrian Chen, Shahab Ahmadzadeh, Sahar Shekoohi, Omar Viswanath, Alan D Kaye
INTRODUCTION: LX-9211 is a drug designed to treat neuropathic pain conditions. It functions by inhibiting the adaptor-associated kinase 1 (AAK1) enzyme which promotes clathrin-dependent endocytosis. Preclinical studies have shown that LX-9211 does produce a reduction in nociceptive related behaviors and produces no major adverse effects in rats. Thus, LX-9211 has advanced to clinical trials to assess its safety and efficacy in humans. So far, phase 1 and phase 2 clinical trials involving patients with postherpetic neuralgia and diabetic peripheral neuropathic pain have been conducted with phase 3 trials planned in the future...
July 8, 2024: Expert Opinion on Investigational Drugs
Marco Sebastiani, Andreina Manfredi, Stefania Croci, Paola Faverio, Giulia Cassone, Caterina Vacchi, Carlo Salvarani, Fabrizio Luppi
INTRODUCTION: Pulmonary involvement is one of the most common extra-articular manifestations of rheumatoid arthritis (RA), a systemic inflammatory disease characterized by joint swelling and tenderness. All lung compartments can be interested in the course of RA, including parenchyma, airways, and, more rarely, pleura and vasculature. AREAS COVERED: The aim of this paper is to review the main RA lung manifestations, focusing on pathogenesis, clinical and therapeutic issues of RA-related interstitial lung disease (ILD)...
July 5, 2024: Expert Opinion on Investigational Drugs
Crimini Edoardo, Curigliano Giuseppe
INTRODUCTION: Antibody-drug conjugates (ADCs) represent a revolutionary approach in the systemic treatment for both solid and hematologic tumors. Constituted by an antibody, a cytotoxic payload, and a linker, ADCs aim to selectively deliver cytotoxic agents to tumors while sparing normal tissues. Various ADCs have been tested and approved for multiple solid tumors so far, but if there is one that had a major impact on clinical practice, this is Trastuzumab-deruxtecan (T-DXd). Notably, T-DXd was approved for HER2-positive and HER2-low metastatic breast cancer (MBC), HER2-positive gastric cancer (GC), HER2-mutant non-small cell lung cancer (NSCLC) and HER2 3+ solid tumors...
July 5, 2024: Expert Opinion on Investigational Drugs
Claudio Cruciani, Marile Gatto, Luca Iaccarino, Andrea Doria, Margherita Zen
INTRODUCTION: the advent of biological therapies has already revolutionized treatment strategies and disease course of several rheumatologic conditions, and monoclonal antibodies (mAbs) targeting cytokines and interleukins represent a considerable portion of this family of drugs. In Systemic Lupus Erythematosus (SLE) dysregulation of different cytokine and interleukin-related pathways have been linked to disease development and perpetration, offering palatable therapeutic targets addressable via such mAbs...
July 3, 2024: Expert Opinion on Investigational Drugs
Lorenza Magagnoli, Paola Ciceri, Mario Cozzolino
INTRODUCTION: Secondary hyperparathyroidism (SHPT) is a common complication of chronic kidney disease (CKD). It begins as an adaptive increase in parathyroid hormone levels to prevent calcium and phosphate derangements. Over time, this condition becomes maladaptive and is associated with increased morbidity and mortality. Current therapies encompass phosphate-lowering strategies, vitamin D analogues, calcimimetics and parathyroidectomy. These approaches harbor inherent limitations, stimulating interest in the development of new drugs for SHPT to overcome these limitations and improve survival and quality of life among CKD patients...
June 16, 2024: Expert Opinion on Investigational Drugs
Luca Iorio, Roberto Padoan, Milena Bond, Christian Dejaco
INTRODUCTION: Polymyalgia rheumatica (PMR) is an inflammatory rheumatic disorder characterized by pain and stiffness in the shoulder and pelvic girdles, constitutional symptoms, and elevated acute-phase reactants. Glucocorticoids (GCs) remain the first-choice treatment for PMR, but relapses are common. Identification of steroid-sparing agents is therefore of utmost importance. AREAS COVERED: The efficacy of conventional immunosuppressive drugs is controversial. The use of interleukin (IL)-6 receptor inhibitors proved to be effective and safe in treating PMR patients...
June 16, 2024: Expert Opinion on Investigational Drugs
Amanda J Hooper, Xuan L Tang, John R Burnett
No abstract text is available yet for this article.
June 15, 2024: Expert Opinion on Investigational Drugs
Eric F Morand, Marilyn Pike, J Merrill, Ronald F van Vollenhoven, Victoria P Werth, Coburn Hobar, Nikolay Delev, Vaishali Shah, Brian Sharkey, Thomas Wegman, Ian Catlett, Subhashis Banerjee, Shalabh Singhal
No abstract text is available yet for this article.
May 29, 2024: Expert Opinion on Investigational Drugs
Ling Yang, Yuan Fang, Yuan Luo, Meng Fu, Kai Shen, Zhu Luo
OBJECTIVE: SHR-1703 is a novel humanized IgG1 monoclonal antibody with high IL-5 affinity and prolonged half-life, aiming to control eosinophil-related diseases. The study intended to evaluate pharmacokinetics, pharmacodynamics, immunogenicity, safety and tolerability of SHR-1703 in healthy subjects. METHODS: A single-center, randomized, double-blind, placebo-controlled, single-dose escalation phase I study was conducted. 42 subjects were allocated to sequentially receive single subcutaneous injection of 20, 75, 150, 300 and 400 mg SHR-1703 or placebo...
May 28, 2024: Expert Opinion on Investigational Drugs
Ava Aghakhani, Parmida Sadat Pezeshki, Nima Rezaei
INTRODUCTION: Extracellular vesicles (EVs) are membrane-bound nanoparticles for intercellular communication. Subtypes of EVs, namely exosomes and microvesicles transfer diverse, bioactive cargo to their target cells and eventually interfere with immune responses. Despite being a promising approach, cancer immunotherapy currently faces several challenges including immune resistance. EVs secreted from various sources in the tumor microenvironment provoke immune cell exhaustion and lower the efficacy of immunological treatments such as CAR T cells and immune checkpoint inhibitors...
May 25, 2024: Expert Opinion on Investigational Drugs
Shogo Hashimoto, Narihito Nagoshi, Masaya Nakamura, Hideyuki Okano
INTRODUCTION: Spinal cord injury (SCI) is a condition in which the spinal cord parenchyma is damaged by various factors. The mammalian central nervous system has been considered unable to regenerate once damaged, but recent progress in basic research has gradually revealed that injured neural cells can indeed regenerate. Drug therapy using novel agents is being actively investigated as a new treatment for SCI. One notable treatment method is regeneration therapy using hepatocyte growth factors (HGF)...
May 23, 2024: Expert Opinion on Investigational Drugs
Nadia Saoudi González, Paola Valeria Marchese, Iosune Baraibar, Javier Ros, Francesc Salvà, Marta Rodríguez, Clara Salvà, Caterina Vaghi, Adriana Alcaraz, Ariadna García, Josep Tabernero, Elena Élez
INTRODUCTION: The global prevalence of colorectal cancer highlights the need to enhance treatment strategies for improved patient outcomes. The pivotal role of epidermal growth factor receptor (EGFR) signaling in regulating cellular processes for this disease pinpoints its value as a therapeutic target, despite the emergence of resistance mechanisms over time. AREAS COVERED: This review discusses the clinical evidence supporting the use of EGFR inhibitors in molecularly-selected patients based on molecular characteristics (notably BRAF V600E and KRAS G12C) including combination approaches targeting different points in in the signaling pathway, as well as strategies such as EGFR inhibitor rechallenge...
May 22, 2024: Expert Opinion on Investigational Drugs
Sophie E Field, Annabel J Curle, Roger A Barker
INTRODUCTION: Huntington's Disease (HD) is a genetic neurodegenerative disease for which there is currently no disease-modifying treatment. One of several underlying mechanisms proposed to be involved in HD pathogenesis is inflammation; there is now accumulating evidence that the immune system may play an integral role in disease pathology and progression. As such, modulation of the immune system could be a potential therapeutic target for HD. AREAS COVERED: To date, the number of trials targeting immune aspects of HD has been limited...
May 17, 2024: Expert Opinion on Investigational Drugs
Amedeo De Grado, Chiara Pisciotta, Paola Saveri, Davide Pareyson
No abstract text is available yet for this article.
May 7, 2024: Expert Opinion on Investigational Drugs
Prithvi Reddy Akepati, Eric M Gochanour
INTRODUCTION: Up to 40% of Primary biliary cholangitis (PBC) patients have a suboptimal response to Ursodeoxycholic acid (UDCA). Close to half of such patients show a remarkable improvement when additionally treated with Obeticholic acid (OCA) but have a dose-dependent increase of pruritus. This relative success of OCA, a first-in-class Farnesoid receptor (FXR) agonist, has positioned FXR as an attractive target for drug development. Novel candidates have since emerged, providing hope for this subgroup of patients who lack effective and safe treatments...
May 7, 2024: Expert Opinion on Investigational Drugs
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