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Expert Opinion on Investigational Drugs

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https://www.readbyqxmd.com/read/29465257/investigational-drugs-in-development-to-prevent-neuromyelitis-optica-relapses
#1
Friedemann Paul, Olwen Murphy, Santiago Pardo, Michael Levy
In the short time since 2014, three pivotal, worldwide studies in neuromyelitis optica spectrum disorders have been launched: eculizumab, SA237 and inebelizumab, each based on a unique mechanism. Areas covered: In this review, we provide a discussion on the trial data available for each drug, a brief description of the trial design, and our expert opinion on the potential benefits and risks. Expert Opinion: Eculizumab, a C5 complement inhibitor, may prove useful in the treatment of intractable cases of NMOSD, but physicians must be aware of the known risk of meningococcal infection...
February 21, 2018: Expert Opinion on Investigational Drugs
https://www.readbyqxmd.com/read/29455558/investigational-immunosuppressants-in-early-stage-clinical-trials-for-the-treatment-of-multiple-sclerosis
#2
Alberto Gajofatto, Marco Turatti
Multiple sclerosis (MS) is a chronic demyelinating disease of the central nervous system with an immune mediated pathogenesis. Several therapies that suppress or modulate diverse immune system functions have been used for decades with the aim of modifying the disease course. However, these treatments have either limited efficacy or potentially serious adverse events that prevent first-line use on large scale. Areas covered. The aim of the present article is to review ongoing or recently completed clinical trials investigating immunosuppressive drugs for MS...
February 19, 2018: Expert Opinion on Investigational Drugs
https://www.readbyqxmd.com/read/29451410/inclisiran-for-the-treatment-of-dyslipidemia
#3
Toshiyuki Nishikido, Kausik K Ray
Dyslipidemia is one of the most important risk factors for cardiovascular disease. Insufficient reduction in LDL-C from existing therapies in patients at high risk of atherogenic cardiovascular disease is an unmet clinical need. Circulating PCSK9 causes hypercholesterolemia by reducing LDL receptors in hepatocytes. Areas covered: PCSK9 inhibition has emerged as a promising new therapeutic strategy to reduce LDL-C. Inclisiran, a novel, synthetic, siRNA molecule, inhibits PCSK9 synthesis in hepatocytes. Inclisiran targets intracellular PCSK9 synthesis specifically, resulting in a dose-dependent, long-term, significant reduction in LDL-C...
February 16, 2018: Expert Opinion on Investigational Drugs
https://www.readbyqxmd.com/read/29451407/advancements-in-drug-development-for-diarrhea-predominant-irritable-bowel-syndrome
#4
Giovanni Dothel, Maria Raffaell Barbaro, Emanuel Raschi, Giovanni Barbara, Fabrizio De Ponti
Introduction Diarrhea-predominant irritable bowel syndrome (IBS-D) is a common disorder characterized by a complex pathophysiology hampering optimal targeted drug development. Recent advances in our understanding of key underlying mechanisms prompted novel therapeutics including novel pharmacological approaches. Areas covered This review summarizes the latest advancements in the pipeline of IBS-D drugs focusing on new pharmacological targets, efficacy and safety of medicinal products considering the recent harmonization of regulatory requirements by the FDA and the EMA...
February 16, 2018: Expert Opinion on Investigational Drugs
https://www.readbyqxmd.com/read/29448843/cenicriviroc-for-the-treatment-of-non-alcoholic-steatohepatitis-and-liver-fibrosis
#5
Frank Tacke
Nonalcoholic fatty liver disease (NAFLD) has an increasing prevalence worldwide. At present, no specific pharmacotherapy is approved for NAFLD. Simple steatosis and nonalcoholic steatohepatitis (NASH) can progress to liver fibrosis that is associated with mortality in NAFLD. The recruitment of inflammatory monocytes and macrophages via chemokine receptor CCR2 as well as of lymphocytes and hepatic stellate cells via CCR5 promote the progression of NASH to fibrosis. Areas covered: I summarize preclinical and clinical data on the efficacy and safety of the dual CCR2/CCR5 inhibitor cenicriviroc (CVC, also TBR-652 or TAK-652) for the treatment of NASH and fibrosis...
February 16, 2018: Expert Opinion on Investigational Drugs
https://www.readbyqxmd.com/read/29448862/filgotinib-for-the-treatment-of-crohn-s-disease
#6
Remi Labetoulle, Stephane Paul, Xavier Roblin
Inflammatory Bowel Diseases, such as Crohn's disease (CD) and Ulcerative Colitis (UC), are widespread diseases (with an estimated 2.2 million Europeans affected), and even populations previously considered 'low risk' (such as Japan and India) are witnessing an increasing incidence. CD is a chronic, progressive immunologically driven disease, with an evolution characterized by succession of periods of progression and remission. New physiopathological pathways are continuously being discovered, the more we understand about how the disease appears and progresses, the more targets become available for the development of novel therapies...
February 15, 2018: Expert Opinion on Investigational Drugs
https://www.readbyqxmd.com/read/29425474/inhaled-medication-therapy-for-bronchiectasis-status-quo-and-the-next-frontier
#7
Chun-Lan Chen, Yan Huang, Yong-Hua Gao, Rong-Chang Chen, Nan-Shan Zhong, Wei-Jie Guan
No abstract text is available yet for this article.
February 9, 2018: Expert Opinion on Investigational Drugs
https://www.readbyqxmd.com/read/29411655/investigational-drug-therapies-for-coeliac-disease-where-to-from-here
#8
James Haridy, Diana Lewis, Evan D Newnham
Despite decades of research and a detailed knowledge of the immunopathological basis of coeliac disease (CD), adherence to a lifelong gluten-free diet (GFD) remains the single proven and available treatment. The increasing prevalence of CD combined with variable adherence to the GFD in a significant proportion of patients demands new therapeutic strategies. Areas covered: Trial registries, clinicaltrials.gov, pharmaceutical company website searches as well as published data from PubMed and conference proceedings were used to extract the most recent outcomes for CD therapeutics...
February 7, 2018: Expert Opinion on Investigational Drugs
https://www.readbyqxmd.com/read/29363343/fevipiprant-in-the-treatment-of-asthma
#9
Christobelle White, Adam Wright, Christopher Brightling
Asthma is common and in many, particularly those with more severe disease, there remains a substantial unmet need. Success with biologics targeting eosinophilic inflammation underscore the value of treating inflammation in asthma beyond corticosteroids. Fevipiprant (QAW039) is an oral treatment for asthma. It competitively and reversibly antagonises the prostaglandin D2 receptor 2 (DP2) expressed on inflammatory and structural cells. Areas covered: We reviewed fevipiprant's mode of action and efficacy against other current and emerging pharmacological interventions for moderate-to-severe asthma...
January 24, 2018: Expert Opinion on Investigational Drugs
https://www.readbyqxmd.com/read/29353505/expanded-access-to-investigational-drugs-balancing-patient-safety-with-potential-therapeutic-benefits
#10
Elena Fountzilas, Rabih Said, Apostolia M Tsimberidou
Expanded access is the use of an investigational product by patients with serious medical conditions without participation in a clinical trial. It is a complicated process involving the collaboration of many parties and pharmaceutical companies. Ongoing efforts focus on accelerating expanded access procedures in the best interest of patients with cancer. Areas covered: We review the regulatory and ethical challenges encountered in efforts to optimize expanded access. Expert opinion: In the era of personalized medicine, patients may benefit from novel therapeutic agents that demonstrate encouraging results in early studies...
January 22, 2018: Expert Opinion on Investigational Drugs
https://www.readbyqxmd.com/read/29334288/targeted-anti-il-13-therapies-in-asthma-current-data-and-future-perspectives
#11
Polyxeni Ntontsi, Evgenia Papathanassiou, Stelios Loukides, Petros Bakakos, Georgios Hillas
The identification of patients with severe asthma who will benefit from a personalized management approach remains an unmet need. Interleukin-13 (IL-13) is a cytokine possessing a significant role in asthma pathogenesis and progression of disease. Humanised monoclonal antibodies against IL-13 and IL-13 and IL-4 receptors are mainly proposed as add-on therapy in patients with TH2-high inflammation with uncontrolled asthma despite maximum therapy. Areas covered: The role of IL-13 in airway inflammation in severe asthma, the targeted anti-IL-13 therapies and biomarkers that predict response to anti-IL-13 treatment are discussed...
January 19, 2018: Expert Opinion on Investigational Drugs
https://www.readbyqxmd.com/read/29338445/investigational-inhaled-therapies-for-non-cf-bronchiectasis
#12
Sabina Antonela Antoniu
Bronchiectasis not related to cystic fibrosis (non-CF bronchiectasis) are associated with a high unmet therapeutic need due to the lack of specifically authorized medications, especially via the inhalation route. In non-CF bronchiectasis chronic infection with Pseudomonas aeruginosa is common and favored by the persistent local inflammation and viscid sputum production. Therefore inhaled antibiotics, mucolytics or anti-inflammatory agents could represent appropriate therapeutic interventions in this setting Areas covered: This review herein discusses the inhaled therapies currently under investigation for non-CF bronchiectasis and their potential therapeutic positioning in exacerbation versus stable state...
January 17, 2018: Expert Opinion on Investigational Drugs
https://www.readbyqxmd.com/read/29333878/glucagon-receptor-signalling-backwards-and-forwards
#13
Tongzhi Wu, Christopher K Rayner, Chinmay S Marathe, Karen L Jones, Michael Horowitz
No abstract text is available yet for this article.
January 15, 2018: Expert Opinion on Investigational Drugs
https://www.readbyqxmd.com/read/29323575/phase-ii-investigational-oral-drugs-for-the-treatment-of-radio-chemotherapy-induced-oral-mucositis
#14
Stephen T Sonis, Alessandro Villa
Oral mucositis is a significant unmet clinical need for many cancer patients. The biological complexity of mucositis' pathogenesis provides a number of mechanistic targets suitable as pharmacologic targets. The diversity of targets has stimulated drug development in search of an effective intervention. In this paper, we review a range of agents that are currently being evaluated. Areas covered: Drugs for management of oral mucositis vary in formulation, route of administration and biological target. Most propose to interrupt the initiation of injury by suppressing activation of the innate immune response or countering oxidative stress, or minimizing downstream inflammatory responses...
January 11, 2018: Expert Opinion on Investigational Drugs
https://www.readbyqxmd.com/read/29323560/the-prospects-for-combination-therapy-with-capecitabine-in-the-rapidly-evolving-treatment-landscape-of-renal-cell-carcinoma
#15
Mehmet Asim Bilen, Jennifer Wilkinson-Carlisle, Guru Sonpavde
Although significant advances have been made in the treatment of advanced renal cell carcinoma (RCC), patients still develop resistance to standard therapies and require the administration of subsequent lines of treatment. New therapeutic approaches are thus imperative to improve the prognosis for patients with RCC. Areas covered: Based on the current literature, we summarize the treatment of metastatic RCC, including the use of cytotoxic chemotherapy, in this review article. We also review the existing scientific literature regarding the role of capecitabine in the treatment of RCC...
January 11, 2018: Expert Opinion on Investigational Drugs
https://www.readbyqxmd.com/read/29318906/cefiderocol-a-novel-siderophore-cephalosporin
#16
Justin J Choi, Matthew W McCarthy
The emergence of multidrug-resistant bacterial pathogens has led to a global public health emergency and novel therapeutic options and drug-delivery systems are urgently needed. Cefiderocol is a siderophore cephalosporin antibiotic that has recently been developed to combat a variety of bacterial pathogens, including β-lactam- and carbapenem-resistant organisms. Areas covered: This paper provides an overview of the mutational and plasmid-mediated mechanisms of β-lactam and carbapenem resistance, the biochemical pathways of siderophores in bacterial iron metabolism, and how cefiderocol may be able to provide better targeted antimicrobial therapy that escape these drug-resistant mechanisms...
January 10, 2018: Expert Opinion on Investigational Drugs
https://www.readbyqxmd.com/read/29250981/update-on-treatment-for-idiopathic-hypersomnia
#17
Elisa Evangelista, Régis Lopez, Yves Dauvilliers
Idiopathic hypersomnia (IH) is a poorly characterized orphan central disorder of hypersomnolence responsible for excessive daytime sleepiness (EDS), prolonged nighttime sleep and sleep inertia that often require long-term symptomatic stimulant medication. To date, no drug has currently the authorization for the treatment of IH patients worldwide. Areas covered: The authors reviewed data on pharmacological treatment of IH obtained from published literature (Medline/PubMed/Web of Science) and Clinicaltrial.gov database from 1997 to 2017...
January 3, 2018: Expert Opinion on Investigational Drugs
https://www.readbyqxmd.com/read/29271672/ns5b-polymerase-inhibitors-in-phase-ii-clinical-trials-for-hcv-infection
#18
Guglielmo Borgia, Alberto Enrico Maraolo, Salvatore Nappa, Ivan Gentile, Antonio Riccardo Buonomo
Hepatitis C virus (HCV) infection might be the first chronic viral disease to be eradicated without the introduction of a prophylactic vaccine. This is essentially due to therapeutic revolution encapsulated by the advent of direct-acting antivirals (DAA) agents, whose efficacy, safety and tolerability (all oral regimens) have made the previous standard of care (interferon plus ribavirin) a vestige of the past. The new regimens achieve very high response rates and have an excellent tolerability profile. Notwithstanding, the first wave of DAAs has brought over problems regarding costs and failures which warrant research and development of further antiviral molecules...
December 28, 2017: Expert Opinion on Investigational Drugs
https://www.readbyqxmd.com/read/29266973/investigational-opioid-antagonists-for-treating-opioid-induced-bowel-dysfunction
#19
Shilan Mozaffari, Shekoufeh Nikfar, Mohammad Abdollahi
Opioids have been highlighted for their role in pain relief among cancer and non-cancer patients. Novel agents have been investigated to reduce opioid-induced constipation (OIC) as the main adverse effect that may lead to treatment discontinuation. Development of peripherally acting mu-opioid receptor antagonists (PAMORA) has resulted in a novel approach to preserve the efficacy of pain control along with less OIC. Areas covered: Clinical evidence for investigational PAMORAs was reviewed and clinical trials on investigational agents to reduce OIC were included...
December 26, 2017: Expert Opinion on Investigational Drugs
https://www.readbyqxmd.com/read/29262269/drug-development-and-acute-gastrointestinal-infections
#20
Hania Szajewska, Maciej Kołodziej, Jan Łukasik
No abstract text is available yet for this article.
December 20, 2017: Expert Opinion on Investigational Drugs
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