scholarly journals Emerging Therapeutics Based on the Amino Acid Neurotransmitter System: An Update on the Pharmaceutical Pipeline for Mood Disorders

2021 ◽  
Vol 5 ◽  
pp. 247054702110204
Author(s):  
Julia Hecking ◽  
Pasha A. Davoudian ◽  
Samuel T. Wilkinson
Keyword(s):  
Amino Acid ◽  
Mood Disorders ◽  
Phase Iii ◽  
Public Health Issue ◽  
Complex Nature ◽  
Novel Therapies ◽  
Amino Acid Neurotransmitters ◽  
Neurotransmitter System ◽  
Phase Iii Clinical Trials ◽  
The World

Mood disorders represent a pressing public health issue and significant source of disability throughout the world. The classical monoamine hypothesis, while useful in developing improved understanding and clinical treatments, has not fully captured the complex nature underlying mood disorders. Despite these shortcomings, the monoamine hypothesis continues to dominate the conceptual framework when approaching mood disorders. However, recent advances in basic and clinical research have led to a greater appreciation for the role that amino acid neurotransmitters play in the pathophysiology of mood disorders and as potential targets for novel therapies. In this article we review progress of compounds that focus on these systems. We cover both glutamate-targeting drugs such as: esketamine, AVP-786, REL-1017, AXS-05, rapastinel (GLYX-13), AV-101, NRX-101; as well as GABA-targeting drugs such as: brexanolone (SAGE-547), ganaxolone, zuranolone (SAGE-217), and PRAX-114. We focus the review on phase-II and phase-III clinical trials and evaluate the extant data and progress of these compounds.

scholarly journals SARS-CoV-2 Targets and COVID-19 Vaccines

COVID ◽  
2021 ◽  
Vol 1 (3) ◽  
pp. 608-621
Author(s):  
Arthur W. Currier ◽  
Madeline C. Jeshurin ◽  
Valerie B. Sampson
Keyword(s):  
Protective Immunity ◽  
Vaccine Development ◽  
Phase Iii ◽  
World Health ◽  
Vaccine Candidates ◽  
Phase Iii Clinical Trials ◽  
The World ◽  
Health Organization ◽  
Protection Against Infection

Coronavirus disease-2019 (COVID-19) vaccines are being used across the globe to reduce the risk of developing COVID-19, stop the transmission of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), and end the pandemic. To address this, a massive global effort is underway for development of COVID-19 vaccines. As of September 2021, the World Health Organization (WHO) has documented 331 COVID-19 vaccine candidates, and 107 are in clinical evaluation, with 8 in Phase IV and 30 in Phase III clinical trials (WHO; COVID-19 vaccine tracker). At least 13 different vaccines are being issued for emergency use authorization. Specifically, the goal is to produce protective immunity to SARS-CoV-2 infection by stimulating an immune response to either the whole virus, viral protein, or nucleic acid products. The spike (S) proteins of SARS-CoV-2 that give the characteristic “corona” appearance of this family of viruses has emerged as an effective target for vaccines. Other viral candidates that are being developed also aim to produce immunity for COVID-19. In this review, we describe the different vaccine platforms, target candidates for vaccines, and their progress in COVID-19 vaccine development. This is critical since newly discovered SARS-CoV-2 variants of interest require understanding of how vaccines may provide the most effective long-term protection against infection.

scholarly journals COVID-19 Vaccine Race: An Overview and Update

2021 ◽  
Vol 11 (2) ◽  
pp. 171-177
Author(s):  
Md. Rayhan Chowdhury ◽  
Shirmin Islam ◽  
Mohammad Nurul Matin
Keyword(s):  
Clinical Trial ◽  
Vaccine Development ◽  
Vaccine Candidate ◽  
Clinical Trial Data ◽  
Trial Data ◽  
Phase Iii ◽  
Health Crisis ◽  
Phase Iii Clinical Trials ◽  
Successful Vaccine ◽  
The World

A sudden health crisis has shut down the entire world for almost a year due to a new virus called Covid-19 and thus the WHO has declared the COVID-19 as a pandemic disease. As vaccines stimulate the immune system to fight against future infections, thereby conferring immunity, so far, vaccine development in a race throughout the world. Therefore, disseminating the overview of the vaccine development at present with their critical situation for COVID-19 is the aim of this review. The world is looking eagerly for a potential vaccine candidate that can save every life. Here, we reported the overview of the possible types of vaccines against Covid-19 as well as a glimpse of vaccine race with different phases of clinical trial data, comparison of the rate of success of phase-III clinical trials and their safety, and drawbacks with the present status. We have studied literature from clinical trial data of respective vaccine candidates published in the journals and collected data from databases dedicated to corona vaccine and the vaccine company's website to enrich our review and aiming to focus on clinical trial data stages, how consequences it faces, and how to position it belongs towards a successful vaccine candidate. Keywords: COVID-19, SARS-CoV-2, COVID-19 vaccine, Clinical trial.

Rome I versus Rome II; Overlap in patients enrolled in tegaserod phase III clinical trials for irritable bowel syndrome (IBS)

2001 ◽  
Vol 120 (5) ◽  
pp. A284-A284
Author(s):  
B NAULT ◽  
S SUE ◽  
J HEGGLAND ◽  
S GOHARI ◽  
G LIGOZIO ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Irritable Bowel Syndrome ◽  
Phase Iii ◽  
Phase Iii Clinical Trials ◽  
Irritable Bowel ◽  
Rome I

Neovastat, a naturally occurring multifunctional antiangiogenic drug, in phase III clinical trials

2001 ◽  
Vol 28 (6) ◽  
pp. 620-625 ◽  
Author(s):  
Pierre Falardeau ◽  
Pierre Champagne ◽  
Patrick Poyet ◽  
Claude Hariton ◽  
[Eacute]ric Dupont
Keyword(s):  
Clinical Trials ◽  
Phase Iii ◽  
Phase Iii Clinical Trials ◽  
Naturally Occurring ◽  
Antiangiogenic Drug

The Integral Nature of Ethnicity and Religion during Northern Ireland’s Troubles

2018 ◽  
Vol 41 (1-2) ◽  
pp. 9-18
Author(s):  
Peter Crowley
Keyword(s):  
Religious Identity ◽  
Historical Narratives ◽  
Complex Nature ◽  
Political Rights ◽  
The Troubles ◽  
Religious Conflicts ◽  
The World ◽  
Sectarian Conflict ◽  
Civil And Political Rights ◽  
Religious Other

Northern Ireland’s Troubles conflict, like many complex conflicts through the world, has often been conceived as considerably motivated by religious differences. This paper demonstrates that religion was often integrated into an ethno-religious identity that fueled sectarian conflict between Protestants and Catholics in Northern Ireland during the Troubles period. Instead of being a religious-based conflict, the conflict derived from historical divides of power, land ownership, and civil and political rights in Ireland over several centuries. It relies on 12 interviews, six Protestants and six Catholics, to measure their use of religious references when referring to their religious other. The paper concludes that in the overwhelming majority of cases, both groups did not use religious references, supporting the hypothesis on the integrated nature of ethnicity and religion during the Troubles. It offers grounding for looking into the complex nature of sectarian and seemingly religious conflicts throughout the world, including cases in which religion acts as more of a veneer to deeply rooted identities and historical narratives.

Old Drugs with New Tricks; Paradigm in Drug Development Pipeline for Alzheimer’s Disease

2020 ◽  
Vol 20 ◽  
Author(s):  
Tanay Dalvi ◽  
Bhaskar Dewangan ◽  
Rudradip Das ◽  
Jyoti Rani ◽  
Suchita Dattatray Shinde ◽  
...  
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Drug Development ◽  
Molecular Targets ◽  
Drug Repurposing ◽  
Phase Iii ◽  
Complex Nature ◽  
New Drug ◽  
Development Pipeline ◽  
Old Drugs

: The most common reason behind dementia is Alzheimer’s disease (AD) and it is predicted to be the third lifethreatening disease apart from stroke and cancer for the geriatric population. Till now only four drugs are available in the market for symptomatic relief. The complex nature of disease pathophysiology and lack of concrete evidences of molecular targets are the major hurdles for developing new drug to treat AD. The the rate of attrition of many advanced drugs at clinical stages, makes the de novo discovery process very expensive. Alternatively, Drug Repurposing (DR) is an attractive tool to develop drugs for AD in a less tedious and economic way. Therefore, continuous efforts are being made to develop a new drug for AD by repursing old drugs through screening and data mining. For example, the survey in the drug pipeline for Phase III clinical trials (till February 2019) which has 27 candidates, and around half of the number are drugs which have already been approved for other indications. Although in the past the drug repurposing process for AD has been reviewed in the context of disease areas, molecular targets, there is no systematic review of repurposed drugs for AD from the recent drug development pipeline (2019-2020). In this manuscript, we are reviewing the clinical candidates for AD with emphasis on their development history including molecular targets and the relevance of the target for AD.

Loss of sleep or loss of dark?

2018 ◽  
Author(s):  
Richard G. Stevens
Keyword(s):  
Mood Disorders ◽  
Deep Sea ◽  
Short Distance ◽  
Water Surface ◽  
Ocean Floor ◽  
Physiological Adaptation ◽  
Poor Sleep ◽  
Short Period ◽  
The World ◽  
Night And Day

Before electricity, night was something akin to the deep sea: just as we could not descend much below the water surface, we also could not investigate the night for more than a short distance, and for a short period of time. Things changed with two inventions: the Bathysphere to plumb the ocean floor, and electricity to light the night for sustained exploration. Exploration led to dominance, and night has become indistinguishable from day in many parts of the world. The benefits of electric light are myriad, but so too are the possible detriments of loss of dark at night, including poor sleep, obesity, diabetes, cancer, and mood disorders. Our primordial physiological adaptation to the night and day cycle is being flummoxed by the maladaptive signals coming from electric lighting around the clock. The topic of sleep and health has finally attained scientific respect, but dark and health is not yet fully appreciated.

scholarly journals Animal and Human Vaccines against West Nile Virus

Pathogens ◽  
2020 ◽  
Vol 9 (12) ◽  
pp. 1073
Author(s):  
Juan-Carlos Saiz
Keyword(s):  
Clinical Trials ◽  
West Nile Virus ◽  
Vaccine Development ◽  
Phase Iii ◽  
West Nile ◽  
Specific Therapy ◽  
Phase Iii Clinical Trials ◽  
Neuroinvasive Disease ◽  
The Us ◽  
The Status

West Nile virus (WNV) is a widely distributed enveloped flavivirus transmitted by mosquitoes, which main hosts are birds. The virus sporadically infects equids and humans with serious economic and health consequences, as infected individuals can develop a severe neuroinvasive disease that can even lead to death. Nowadays, no WNV-specific therapy is available and vaccines are only licensed for use in horses but not for humans. While several methodologies for WNV vaccine development have been successfully applied and have contributed to significantly reducing its incidence in horses in the US, none have progressed to phase III clinical trials in humans. This review addresses the status of WNV vaccines for horses, birds, and humans, summarizing and discussing the challenges they face for their clinical advance and their introduction to the market.

scholarly journals The role of future treatments in the management of neovascular age-related macular degeneration in Europe

2021 ◽  
pp. 112067212110183
Author(s):  
Laurent Kodjikian ◽  
Carl Joe Mehanna ◽  
Salomon-Yves Cohen ◽  
François Devin ◽  
Sam Razavi ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Macular Degeneration ◽  
Age Related Macular Degeneration ◽  
Phase Iii ◽  
Vascular Endothelial ◽  
Real World Data ◽  
Phase Iii Clinical Trials ◽  
Age Related ◽  
Injection Frequency ◽  
Endothelial Growth Factor

Anti-vascular endothelial growth factor (VEGF) agents have transformed the management of patients with neovascular age-related macular degeneration (nAMD) over the past two decades. However, as more long-term real-world data become available, it is clear that treatment outcomes are inferior to those reported in large, controlled clinical trials. This is largely driven by undertreatment, that is, not maintaining a consistent injection frequency to achieve sustained VEGF suppression, whether due to patient non-compliance, an important injection burden, or non/incomplete anatomical response. Newer therapeutic advances under evaluation hold promise in achieving more, for less. We review the latest drugs currently in or having successfully finished phase III clinical trials, and determine their potential place in the management of patients with nAMD in Europe.

scholarly journals Matching comparisons of therapeutic efficacy suggest better clinical outcomes for patients treated with peginterferon beta-1a than with glatiramer acetate

2021 ◽  
Vol 14 ◽  
pp. 175628642097591
Author(s):  
Thomas F. Scott ◽  
Ray Su ◽  
Kuangnan Xiong ◽  
Arman Altincatal ◽  
Carmen Castrillo-Viguera ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Propensity Score ◽  
Clinical Outcomes ◽  
Glatiramer Acetate ◽  
Therapeutic Efficacy ◽  
Individual Patient Data ◽  
Patient Data ◽  
Phase Iii ◽  
Lower Probability ◽  
Phase Iii Clinical Trials

Background: Peginterferon beta-1a and glatiramer acetate (GA) are approved first-line therapies for the treatment of relapsing forms of multiple sclerosis, but their therapeutic efficacy has not been compared directly. Methods: Clinical outcomes at 2 years, including no evidence of disease activity (NEDA), for patients receiving peginterferon beta-1a 125 mcg every 2 weeks (Q2W) or GA 20 mg/ml once daily (QD) were compared by propensity score matching analysis using individual patient data from ADVANCE and CONFIRM phase III clinical trials. In addition, clinical outcomes at 1–3 years for patients receiving peginterferon beta-1a Q2W or GA 40 mg/ml three times a week (TIW) were evaluated using a matching-adjusted comparison analysis of individual patient data from ADVANCE and the ADVANCE extension study, ATTAIN, and aggregate patient data from the phase III GALA and the GALA extension studies. Results: Propensity-score-matched peginterferon beta-1a patients ( n = 336) had a significantly lower annualized relapse rate [ARR (0.204 versus 0.282); rate ratio = 0.724; p = 0.045], a significantly lower probability of 12-week confirmed disability worsening (10.0% versus 14.6%; hazard ratio = 0.625; p = 0.048), and a significantly higher rate of NEDA (20.3% versus 11.5%; p = 0.047) compared with GA 20 mg/ml QD patients after 2 years of treatment. Matching-adjusted peginterferon beta-1a patients (effective n = 276) demonstrated a similar ARR at 1 year (0.278 versus 0.318; p = 0.375) and significantly lower ARR at 2 years (0.0901 versus 0.203; p = 0.032) and 3 years (0.109 versus 0.209; p = 0.047) compared with GA 40 mg/ml TIW patients ( n = 834). Conclusion: Results from separate matching comparisons of phase III clinical trials and extension studies suggest that peginterferon beta-1a 125 mcg Q2W may provide better clinical outcomes than GA (20 mg/ml QD or 40 mg/ml TIW).

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