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  1. Article ; Online: Pozelimab, a human monoclonal immunoglobulin for the treatment of CHAPLE disease.

    Kaur, Manmeet / Misra, Saurav

    Journal of basic and clinical physiology and pharmacology

    2024  

    Abstract: The complement is a crucial factor of the innate immune system. However, its activation can lead to various diseases, so it needs to be controlled. In mammals, surface-bound complement regulatory proteins safeguard cells from uncontrolled complement- ... ...

    Abstract The complement is a crucial factor of the innate immune system. However, its activation can lead to various diseases, so it needs to be controlled. In mammals, surface-bound complement regulatory proteins safeguard cells from uncontrolled complement-mediated lysis. One of the human complement regulators is CD55, also known as the decay-accelerating factor (DAF), a single-chain, type I cell surface protein anchored to glycosylphosphatidylinositol (GPI). The genetic loss of the complement regulatory protein CD55 leads to a fatal illness known as CHAPLE disease. The complement and innate immunity become hyperactive in this disease, causing angiopathic thrombosis and protein-losing enteropathy. Patients with CHAPLE disease experience abdominal pain, nausea, vomiting, diarrhea, loss of appetite, weight loss, impaired growth, and swelling. This genetic condition has no known cure, and managing its symptoms can be challenging. Pozelimab, a human monoclonal immunoglobulin IgG4 antibody, is a drug that targets the terminal complement protein C5. The drug has a high affinity for both wild-type and variant human C5. Pozelimab has received designations such as fast track, orphan drug, and rare pediatric disease, making it a significant medical breakthrough. It is currently the only available treatment for this disease. In this review, we have summarized the preclinical and clinical data on pozelimab.
    Language English
    Publishing date 2024-04-11
    Publishing country Germany
    Document type Journal Article ; Review
    ZDB-ID 1071737-7
    ISSN 2191-0286 ; 0792-6855 ; 0334-1534
    ISSN (online) 2191-0286
    ISSN 0792-6855 ; 0334-1534
    DOI 10.1515/jbcpp-2024-0008
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    Zs.A 3207: Show issues Location:
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  2. Article ; Online: A review of an investigational drug retatrutide, a novel triple agonist agent for the treatment of obesity.

    Kaur, Manmeet / Misra, Saurav

    European journal of clinical pharmacology

    2024  Volume 80, Issue 5, Page(s) 669–676

    Abstract: Background: Obesity is one of the critical public health problems in our society. It leads to various health conditions, such as type 2 diabetes mellitus, cardiovascular disease, hypertension, dyslipidaemia, and non-alcoholic fatty liver disease. With ... ...

    Abstract Background: Obesity is one of the critical public health problems in our society. It leads to various health conditions, such as type 2 diabetes mellitus, cardiovascular disease, hypertension, dyslipidaemia, and non-alcoholic fatty liver disease. With the rising incidence of obesity, there is a growing demand for new therapies which can effectively manage body weight and improve health.
    Current evidence: Currently under development, multi-receptor agonist drugs may offer a promising solution to meet this unmet medical need. Retatrutide is a novel triple receptor agonist peptide that targets the glucagon receptor (GCGR), glucose-dependent insulinotropic polypeptide receptor (GIPR), and glucagon-like peptide-1 receptor (GLP-1R). This novel drug has the potential to treat metabolic abnormalities associated with obesity as well as diseases resulting from it due to its distinct mechanism of action. The Phase III trial of this pipeline drug for treating type 2 diabetes mellitus, non-alcoholic fatty liver disease, and obesity started on August 28, 2023. The results of a Phase II clinical trial have demonstrated significant weight reduction in overweight and obese adults. Specifically, the trial reported an average weight loss of 17.5% and 24.4% at 24 and 48 weeks, respectively.
    Conclusions: These findings hold promise for the development of effective weight loss interventions in this population group. There is a need for more phase III studies to provide sufficient clinical evidence for the effectiveness of retatrutide, as current evidence is limited to phase II studies and has yet to prove its worth in a larger population. Here, we aimed to provide an overview of retatrutide's safety and effectiveness in treating obesity.
    MeSH term(s) Humans ; Diabetes Mellitus, Type 2/metabolism ; Drugs, Investigational ; Non-alcoholic Fatty Liver Disease/complications ; Obesity/drug therapy ; Obesity/metabolism ; Weight Loss ; Glucagon-Like Peptide-1 Receptor/agonists ; Glucagon-Like Peptide-1 Receptor/metabolism ; Glucagon-Like Peptide-1 Receptor/therapeutic use
    Chemical Substances Drugs, Investigational ; Glucagon-Like Peptide-1 Receptor
    Language English
    Publishing date 2024-02-17
    Publishing country Germany
    Document type Journal Article ; Review
    ZDB-ID 121960-1
    ISSN 1432-1041 ; 0031-6970
    ISSN (online) 1432-1041
    ISSN 0031-6970
    DOI 10.1007/s00228-024-03646-0
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    Zs.A 672: Show issues Location:
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  3. Article ; Online: Evidences and therapeutic advantages of donanemab in the treatment of early Alzheimer's disease.

    Shukla, Ajay Kumar / Misra, Saurav

    Journal of basic and clinical physiology and pharmacology

    2023  Volume 35, Issue 1-2, Page(s) 25–29

    Abstract: The humanised monoclonal antibody donanemab is being developed to treat early onset Alzheimer's disease (AD). This drug targets N-truncated pyroglutamate amyloid-peptide at position 3 (N3pG), a modified form of deposited amyloid-peptide. The symptoms of ... ...

    Abstract The humanised monoclonal antibody donanemab is being developed to treat early onset Alzheimer's disease (AD). This drug targets N-truncated pyroglutamate amyloid-peptide at position 3 (N3pG), a modified form of deposited amyloid-peptide. The symptoms of Alzheimer's disease include gradual memory loss and other cognitive impairments. This disease is characterized by amyloid plaques, which are formed as a result of an accumulation of amyloid-(A-β) peptides. Despite granting donanemab breakthrough therapy designation in June 2021, the FDA rejected donanemab's accelerated approval application in January 2023, due to inadequate safety data. According to the baseline amyloid level, the time to achieve plaque clearance (amyloid plaque level <24.1 centiloids) varied. Patients with higher baseline levels were more likely to achieve amyloid clearance. The safety of the drug was demonstrated by amyloid-related imaging abnormalities (ARIA), which ranged from 26.1 to 30.5 % in the studies. Clinical trial results have shown that donanemab delays cognitive and functional deterioration in patients with mild to moderate AD. However, it is not yet known whether donenameb offers therapeutic benefits that can change and improve the clinical condition of AD patients. To achieve significant clinical benefits in AD patients with cognitive impairment, further studies may be needed to investigate the interaction between A-β plaque reduction and toxic tau levels.
    MeSH term(s) Humans ; Alzheimer Disease/drug therapy ; Amyloid beta-Peptides ; Antibodies, Monoclonal, Humanized/therapeutic use
    Chemical Substances donanemab ; Amyloid beta-Peptides ; Antibodies, Monoclonal, Humanized
    Language English
    Publishing date 2023-12-06
    Publishing country Germany
    Document type Journal Article ; Review
    ZDB-ID 1071737-7
    ISSN 2191-0286 ; 0792-6855 ; 0334-1534
    ISSN (online) 2191-0286
    ISSN 0792-6855 ; 0334-1534
    DOI 10.1515/jbcpp-2023-0176
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  4. Article ; Online: Bispecific antibodies and its applications: a novel approach for targeting SARS-Cov-2.

    Shukla, Ajay Kumar / Misra, Saurav

    Journal of basic and clinical physiology and pharmacology

    2023  Volume 34, Issue 2, Page(s) 161–168

    Abstract: The COVID-19 pandemic remains a severe global threat, with the world engulfed in the struggle against the disease's second or third waves, which are approaching frightening proportions in terms of cases and mortality in many nations. Despite the critical ...

    Abstract The COVID-19 pandemic remains a severe global threat, with the world engulfed in the struggle against the disease's second or third waves, which are approaching frightening proportions in terms of cases and mortality in many nations. Despite the critical need for effective therapy, there is still uncertainty about the optimal practices for treating COVID-19 with various pharmaceutical approaches. This being third year, global immunity and eradication of SARS-CoV-2 is currently seems to be out of reach. Efforts to produce safe and effective vaccinations have shown promise, and progress is being made. Additional therapeutic modalities, as well as vaccine testing in children, are required for prophylaxis and treatment of high-risk individuals. As a result, neutralising antibodies and other comparable therapeutic options offer a lot of promise as immediate and direct antiviral medications. Bispecific antibodies offer a lot of potential in COVID-19 treatment because of their qualities including stability, small size and ease of manufacture. These can be used to control the virus's infection of the lungs because they are available in an inhalational form. To combat the COVID-19 pandemic, innovative approaches with effective nanobodies, high-expression yield and acceptable costs may be required.
    MeSH term(s) Child ; Humans ; SARS-CoV-2 ; COVID-19/therapy ; Antibodies, Bispecific/therapeutic use ; Pandemics/prevention & control ; COVID-19 Drug Treatment
    Chemical Substances Antibodies, Bispecific
    Language English
    Publishing date 2023-01-06
    Publishing country Germany
    Document type Journal Article ; Review
    ZDB-ID 1071737-7
    ISSN 2191-0286 ; 0792-6855 ; 0334-1534
    ISSN (online) 2191-0286
    ISSN 0792-6855 ; 0334-1534
    DOI 10.1515/jbcpp-2022-0068
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  5. Article ; Online: Teplizumab: type 1 diabetes mellitus preventable?

    Misra, Saurav / Shukla, Ajay Kumar

    European journal of clinical pharmacology

    2023  Volume 79, Issue 5, Page(s) 609–616

    Abstract: Type 1 diabetes mellitus (T1DM) is an autoimmune condition driven by T lymphocytes that specifically declines the function of beta cells of pancreas. Immunological treatments aim to stop this decline in β-cell function thus preventing TIDM. Although TIDM ...

    Abstract Type 1 diabetes mellitus (T1DM) is an autoimmune condition driven by T lymphocytes that specifically declines the function of beta cells of pancreas. Immunological treatments aim to stop this decline in β-cell function thus preventing TIDM. Although TIDM occur at any age, it is one of the most common chronic disorders in children. T1DM accounts for 5 to 10% of all cases of diabetes amounting 21-42 million affected persons. Teplizumab is a novel drug recently approved by the US FDA for the treatment of T1DM. This drug reduces abnormal glucose tolerance who are at high risk for developing T1DM and have antibodies suggesting an immunological attack on their pancreas. A 14-day infusion of the drug prevents T cells' attack of the insulin-producing cells of the pancreas. Adverse events due to teplizumab reported so far mild and of limited duration. This review gives an overview of the preclinical and clinical research on teplizumab for their role in new-onset T1DM.
    MeSH term(s) Child ; Humans ; Diabetes Mellitus, Type 1/drug therapy ; Diabetes Mellitus, Type 1/prevention & control ; Insulin ; Antibodies, Monoclonal, Humanized/therapeutic use ; Autoimmune Diseases
    Chemical Substances teplizumab (S4M959U2IJ) ; Insulin ; Antibodies, Monoclonal, Humanized
    Language English
    Publishing date 2023-04-01
    Publishing country Germany
    Document type Journal Article ; Review
    ZDB-ID 121960-1
    ISSN 1432-1041 ; 0031-6970
    ISSN (online) 1432-1041
    ISSN 0031-6970
    DOI 10.1007/s00228-023-03474-8
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  6. Article ; Online: The Use of Ivermectin in the Treatment of COVID-19.

    Shukla, Ajay Kumar / Misra, Saurav

    Journal of general internal medicine

    2023  Volume 38, Issue 6, Page(s) 1554

    MeSH term(s) Humans ; Ivermectin/therapeutic use ; COVID-19 ; Treatment Outcome ; Antiviral Agents
    Chemical Substances Ivermectin (70288-86-7) ; Antiviral Agents
    Language English
    Publishing date 2023-02-28
    Publishing country United States
    Document type Letter ; Comment
    ZDB-ID 639008-0
    ISSN 1525-1497 ; 0884-8734
    ISSN (online) 1525-1497
    ISSN 0884-8734
    DOI 10.1007/s11606-023-08104-8
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  7. Article ; Online: Trial of Metformin, Ivermectin, and Fluvoxamine for Covid-19.

    Shukla, Ajay K / Misra, Saurav

    The New England journal of medicine

    2022  Volume 387, Issue 24, Page(s) e65

    MeSH term(s) Humans ; COVID-19 ; Ivermectin/therapeutic use ; Fluvoxamine/therapeutic use ; Metformin/therapeutic use
    Chemical Substances Ivermectin (70288-86-7) ; Fluvoxamine (O4L1XPO44W) ; Metformin (9100L32L2N)
    Language English
    Publishing date 2022-12-14
    Publishing country United States
    Document type Letter ; Comment
    ZDB-ID 207154-x
    ISSN 1533-4406 ; 0028-4793
    ISSN (online) 1533-4406
    ISSN 0028-4793
    DOI 10.1056/NEJMc2212542
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  8. Article ; Online: Clinical implications of anti-idiotype antibodies in COVID-19.

    Shukla, Ajay Kumar / Misra, Saurav

    Journal of basic and clinical physiology and pharmacology

    2022  Volume 33, Issue 6, Page(s) 727–733

    Abstract: Idiotype-based therapeutics have failed to deliver their promise, necessitating rethinking of the concept and its potential to develop a viable immunotherapy method. The idiotype based hypothesis is discussed in this paper in order to produce effective ... ...

    Abstract Idiotype-based therapeutics have failed to deliver their promise, necessitating rethinking of the concept and its potential to develop a viable immunotherapy method. The idiotype based hypothesis is discussed in this paper in order to produce effective anti-idiotype vaccinations. Polyclonal anti-idiotype reagents have been shown to be more successful in animal models, and a better understanding of the immune response in humans supports the idea that polyclonal anti-idiotype vaccines will be more effective than monoclonal-based anti-idiotype vaccines. This innovative approach can be used to produce therapeutic antibodies in a Biotech-standard manner. The idiotype network has been tweaked in the lab to provide protection against a variety of microbiological diseases. Antibodies to image-idiotype antigens, both internal and non-internal, can elicit unique immune responses to antigens. The current outbreak of severe acute respiratory syndrome 2 (SARS-2) has presented a fantastic chance to use idiotype/anti-idiotype antibodies as a protective regimen, which might be used to treat COVID-19 patients. The development of various effective vaccinations has been crucial in the pandemic's management, but their effectiveness has been limited. In certain healthy people, the development of viral variations and vaccinations can be linked to rare off-target or hazardous effects, such as allergic responses, myocarditis and immune-mediated thrombosis and thrombocytopenia. Many of these occurrences are most likely immune-mediated. The current analysis reveals successful idiotype/anti-idiotype antibody uses in a variety of viral illnesses, emphazising their importance in the COVID-19 pandemic.
    MeSH term(s) Humans ; Animals ; COVID-19 ; Antibodies, Monoclonal/therapeutic use ; Pandemics/prevention & control ; Immunoglobulin Idiotypes ; Vaccines ; Antibodies, Anti-Idiotypic/therapeutic use
    Chemical Substances Antibodies, Monoclonal ; Immunoglobulin Idiotypes ; Vaccines ; Antibodies, Anti-Idiotypic
    Language English
    Publishing date 2022-10-24
    Publishing country Germany
    Document type Journal Article ; Review
    ZDB-ID 1071737-7
    ISSN 2191-0286 ; 0792-6855 ; 0334-1534
    ISSN (online) 2191-0286
    ISSN 0792-6855 ; 0334-1534
    DOI 10.1515/jbcpp-2022-0123
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    Zs.A 3207: Show issues Location:
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  9. Article ; Online: An overview of post COVID sequelae.

    Shukla, Ajay Kumar / Misra, Saurav

    Journal of basic and clinical physiology and pharmacology

    2022  Volume 33, Issue 6, Page(s) 715–726

    Abstract: After healing from COVID-19, patients often experience a slew of symptoms known as post COVID-19 sequelae. Despite the fact that the SARS-CoV-2 pandemic is still ongoing, post-Covid-19 syndrome is already a difficult problem to address: long-term ... ...

    Abstract After healing from COVID-19, patients often experience a slew of symptoms known as post COVID-19 sequelae. Despite the fact that the SARS-CoV-2 pandemic is still ongoing, post-Covid-19 syndrome is already a difficult problem to address: long-term multiorgan sequelae, while frequently described, have yet to be systematized. As a result, post-Covid-19 syndrome can have a major influence on surviving patients' working capacity as well as their personal lives. The clinical spectrum and long-term course of this clinical entity must be better understood. Post-Covid syndrome affects a wide spectrum of individuals (16-87%), with pneumological and cognitive symptoms being the most common. Pulmonary fibrosis was the most common organic consequence seen in post-Covid patients. In conclusion, post-Covid-19 syndrome can have a major impact on the health of survivors. Working-age patients should seek rehabilitation and follow-up in interdisciplinary rehabilitation programmes. Given the pandemic's global extent, it's obvious that COVID-19-related healthcare demands will continue to climb for the foreseeable future. For COVID-19 survivors' long-term mental and physical health, present outpatient infrastructure will be utilised, scalable healthcare models will be built, and cross-disciplinary collaboration will be required.
    MeSH term(s) Humans ; COVID-19/complications ; SARS-CoV-2 ; Pandemics
    Language English
    Publishing date 2022-04-15
    Publishing country Germany
    Document type Journal Article ; Review
    ZDB-ID 1071737-7
    ISSN 2191-0286 ; 0792-6855 ; 0334-1534
    ISSN (online) 2191-0286
    ISSN 0792-6855 ; 0334-1534
    DOI 10.1515/jbcpp-2022-0057
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  10. Article ; Online: Antibody-dependent enhancement of virus infection and disease: implications in COVID-19.

    Shukla, Ajay Kumar / Misra, Saurav

    Journal of basic and clinical physiology and pharmacology

    2022  Volume 33, Issue 1, Page(s) 13–16

    Abstract: Antibody-dependent enhancement (ADE) can be seen in a variety of viruses. It has a deleterious impact on antibody treatment of viral infection. This effect was first discovered in the dengue virus, and it has since been discovered in the coronavirus. ... ...

    Abstract Antibody-dependent enhancement (ADE) can be seen in a variety of viruses. It has a deleterious impact on antibody treatment of viral infection. This effect was first discovered in the dengue virus, and it has since been discovered in the coronavirus. Over 213 million people have been affected by the rapid spread of the newly emerging coronavirus, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), which causes coronavirus disease 2019 (COVID-19). The new coronavirus offers a significant threat and has sparked widespread concern. ADE in dengue virus and other viruses are discussed with possible effect on COVID-19 treatment and vaccine development will need to consider this phenomenon to ensure it is mitigated and avoided altogether. In these case scenarios, the role of ADE and its clinical consequences remains to be explored for this newly detected virus.
    MeSH term(s) Antibody-Dependent Enhancement ; COVID-19/drug therapy ; COVID-19/immunology ; Humans
    Language English
    Publishing date 2022-01-07
    Publishing country Germany
    Document type Journal Article
    ZDB-ID 1071737-7
    ISSN 2191-0286 ; 0792-6855 ; 0334-1534
    ISSN (online) 2191-0286
    ISSN 0792-6855 ; 0334-1534
    DOI 10.1515/jbcpp-2021-0264
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