Karim Azer

The Advancing the Development of Pediatric Therapeutics 8 (ADEPT 8) Workshop on Drug Dosing in Pediatric Patients with Renal Impairment

Shamir Tuchman, Yeruk Mulugeta, George J. Schwartz, Guido Filler et autres

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Unlocking the Mysteries of Rare Disease Drug Development: A Beginner's Guide for Clinical Pharmacologists

Mariam A. Ahmed, Bilal Abuasal, Jeffrey S. Barrett, Karim Azer et autres

Clinical pharmacologists face unique challenges when developing drugs for rare diseases. These conditions are characterized by small patient populations, diverse disease progression patterns, and a limited understanding of underlying pathophysiology. This tutorial serves as a comprehensive guide, offering practical insights and strategies …

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1H and 31P MR Spectroscopy to Assess Muscle Mitochondrial Dysfunction in Long COVID

Lucy Finnigan, Mark Philip Cassar, Mehrsa Jafarpour, Antonella Sultana et autres

MR spectroscopy showed altered phosphocreatine recovery and mitochondrial capacity in participants with post–COVID-19 condition, also called long COVID, compared with controls, suggesting mitochondrial dysfunction; however, these changes did not correlate with fatigue severity.

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Advancing precision medicine therapeutics for Parkinson’s utilizing a shared quantitative systems pharmacology model and framework

Christopher Denaro, Diane Stephenson, Martijn L.T.M. Müller, Benedetto Piccoli et autres

A rich pipeline of therapeutic candidates is advancing for Parkinson's disease, many of which are targeting the underlying pathophysiology of disease. Emerging evidence grounded in novel genetics and biomarker discoveries is illuminating the true promise of precision medicine-based therapeutic strategies for PD. …

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A minimal PBPK model to accelerate preclinical development of drugs against tuberculosis

Federico Reali, Anna Fochesato, Chanchala Kaddi, Roberto Visintainer et autres

Introduction: Understanding drug exposure at disease target sites is pivotal to profiling new drug candidates in terms of tolerability and efficacy. Such quantification is particularly tedious for anti-tuberculosis (TB) compounds as the heterogeneous pulmonary microenvironment due to the infection may alter lung …

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Insights Into Long COVID Fatigue Biology: Potential Treatment Implications Using Multi-Targeted Action of AXA1125, a Novel Endogenous Metabolic Modulator Composition

Karim Azer, Matthew W. Russell, Revati Wani, Joël Pradines et autres

With ongoing global research efforts to tackle coronavirus disease 2019 (COVID-19), increasing attention is directed toward the long-term sequelae of COVID, entitled “long COVID” or post-acute sequelae of COVID-19. These long-COVID symptoms persist beyond 12 weeks in over 10%–40% of patients, with …

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Systems biology platform for efficient development and translation of multitargeted therapeutics

Karim Azer, Irina A. Leaf

Failure to achieve efficacy is among the top, if not the most common reason for clinical trial failures. While there may be many underlying contributors to these failures, selecting the right mechanistic hypothesis, the right dose, or the right patient population are …

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Opportunities for Systems Biology and Quantitative Systems Pharmacology to Address Knowledge Gaps for Drug Development in Pregnancy

Jeffrey S. Barrett, Karim Azer

Pregnant women are still viewed as therapeutic orphans to the extent that they are avoided as participants in mainstream clinical trials and not considered a priority for targeted drug research despite the fact that many clinical conditions exist during pregnancy for which …

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Efficacy and Tolerability of AXA1125, an Endogenous Metabolic Modulator Composition, in Fatigue-predominant Long COVID: A Randomized, Double-blind, Placebo-controlled Study

Lucy Finnigan, Mark Philip Cassar, Margaret James Koziel, Karim Azer et autres

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Efficacy and tolerability of an endogenous metabolic modulator (AXA1125) in fatigue-predominant long COVID: a single-centre, double-blind, randomised controlled phase 2a pilot study

Lucy Finnigan, Mark Philip Cassar, Margaret James Koziel, Joël Pradines et autres

Background ‘Long COVID' describes persistent symptoms, commonly fatigue, lasting beyond 12 weeks following SARS-CoV-2 infection. Potential causes include reduced mitochondrial function and cellular bioenergetics. AXA1125 has previously increased β-oxidation and improved bioenergetics in preclinical models along with certain clinical conditions, and therefore …

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A pipeline for testing drug mechanism of action and combination therapies: From microarray data to simulations via Linear-In-Flux-Expressions

Christopher Denaro, Nathaniel J. Merrill, Sean T. McQuade, Logan Reed et autres

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ABNORMAL SKELETAL METABOLISM BUT NOT CARDIAC DYSFUNCTION AS A CAUSE FOR FATIGUE POST COVID-19

Mark Philip Cassar, Lucy Finnigan, Zakariye Ashkir, Margaret James Koziel et autres

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