drug exposure News
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Onapristone Extended Release: Safety Evaluation from Phase I–II Studies with an Emphasis on Hepatotoxicity
Introduction Anliprogestins have demonstrated promising activity against breast and gynecological cancers, but liver-related safety concerns limited the advancement of this therapeutic class. Onapristone is a full progesterone receptor antagonist originally developed as an oral contraceptive and later evaluated in phase II studies for metastatic breast cancer. Because of liver enzyme elevations ...
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An Investigator Initiated Clinical Trial of Inhaled Bofutrelvir for Post-Exposure Prophylaxis in Close Contacts of COVID-19 Patients
Shanghai Ruijin Hospital recently announced that it has initiated an investigator-initiated clinical trial (IIT) to evaluate the safety and efficacy of Bofutrelvir administered by inhalation for post-exposure prophylaxis in close contacts of COVID-19 (NCT05415241). It is a single-arm, open-label, multi-dose exploratory clinical study with an enrolment of ~60 subjects who are close contacts of ...
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Starton Therapeutics Reports Positive Results from Phase 1 Study Evaluating STAR-LLD, Continuous Delivery Lenalidomide
Starton Therapeutics Inc., (the “Company”) a clinical stage biotechnology company announced today positive results from high-level data from its Phase 1 study of STAR-LLD, evaluating the pharmacokinetics (PK) and safety of the Company’s continuous delivery lenalidomide program. The Phase 1 study met all of its primary and secondary endpoints; in all subjects dosed with ...
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UA College of Pharmacy researchers link liver disease and drug metabolism
Researchers at the University of Arizona College of Pharmacy have discovered that nonalcoholic steatohepatitis (NASH), an increasingly common but often undiagnosed liver disease, could have significant medical implications for people with type 2 diabetes. People develop NASH when early liver disease, characterized by too much fat in the liver, is exacerbated by inflammation. Obesity, which is on ...
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Cyclerion Therapeutics and Ariana Pharma Announce an Artificial Intelligence-driven Precision Medicine Collaboration
Cyclerion Therapeutics, Inc. (Nasdaq: CYCN) and Ariana Pharma (Cambridge, MA and Paris, France) today announced an artificial intelligence-driven, precision medicine collaboration. This collaboration is expected to identify biomarkers of response to refine patient selection to guide and accelerate the clinical development of Cyclerion’s investigational therapeutics for neurological and ...
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Parents concerned kids will bring home more than homework this school year
Those lazy, hazy, crazy days of summer will soon be a distant memory as parents and kids prepare to open a new chapter of the school year -- but not without fret. According to a new survey commissioned by Seventh Generation, the nation"s leading brand of environmentally responsible household and personal care products, half of all parents surveyed expressed more concern for the spread of germs ...
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Axial Therapeutics’ Scientific Founder Sarkis Mazmanian, Ph.D., to Present Research Highlighting the Gut-Brain Connection in Autism Spectrum Disorder (ASD) at TACA’s Autism Action Conference
Axial Therapeutics, a clinical-stage biopharmaceutical company dedicated to improving the lives of people with neurological disorders and conditions, today announced that its scientific founder and California Institute of Technology (Caltech) Professor, Sarkis Mazmanian, Ph.D., will be presenting at TACA’s Autism Action Conference, taking place virtually from April 8-9, 2022. The ...
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Axial Therapeutics Raises $37.25 Million in Series C Financing to Advance its Pipeline of Gut-Targeted Small Molecule Drugs for Neurological Diseases and Disorders
Proceeds will support Axial's randomized, controlled Phase 2b clinical trial for lead candidate, AB-2004, a molecular therapeutic to treat irritability in children with autism Funding positions company for platform and pipeline growth Completion of new round brings total investment in company to $91.5 million to date Axial Therapeutics, a clinical-stage biopharmaceutical company dedicated ...
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Axial Therapeutics Receives FDA Clearance of IND Application and Initiates Phase 2b Trial for AB-2004, Lead Gut-Targeted, Molecular Therapeutic for the Treatment of Irritability in Autism Spectrum Disorder
Global, placebo-controlled Phase 2b trial now enrolling in the U.S., Australia and New Zealand Axial is activating 20 Phase 2b clinical trial sites in the U.S. and seven clinical sites in Australia and New Zealand Clinical studies to date confirm AB-2004’s strong safety profile and potential to address large unmet treatment need in irritability associated with autism spectrum disorder ...
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Axial Therapeutics Doses First Subjects in Global Phase 2b Clinical Trial for Irritability Associated with Autism Spectrum Disorder (ASD)
Advancement of first program from Axial platform into a randomized Phase 2b clinical trial signifies key milestone for company Trial is enrolling approximately 195 autistic adolescents at clinical trial sites in the United States, Australia and New Zealand Phase 2 trial is based on positive results from open-label Phase 1b/2a trial that demonstrated a favorable safety profile for AB-2004 as ...
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Nature Medicine Publishes Full Results from Axial Therapeutics’ Phase 1b/2a Clinical Trial in Autism Spectrum Disorder (ASD)
Open-label study showed Axial’s Lead Candidate, AB-2004, is safe and well-tolerated in an adolescent ASD cohort AB-2004 lowered blood and urinary levels of gut-derived metabolites and significantly improved irritability and anxiety Research supports company’s clinical development strategy focused on gut-targeted therapeutics for managing irritability associated with autism ...
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