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Drug Exposure Articles & Analysis

11 news found

Starton Therapeutics Reports Positive Results from Phase 1 Study Evaluating STAR-LLD, Continuous Delivery Lenalidomide

Starton Therapeutics Reports Positive Results from Phase 1 Study Evaluating STAR-LLD, Continuous Delivery Lenalidomide

Lenalidomide has been an effective immunomodulatory drug in hematologic malignancies for years, however adverse events, notably neutropenia, have limited its use in certain patient settings. ...

ByStarton Therapeutics


An Investigator Initiated Clinical Trial of Inhaled Bofutrelvir for Post-Exposure Prophylaxis in Close Contacts of COVID-19 Patients

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 ...

ByFrontier Biotechnologies Inc.


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’ 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 believes this gut-targeted approach minimizes the potential for side effects in part due to a lack of systemic exposure to the drug. About The TAPESTRY Study Axial is evaluating AB-2004 in the TAPESTRY study, a global, randomized, double-blind, placebo-controlled Phase 2b clinical trial to assess the efficacy, safety, and tolerability of the ...

ByAxial Therapeutics Inc.


Cyclerion Therapeutics and Ariana Pharma Announce an Artificial Intelligence-driven Precision Medicine Collaboration

Cyclerion Therapeutics and Ariana Pharma Announce an Artificial Intelligence-driven Precision Medicine Collaboration

Results from initial CY6463 clinical studies have demonstrated favorable safety and tolerability and pharmacologically relevant drug exposure in the cerebral spinal fluid. Furthermore, promising impacts on EEG measures, neuroinflammation, and other measures support the current clinical development of CY6463. ...

ByAriana Pharma


Nature Medicine Publishes Full Results from Axial Therapeutics’ Phase 1b/2a Clinical Trial in Autism Spectrum Disorder (ASD)

Nature Medicine Publishes Full Results from Axial Therapeutics’ Phase 1b/2a Clinical Trial in Autism Spectrum Disorder (ASD)

Key findings from the Phase 1b/2a trial include: AB-2004 was shown to have strong safety and tolerability across all dose levels, and no drug-related serious adverse events were identified. AB-2004 showed target engagement as measured by significantly reduced levels of key gut bacterial metabolites, including 4-ethylphenyl sulfate (4EPS), in both urine and plasma. ...

ByAxial Therapeutics Inc.


Axial Therapeutics Doses First Subjects in Global Phase 2b Clinical Trial for Irritability Associated with Autism Spectrum Disorder (ASD)

Axial Therapeutics Doses First Subjects in Global Phase 2b Clinical Trial for Irritability Associated with Autism Spectrum Disorder (ASD)

Axial’s gut-targeted approach minimizes the potential for side effects due to a lack of systemic exposure to the drug. Axial is evaluating AB-2004 in a Phase 2b clinical trial based upon a large body of existing human safety data. In a Phase 1b/2a clinical trial, AB-2004 was safe and well-tolerated, exhibiting no drug-related serious ...

ByAxial Therapeutics Inc.


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

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

Axial’s gut-targeted approach minimizes the potential for side effects due to a lack of systemic exposure to the drug. Axial is evaluating AB-2004 in a Phase 2b clinical trial based upon a large body of existing human safety data. In a Phase 1b/2a clinical trial, AB-2004 was safe and well-tolerated, exhibiting no drug-related serious ...

ByAxial Therapeutics Inc.


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

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

In addition, the funds will be used to drive forward the company’s drug discovery programs based on the company’s platform in the microbiome gut-brain axis. ...

ByAxial Therapeutics Inc.


Onapristone Extended Release: Safety Evaluation from Phase I–II Studies with an Emphasis on Hepatotoxicity

Onapristone Extended Release: Safety Evaluation from Phase I–II Studies with an Emphasis on Hepatotoxicity

Evaluation of antiprogestin pharmacology and pharmacokinetic data suggested that liver enzyme elevations might be related to off-target or metabolic effects associated with clinical drug exposure. Objective We explored whether the use of a pharmaceutic strategy targeting efficacious systemic dose concentrations, but with diminished peak serum concentrations ...

ByContext Therapeutics Inc.


UA College of Pharmacy researchers link liver disease and drug metabolism

“This study, in addition to several of our other recent studies,” Clarke says, “shows that NASH, either alone or in combination with genetic differences in drug transporters, can have a profound effect on drug exposure.” Cherrington notes that this study is about the mechanism explaining how NASH changes the body’s ...

ByNational Institute of Environmental Health Sciences (NIEHS)


Parents concerned kids will bring home more than homework this school year

Parents concerned kids will bring home more than homework this school year

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 (51 percent) than exposure to drugs/alcohol (28 percent) and poor grades (45 percent). The Seventh Generation Back to School ...

ByCSRwire - Corporate Social Responsibility Newswire

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