Publications by authors named "D P McHale"

Background: Bacterial infection of the intervertebral disc is difficult to treat because the tissue is usually not vascularized and systemic antibiotic therapy may not reach optimal antibacterial exposure. Here we characterize the safety, tolerability, and pharmacokinetics of PP353, a suspension of micronized linezolid, formulated for direct intervertebral disc administration.

Methods: The safety, tolerability, and pharmacokinetics of an intradiscal administration of PP353, was assessed in Part A of a Phase 1b study and consisted of a single injection of study drug (3 mL of PP353 and 150 mg linezolid).

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This study analyzed electronic health record (EHR) data from 2016 through 2019 from a federally qualified health center (FQHC) serving predominantly low-income Latine immigrants in the Washington, D.C. metropolitan area to examine how changes in health insurance coverage relate to changes in health care use.

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Background: Psoriasis is a chronic inflammatory skin disease. EDP1815 is an oral, gut-restricted preparation of non-live , the first of a new immunomodulatory therapeutic class targeting the small intestine to generate systemic anti-inflammatory responses.

Objective: To evaluate safety and efficacy of EDP1815 in mild-to-moderate psoriasis in a proof-of-concept study.

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The gut microbiome can modulate systemic inflammation and is therefore target for immunomodulation. Immunomodulating effects of EDP1815, a bacterial commensal strain of Prevotella histicola, were studied in healthy participants. Effects on adaptive immunity were evaluated by a neo-antigen challenge with keyhole limpet haemocyanin (KLH), while effects on innate immunity were evaluated by topical toll-like receptor 7 (TLR7) agonist imiquimod.

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Article Synopsis
  • EDP1815 is a pharmaceutical preparation derived from a single strain of bacteria isolated from a human donor's duodenum, shown to regulate inflammatory responses throughout the body in both preclinical and clinical studies.
  • Preclinical tests demonstrated that EDP1815 effectively reduced inflammation in mouse models, while clinical Phase 1b studies indicated it was well tolerated with minimal side effects in patients with psoriasis and atopic dermatitis, showing improvements after treatment.
  • The findings suggest that EDP1815 can act as a new type of medicine targeting peripheral inflammation without affecting the overall gut microbiota or causing systemic exposure, providing a promising proof of concept for future therapies.
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