Jensen Beach

Researchers are evaluating LBP-EC01, a recombinant bacteriophage cocktail, in a Phase 2 study for treating acute uncomplicated urinary tract infections (UTIs) caused by drug-resistant E. coli. The study includes an initial open-label pharmacokinetic phase with 30 patients to find the best dosing regimen, followed by a blinded randomized phase with 288 patients comparing LBP-EC01 plus antibiotic to placebo plus antibiotic. All participants must have active acute uncomplicated UTI at the start and a history of prior UTI caused by antimicrobial-resistant E. coli. The study has two parts: Part 1 involves three different dosing regimens of LBP-EC01 combined with oral trimethoprim/sulfamethoxazole (TMP/SMX) given over three days. These regimens include intraurethral doses on Days 1 and 2 plus intravenous doses of varying amounts and infusion methods on Days 1 through 3. Part 2 is a double-blind randomized trial using the selected dosing regimen from Part 1, comparing LBP-EC01 plus antibiotic to placebo plus antibiotic, both given orally twice daily for three days. Participants will be closely monitored through urine and blood testing to measure LBP-EC01 levels and assess symptom resolution and microbiologic response by Day 10. Study visits include sample collection, adherence to medication, and safety assessments. Female participants of childbearing potential must use effective contraception during the study and for two weeks after treatment. The study also includes a six-month follow-up period to monitor outcomes and any recurrence of infection.

Researchers are evaluating whether the drug zilebesiran can reduce the risk of major cardiovascular events such as cardiovascular death, nonfatal heart attacks, strokes, or heart failure in adults who have hypertension that is not well controlled and who either have established cardiovascular disease or are at high risk for it. This Phase 3 global study is designed to continue until enough cardiovascular events have occurred to assess the treatment's effect. Participants will be randomly assigned to receive either zilebesiran or a placebo, both given as injections under the skin (subcutaneous administration). All participants will continue with their standard care, which includes treatment with at least two antihypertensive medications, one of which must be a diuretic such as a thiazide or loop diuretic. The study is double-blind, so neither participants nor researchers know who is receiving the active drug or placebo. During the study, participants will be closely monitored for cardiovascular events including heart attacks, strokes, heart failure hospitalizations, and cardiovascular deaths over approximately five years. Researchers will collect data on these events to determine the time until the first occurrence of any of these outcomes. Safety assessments and standard clinical evaluations will also be performed throughout the study period to ensure participant well-being.