After Lariat LAA Ligater Disappoints in aMAZE, is a Path Ahead Still Possible?
Adjunctive left atrial appendage (LAA) ligation failed to increase the efficacy of catheter pulmonary vein isolation (PVI) in the aMAZE trial, though it appeared safe enough for further clinical investigation. In a population of people with nonparoxysmal atrial fibrillation (Afib), LAA ligation plus PVI was associated with no better primary effectiveness by 12 months — […]
Novel Hepatitis E Vaccine Protects for at Least a Decade
A three-dose vaccine regimen prevented hepatitis E virus (HEV) infections with high efficacy in adults over the course of 10 years, a phase III trial from China found. The HEV239 vaccine, sold under the name Hecolin outside the U.S., had an efficacy rate of 83.1% (95% CI 69.4-91.4) in the study’s modified intention-to-treat analysis and […]
‘End of This Phase’: Trial Halts Testing of HIV Vaccine Candidates
The PrEPVacc trial has stopped administering two investigational HIV vaccines that showed no efficacy in preventing infection, investigators announced on Wednesday during the International Conference on AIDS and STIs in Africa in Zimbabwe. “Vaccinations to PrEPVacc trial participants have been stopped because an analysis of the data collected so far by our Independent Data Monitoring […]
RSV Vaccine Maintains Efficacy Across Two Seasons in Seniors
BOSTON — Efficacy of GSK’s respiratory syncytial virus (RSV) vaccine held strong through two RSV seasons in adults 60 and over, according to new results from the company’s pivotal trial. With a single dose, efficacy of the RSV perfusion F protein vaccine (Arexvy) against RSV-related lower respiratory tract disease declined from 82.6% during the first […]
FDA Mulling Trial Design Issues for Long-Term Opioids in Chronic Pain
To evaluate the long-term efficacy and tolerability of a representative extended-release (ER)/long-acting (LA) opioid in a 12-month placebo-controlled trial, FDA staff are considering an enriched enrollment randomized withdrawal (EERW) study design, they noted in a briefing document ahead of an advisory committee meeting. On Wednesday, the Anesthetic and Analgesic Drug Products Advisory Committee will consider […]
Tongue Nerve Stimulator Does Good for Sleep Apnea Patients
Targeted hypoglossal nerve stimulation (THN) showed safety and efficacy for patients with moderate-to-severe obstructive sleep apnea (OSA), the randomized THN3 trial found. Four months after receiving a THN device, patients who had had their devices activated at month 1 were more likely to meet criteria for treatment response in terms of reduced apnea-hypopnea index (AHI; […]
CEND-1 Offers Hope in Advanced Pancreatic Cancer
Chemotherapy combined with the CEND-1 cyclic peptide showed promising efficacy, and was well tolerated as a first-line treatment, for patients with metastatic pancreatic cancer, researchers reported. In a phase I study of 29 patients evaluable for efficacy, 59% (95% CI 39-77) responded to the combination of CEND-1 — a novel 9-amino acid cyclic peptide that […]
Brepocitinib Shows Promise in Phase II Trial for PsA
The oral tyrosine kinase 2/Janus kinase 1 inhibitor brepocitinib showed efficacy for psoriatic arthritis (PsA) in a phase IIb trial. At week 16, a 20% improvement on the criteria of the American College of Rheumatology (ACR20) was observed in 66.7% of patients receiving 30 mg brepocitinib daily as did 74.6% of those given 60 mg […]
Targeting IL-23 Succeeds in Psoriatic Arthritis
The monoclonal antibody risankizumab (Skyrizi) showed significant efficacy for psoriatic arthritis (PsA) in two phase III randomized trials, a researcher reported. In the KEEPSAKE 1 and 2 trials, 1,407 patients with active PsA were randomly assigned to receive subcutaneous risankizumab, 150 mg, or placebo at baseline and then at weeks 4 and 16. On the […]
Fauci: ‘Dramatic Data’ From Israel Support COVID-19 Boosters
WASHINGTON — COVID booster shots are showing good efficacy in Israel, Anthony Fauci, MD, chief medical advisor to President Biden, said Thursday at a briefing held by the White House COVID-19 Response Team. Researchers have found that, even with the country’s very high vaccination rate, “we see new PCR-positive infections and new severe COVID cases […]