Clinical Trial News

New clinical trial NCT06560229 aims to assess if monthly food support via grocery gift cards for a year reduces food insecurity and healthcare utilization in Medicaid ACO families. Participants complete surveys post-discharge, with primary outcomes including reutilization and food insecurity measures, and secondary outcomes focusing on primary care utilization and vaccine uptake. Trial details include a start date of August 19, 2024, and primary completion by July 31, 2026.

The FDA has authorized BioVie's investigational new drug application for bezisterim to treat neurological symptoms associated with post–COVID-19 condition. A phase 2 trial will evaluate bezisterim's safety, tolerability, and potential to reduce neurocognitive symptoms in 200 patients over 3 months. Bezisterim, which acts on inflammatory pathways, is also being investigated for Alzheimer Disease and Parkinson Disease.

Theolytics received a £2m grant from Innovate UK to fund a Phase I trial of THEO-260 for platinum-resistant ovarian cancer, aiming to assess safety, tolerability, and optimal dosage.

Grit Biotechnology received FDA clearance for GT201, a genetically-engineered TIL therapy for advanced solid tumors, based on StemTexp and StaViral platforms. GT201, which enhances T-cell survival and function without heavy reliance on IL-2, previously received IND clearance from China's Center for Drug Evaluation. Early data presented at ASGCT and ASCO 2023 showed stable in-vivo expansion and good safety profile. Grit is also developing GT101, a non-genetically engineered TIL product, on track for a China BLA submission in 2025.

KalVista Pharmaceuticals announced the FDA accepted its New Drug Application for sebetralstat, an oral plasma kallikrein inhibitor for on-demand treatment of hereditary angioedema (HAE) attacks in patients aged 12 and older, with a PDUFA goal date of June 17, 2025. Sebetralstat, if approved, would be the first oral on-demand treatment for HAE. The NDA was supported by data from the KONFIDENT phase 3 trial and ongoing KONFIDENT-S extension trial, showing significant symptom relief and good tolerability. KalVista also initiated the KONFIDENT-KID trial for pediatric patients aged 2-11 and expects to file for approval in the UK, Japan, and other countries in 2024.

Athira Pharma announced that its Phase 2/3 LIFT-AD trial of fosgonimeton did not meet primary or key secondary endpoints for Alzheimer's disease, but showed potential in specific subgroups and biomarker improvements.

PALIZADE is a Phase 2b, randomized, controlled, double-blind, multicenter study evaluating the efficacy and safety of zetomipzomib (KZR-616) 30 mg or 60 mg vs. placebo in patients with active lupus nephritis. Sponsored by Kezar Life Sciences, it involves screening, 52 weeks of treatment, and a follow-up visit. Participants must meet specific criteria, including age, biopsy results, and lab values, and cannot have certain medical conditions or received specific treatments. The study is placebo-controlled, double-blind, and conducted globally.

A 2x2 randomized trial comparing self-expandable vs balloon-expandable valves and general vs local anesthesia in transcatheter aortic valve replacement patients.

A new experimental drug aims to help dogs live longer by slowing aging. It's being tested in a clinical trial involving over 1,000 dogs, with half receiving the drug and half a placebo. The drug activates calorie restriction pathways without limiting food intake.

7 Hills Pharma announced their first cancer patient has been safely dosed with alintegimod, an integrin-targeted agonist. The multicenter Phase 1b/2a study is supported by awards from the Cancer Prevention and Research Institute of Texas and the National Cancer Institute. Alintegimod leverages a novel mechanism to enhance immune cell trafficking and T cell activation.