Clinical Trial News

Inebilizumab, targeting CD19+ B cells, is tested in the first international, double-blind, placebo-controlled trial (MITIGATE) for preventing flares in IgG4-RD, a disease causing organ dysfunction and reduced quality of life. The trial aims to assess efficacy, safety, and impact on glucocorticoid use, with 160 participants across 22 countries.

Recent advancements in clinical trial designs for glioblastoma (GBM) are paving the way for more efficient drug discovery. This article explores the implementation of Phase 0, window of opportunity, and adaptive trials, highlighting their potential to expedite the identification of effective therapies.

RPT193, an oral CCR4 antagonist, was tested in healthy and atopic dermatitis (AD) subjects. It was well tolerated, with mild/moderate adverse events. AD subjects showed clinical improvement and skin biomarker changes, indicating RPT193's potential in treating inflammatory skin diseases.

The ORINOCO study reveals that trial teams spend three times more time collecting secondary outcome data than primary, with a median ratio of 1:3. This imbalance, consistent across trial types, suggests a need for better alignment of data collection efforts with outcome importance. Public health trials, however, show a more balanced distribution but higher overall data collection time and cost.

The FDA revoked the Emergency Use Authorization for bebtelovimab, 175mg, effective November 30, 2022. This monoclonal antibody treatment for COVID-19, including specific injection codes and administration details, was authorized from August 15, 2022, to November 30, 2022.

Lecanemab 10 mg/kg biweekly showed dose-dependent reductions in brain amyloid, improved plasma biomarkers, and slowed cognitive decline in Alzheimer's patients. Treatment differences vs placebo were maintained over 24 months, with amyloid PET and plasma biomarkers indicating sustained effects. The study supports lecanemab's potential for disease modification in early AD stages.

Eagle Pharmaceuticals' PEMFEXY® received FDA approval for treating metastatic, non-squamous NSCLC without EGFR or ALK aberrations, marking its fifth indication. PEMFEXY, a ready-to-use liquid, eliminates reconstitution, offering advantages over ALIMTA®. Eagle amended its agreement to reduce future royalties, aiming to capture PEMFEXY's commercial potential.

Vergent Bioscience completed patient enrollment for its Phase 2 VISUALIZE trial, testing abenacianine for injection (VGT-309) in lung cancer surgery. The trial aims to improve tumor visibility during minimally invasive surgeries, with 89 patients enrolled across the U.S. and Australia. Positive results could lead to a Phase 3 study and a new drug application.

The FDA has approved nadofaragene firadenovec-vncg (Adstiladrin) as the first gene therapy for adult patients with high-risk Bacillus Calmette-Guérin (BCG)–unresponsive non–muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), offering a new treatment option beyond bladder removal surgery.

RenovoRx, Inc. has announced the acceptance of four clinical data abstracts supporting its lead oncology product candidate, RenovoGem, and its proprietary RenovoTAMP therapy platform at the 2023 ASCO Gastrointestinal Cancers Symposium. These abstracts highlight the innovative approach to treating difficult-to-treat cancers, with a focus on locally advanced pancreatic cancer and extrahepatic cholangiocarcinoma.