Clinical Trial News

The FDA has granted orphan drug designation to ezurpimtrostat (GNS561), a PPT-1 inhibitor, for treating hepatocellular carcinoma (HCC), highlighting its potential to improve patient outcomes. Genoscience Pharma has initiated a phase 2b clinical trial combining ezurpimtrostat with standard treatments, aiming to share results by 2024.

Immutep Limited announced the INSIGHT-003 trial enrolled 20 patients with 1L NSCLC, testing efti in a triple therapy with anti-PD-1 and chemotherapy. Initial results show a 72.7% response rate and 90.9% disease control rate, with more data expected in 2023.

A comprehensive review of 52 studies on ocrelizumab's effectiveness in treating multiple sclerosis (MS) reveals promising real-world outcomes, including low relapse rates, significant reductions in annualized relapse rates (ARR), and improvements in magnetic resonance imaging (MRI) activity. The studies, spanning various geographical regions, indicate that ocrelizumab is effective across diverse patient populations, with outcomes consistent with those reported in pivotal clinical trials.

A retrospective analysis of 105 heavily pretreated multiple myeloma patients at The Mount Sinai Hospital showed that panobinostat-based combinations yielded modest response rates and were well-tolerated, despite the drug's withdrawal from the US market.

GSK's anemia pill, Jesduvroq, approved by US FDA for chronic kidney disease patients on dialysis, limiting its market and revenue potential. GSK shares increased by up to 1.2% in London.

Viva's portfolio companies have made notable progress in biopharmaceutical innovation, including funding achievements, clinical trial advancements, and strategic collaborations aimed at developing novel therapies for various diseases.

Rise Therapeutics received FDA clearance for its IND application to start a Phase 1 trial of R-3750, an oral immunotherapy for ulcerative colitis. R-3750 targets gut inflammation using a synthetic biology approach, aiming to treat IBD by engaging dendritic cells. The trial will assess safety, tolerability, and clinical activity in 36 participants.

Palbociclib plus ET showed a median PFS of 12.2 months in HR+/HER2- MBC patients, with a DCR of 90.5%. Earlier Palbociclib initiation is supported, showing benefits across treatment lines. Differences in outcomes may stem from patient demographics and prior treatments. Real-world data from China adds valuable insights, despite limitations.

FDA prioritizes sunvozertinib review for EGFR+ NSCLC treatment, citing WU-KONG1 trial's efficacy and safety data.

Alleviant Medical, Inc. secured $75M in equity financing led by S3 Ventures and RiverVest Venture Partners to fund the ALLAY-HF trial, testing the Alleviant System's safety and efficacy for heart failure treatment without implants. The trial aims to improve life quality for chronic heart failure patients globally.