Clinical Trial News

The EMA's refusal to approve lecanemab, a drug for early Alzheimer's, contrasts with its approval in multiple countries. Critics argue the EMA overestimated risks and underestimated benefits, despite manageable side effects. The EMA's exclusion of researchers with industry ties, seen as a conflict of interest, may hinder objective assessments and slow drug approvals.

Cardiol Therapeutics completes MAvERIC Phase II study for recurrent pericarditis, showing marked reductions in pain and inflammation at 8 weeks. Full clinical data to be presented at the American Heart Association Scientific Sessions 2024.

Delta-Fly Pharma's Phase I/II trial of DFP-10917 combined with Venetoclax for AML patients received FDA approval in April 2024, with the first patient enrolled at the University of Virginia Hospital. The study aims to compare the combo-therapy's efficacy with current standard AML therapy, targeting a CR rate and PFS. Post-trial success, Delta-Fly Pharma plans to collaborate with a mega pharmaceutical company for an NDA.

Zydus Lifesciences announced successful completion of Phase II(a) trial for Usnoflast, an NLRP3 inflammasome inhibitor, in ALS patients. The trial showed Usnoflast's safety, ability to reach therapeutic levels in blood and spinal fluid, and reduction of Neurofilament Light chain levels, suggesting potential benefits for neurodegenerative conditions. Improvements in ALS Functional Rating Scale and Slow Vital Capacity scores indicate Usnoflast may slow ALS progression.

Silo Pharma completes pre-IND meeting with FDA for SPC-15, an intranasal treatment for PTSD and stress-induced anxiety, aligning on the 505(b)(2) regulatory pathway. The company plans to advance SPC-15 into human trials, aiming for FDA approval and commercialization.

KalVista Pharmaceuticals to participate in a fireside chat at the 2024 Cantor Global Healthcare Conference on September 19th. The company announced positive phase 3 data for its oral therapy, sebetralstat, in February 2024, with an FDA PDUFA goal date of June 17, 2025. KalVista received EMA MAA validation in August 2024 and plans to file for approval in the UK, Japan, and other countries later in 2024.

Dupixent showed a 31% reduction in COPD exacerbations and improved lung function in a pooled analysis of BOREAS and NOTUS phase 3 studies, reinforcing its clinical benefit for uncontrolled COPD patients with type 2 inflammation.

Serac Healthcare and University of Exeter start Phase II study on 99mTc-maraciclatide, a SPECT imaging agent for ILD prognostication. PREDICT-ILD aims to assess CT effectiveness in ILD progression detection, with a sub-study evaluating 99mTc-maraciclatide. Recruitment ongoing at three NHS sites, led by Professors Scotton and Dixon, funded by Wellcome Trust. Sub-study to compare 99mTc-maraciclatide uptake between IPF, non-IPF fibrosing-ILD, and healthy controls, aiming to predict disease progression.

AstraZeneca shares dropped 5% after disappointing lung cancer drug trial results, with its experimental drug datopotamab deruxtecan not significantly improving overall survival for patients.

TC BioPharm plans pre-clinical studies for Monkey Pox treatment with TCB 008, an unmodified cell therapy using gamma delta T cells. The company also progresses ACHIEVE Phase 2b trial for AML/MDS-AML with TCB008, and secures a European patent for modified delta cells in cancer and viral treatments.