Clinical Trial News

Innovent Biologics announces mazdutide clinical study results to be presented at EASD 60th Annual Meeting in Madrid, including Phase 3 DREAMS-2 study in type 2 diabetes. Mazdutide, a GLP-1R/GCGR dual agonist, shows superior blood sugar-lowering and weight loss efficacy. Innovent has two NDAs accepted by China's NMPA for review and five ongoing Phase 3 studies.

From April 2019 to August 2023, 15 patients with various cancers and confirmed germline or somatic POL-MUTs were enrolled. Median age was 50 years, with most diagnosed at stage IV and having undergone multiple prior treatments. Most (66.7%) had POLE mutation. Response to toripalimab was evaluated in 14 patients, showing an objective response rate of 21.4% and disease control rate of 57.1%. Three patients had complete or partial responses, and two completed two-year protocol treatment. Treatment-related adverse events were reported in 60% of patients, with one death related to treatment. POLE/POLD1 mutation status influenced treatment response, with POLE-EDMs showing better response rates than POLE-non-EDMs. Patients with POLE/POLD1 and PBRM1 co-mutations exhibited higher TMB and immunotherapy response signature scores, suggesting a favorable response to immunotherapy.

Dr. Deborah Belfort presented CATHEDRAL-HF trial findings at ESC, showing discontinuation of HF treatment while maintaining carvedilol could be safe in HF with improved EF. Key opinion leaders highlighted suboptimal medication doses in chronic HF patients, and HF is a lifelong condition with various acute causes.

Schwippel et al. report on the first application of individualized closed loop tACS for depression, showing a reduction in alpha frequency brain activity and mood improvement. This technique, with its reduced safety risks and costs, has broader translational potential. Future research should address parameter optimization and safety concerns.

TEER and surgery showed no difference in efficacy for secondary mitral regurgitation (MR) in the MATTERHORN trial, with non-inferiority confirmed. Both methods effectively improved MR, though TEER had safety benefits, with fewer major complications.

No increase in complications with normal eating before cardiac catheterisation procedures under sedation; higher patient satisfaction without fasting; supports reconsidering fasting guidelines.

In patients with coronary drug-eluting stents undergoing non-cardiac surgery, aspirin monotherapy showed no difference in ischemic outcomes or major bleeding compared to no antiplatelet therapy. The ASSURE DES trial, involving 926 patients, found similar rates of primary outcomes and major bleeding, with a slight increase in minor bleeding in the aspirin group. The low event rate suggests a need for further research in higher-risk scenarios.

GUARD-AF trial, using iRhythm's Zio® XT patch for AF screening, showed a 5.0% new AF diagnosis rate vs 3.3% in usual care, with no significant difference in stroke hospitalization due to low event rates and early trial stoppage.

A fentanyl vaccine developed by University of Houston researchers is expected to enter clinical trials mid-next year, aiming to prevent the opioid from entering the brain and causing overdose. The vaccine, successful in animal studies, is licensed to Ovax, which raised over $10 million for its production and testing. Despite challenges, including lengthy clinical trial processes and stigma around addiction, the vaccine is seen as a potential tool in the fight against the opioid crisis.

Finerenone, a mineralocorticoid receptor antagonist, showed reduced heart failure exacerbations and cardiovascular deaths in patients with ejection fractions >40%, per the FINEARTS study presented at the 2024 ESC Congress.