Clinical Trial News

PTG-007 Treg cell therapy showed clinical remission in type-1 diabetes patients for up to 12 years, with some remaining insulin-independent for 24 months. The therapy is set to enter a pivotal study, with data presented at the INNODIA EASD conference.

Eisai and Biogen's Leqembi and Eli Lilly's Kisunla are first anti-amyloid antibodies to slow Alzheimer's cognitive decline. 32 therapeutics in Phase III trials target neuroprotection, neurotransmitters, neurogenesis, inflammation, and proteinopathies. Leqembi and Kisunla have limited efficacy and notable side effects, prompting diverse opinions on clinical benefit. Next-gen therapeutics aim for easier administration and multiple pathways to treat Alzheimer's.

MDA launches Kickstart program for ultra-rare neuromuscular disease drug development, collaborating with UC Davis and Forge Biologics. Focusing on gene therapy for Congenital Myasthenic Syndrome (CMS) caused by CHAT gene mutations, the program aims to bridge the gap between early science and FDA approval, leveraging Forge's AAV manufacturing services. MDA seeks Rare Pediatric Disease Priority Review Voucher reauthorization to support these efforts.

Healios KK (JP:4593) has agreed with the FDA to conduct a global Phase 3 trial, REVIVE-ARDS, assessing MultiStem therapy for ARDS, with Ventilator Free Days as the primary endpoint. The trial will include interim analyses at 300 and 400 patients, up to a maximum of 550 patients. Healios aims to discuss conditional approval in Japan based on Phase 2 results and the upcoming study.

BR-6002, developed by Boryung Pharmaceutical, targets cardiovascular disease, gastric ulcers, and duodenal ulcers via oral administration. Boryung specializes in chronic disease treatments, including hypertension, dyslipidemia, and cancers. GlobalData's analytics assess drug-specific Phase Transition and Likelihood of Approval (PTSR and LoA) scores based on historical data and proprietary algorithms.

Pidnarulex (CX-5461) showed acceptable tolerability and preliminary efficacy in Phase Ib study, with 40% of evaluable end-stage oncology patients achieving clinical benefit, including stable disease (SD) in those previously resistant to PARP inhibitors.

HUTCHMED announces new data from studies of compounds to be presented at 2024 WCLC and ESMO Congresses. Key findings include positive results from the FLOWERS study, showing deeper and more durable response with osimertinib plus savolitinib in EGFRm, MET-aberrant advanced NSCLC patients compared to osimertinib monotherapy.

Antennova to present ATN-037 data at ESMO Congress 2024, showing 43.8% DCR in monotherapy and 65.0% DCR in combination therapy.

Natera to present new Signatera MRD test data at 2024 ESMO Congress, including updated CIRCULATE-Japan GALAXY trial results showing significant OS advantage for Signatera-negative CRC patients.

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