Tag Archive for: Clinical Trial

Xeltis announces completion of enrolment in EU Pivotal Trial for aXess and prepares for market approval

Enrolment completed – 120 patients with end-stage renal disease in 22 centers in Europe Primary endpoint readouts anticipated in Q2 2025, first market approval expected in 2026 Capability to obtain market approval is further strengthened with the appointment of Rob Eyers as Chief Technology Officer. EINDHOVEN, The Netherlands, 7 January 2025 – Xeltis, a leading […]

Vesper Bio initiates Phase Ib/IIa proof of concept study of VES001 in asymptomatic patients with gene mutations that cause frontotemporal dementia (FTD)

Dosing of VES001 has commenced in patients with causal gene mutations for FTD(GRN), a type of frontotemporal dementia which is invariably fatal This follows Vesper having received clinical trial authorisation from the Netherlands and the United Kingdom to initiate its Phase Ib/IIa “SORT-IN-2” trial VES001 is a first-in-class, potentially disease-modifying, orally-dosed, brain-penetrant treatment for FTD(GRN), […]

Antag Therapeutics Announces FDA Clearance of Investigational New Drug (IND) Application for Lead Molecule, AT-7687

Copenhagen, Denmark – October 9, 2024 – Antag Therapeutics, a leading biopharmaceutical company focused on targeting the Glucose-Dependent Insulinotropic Polypeptide (GIP) receptor to pioneer novel treatments for obesity, today announced that the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application for its lead molecule, AT-7687. This milestone enables Antag […]

Weekly round-up: From a vaccine protein manufacturing collaboration, to the appointment of an orthopaedic devices expert…

MinervaX ApS, a privately held Danish biotechnology company developing a novel, prophylactic vaccine against Group B Streptococcus and Wacker Biotech, a contract development and manufacturing organisation, on Tuesday announced a collaboration to manufacture the active protein ingredients of MinervaX’s GBS vaccine. MinervaX will scale up supply of its novel GBS vaccine, ahead of commencing phase […]

Vesper Bio announces successful Phase I study for potentially disease-modifying treatment for frontotemporal dementia

VES001 is a first-in-class oral, brain penetrant, small molecule sortilin inhibitor for treatment of FTD(GRN) Data demonstrate excellent safety, tolerability profile, dose-proportionality and target engagement with elevations in progranulin in both plasma and CNS CTA filed for Phase IIa study, first dose targeted for Q4 2024 Copenhagen, Denmark, 04 September 2024 – Vesper Bio ApS […]