Alar Pharmaceuticals Inc (TPEx:6785), a Chinese clinical-stage pharmaceutical company developing long-acting injectables to treat central nervous system (CNS) disorders, announced on Wednesday the dosing of the first patient in the multiple ascending study of subcutaneous extended-release Ketamine (ALA-3000) for Treatment-Resistant Depression (TRD) in the United States.
This phase 1, multicentre, randomised, double-blind, placebo-controlled, multiple-dose study is intended to assess the safety, tolerability, pharmacokinetics and preliminary efficacy of ALA-3000 Injection in addition to standard of care in TRD patients.
Developed by Alar Pharmaceuticals, ALA-3000 is the first formulation of ketamine lasting over one week in the blood following single dose. The company says that it has been demonstrated in the animal model for more than one month of antidepressant effects. This innovative formulation is intended to alleviate symptoms of TRD by delivering a stable, low level of ketamine. By doing so, it seeks to reduce common side effects associated with rapid-acting ketamine formulations, such as sedation, dissociation, dizziness and anxiety.
ALA-3000 is expected to minimise the need for frequent clinic visits and prolonged on-site monitoring, Alar said.
Galderma's nemolizumab recommended for NHS funding in England and Wales for atopic dermatitis
Merck launches Phase 3 trial for dengue vaccine candidate V181
FDA grants priority review to Innoviva's zoliflodacin for treatment of gonorrhea
AB Science secures Canadian patent for AB8939, completing global IP coverage for AML treatment
Mezzion Pharma obtains USD20m funding for udenafil Phase 3 clinical development for Fontan patients
UCB announces BIMZELX (bimekizumab-bkzx) three-year data at EULAR 2025
US FDA approves expanded indication for AbbVie's MAVYRET (glecaprevir/pibrentasvir) in acute HCV
MaxCyte and Ori Biotech partner to advance autologous cell therapy manufacturing
OptiBiotix announces publication of positive SlimBiome study in European Journal of Nutrition
Crossject advances paediatric development of ZEPIZURE Junior for epilepsy crisis management
Bayer and Broad Institute extend cardiovascular research alliance to advance precision therapies