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.
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