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news.Italian pharmaceutical company Abiogen Pharma has begun a phase II clinical trial in Vienna, Austria, evaluating its investigational drug ABIO 08/01 in the treatment of patients with generalized anxiety disorder.
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ABIO 08/01 is the first in a new class of non-addictive drugs, different from anxiolytic sedatives, and is being developed to treat clinical anxiety states such as panic disorder or generalized anxiety disorder (GAD).
The pharmacological efficacy of ABIO 08-01 was studied in several animal models of anxiety and showed that the molecule was active after a single oral administration.
Abiogen Pharma performed two previous clinical phase I studies in the University of Vienna in which ABIO 08-01 showed a good profile of safety and tolerability.
Moreover, the data dealing with EEG/ERP mapping provide evidence about peculiar CNS effects of ABIO 08/01. “Comparisons of imaging with previous data arisen from studies conducted at the same investigational centre, present a pharmacological profile of ABIO 08/01 which seems to be extremely innovative,” said the company in a statement.
Anxiety is one of the most commonly observed group of CNS disorders. This includes phobias, panic attacks, obsessive-compulsive disorders and other syndromes and shows a co-morbidity with other psychiatric or medical conditions, which complicates their course and severity. Symptoms of anxiety can significantly impair functionality and quality of life for millions of these individuals.
According to the company, generalized anxiety disorder which affects an estimated 5% of people, results in direct annual healthcare costs of approximately $1.5 billion in Europe.