BLI-1008 is one of BioLite’s CNS leading projects, and it is approved by US FDA to proceed into phase II clinical trial in Jan, 2016, which is a great news for us.
Attention deficit hyperactivity disorder (ADHD) is a common psychiatric disorder affecting children and adolescents. ADHD patients usually show inattentive, hyperactive or impulsive symptoms.
These symptoms often lead to poor school performance and lack of self-control which might further affect personality, interpersonal skills, or even lead to anti-social behavior.
BLI-1008 is extracted from Traditional Chinese Medicine which widely used in Asia and Europe. In animal studies, it was revealed that BLI-1008 reduced total activity in an ADHD mouse model.
BLI-1008 has been proven safe with limited in side effects in a phase I human clinical trial on another indication and it does not reduce appetite.
As mentioned above, most ADHD patients are children, reduction of appetite might have negative effects on their growth. Our drug is proved to avoid this concern based on clinical trial.
The primary objective of this new IND trial was to determine the effective doses and treatment period of BLI-1008 in subjects with ADHD.
The secondary objective was to evaluate the safety of BLI-1008 Capsule in subjects receiving BLI-1008 at various dose levels.
