Date: 2015-09-21
Type of information: Initiation of development program
phase: 1
Announcement:
Company: Intra-Cellular Therapies (USA - NY)
Product: ITI-214
Action
mechanism: phosphodiesterase 1 inhibitor. ITI-214 is a novel, orally available, phosphodiesterase 1 (PDE1) inhibitor being developed for the treatment of cognitive deficits in neuropsychiatric and neurological diseases. Based on preclinical studies, ITI-214 may also have the potential to treat cardiac and vascular hypertrophy associated with diseases such as congestive heart failure and may also possess anti-inflammatory activity for use in treating neuro-inflammation and other major inflammatory diseases.
Disease:
Therapeutic area: CNS diseases - Mental diseases
Country:
Trial
details:
Latest
news: * On September 21, 2015, Intra-Cellular Therapies, a biopharmaceutical company focused on the development of therapeutics for central nervous system (CNS) disorders, announced that it is assuming sponsorship of the Investigational New Drug Application (IND) for studies related to ITI-214. ITI-214 is a novel, potent phosphodiesterase type 1 (PDE1) inhibitor. Multiple human clinical Phase 1 studies have been completed. In these studies, ITI-214 demonstrated a favorable safety profile and was generally well-tolerated across a broad range of doses both in healthy volunteers and in patients with schizophrenia with a pharmacokinetic profile that supports once daily dosing. Under a license agreement, Takeda conducted four Phase 1 studies. A single rising dose study was conducted in the US in healthy male and female, Japanese and non-Japanese volunteers. In a second US study ITI-214 was administered once daily over 14 days to healthy volunteers and patients with stable schizophrenia. In a third study, conducted in Japan, ITI-214 was administered for 7 days at multiple rising oral doses in both male and female healthy volunteers. A fourth study compared the relative bioavailability of oral formulations of ITI-214 used in all previous studies to an immediate-release tablet, either with or without food in healthy volunteers. The Company is currently evaluating ITI-214 for several indications including cognition in patients with Parkinson\'s disease, dementia, schizophrenia and other CNS and non-CNS disorders.
