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news.Intra-Cellular Therapies has announced positive preclinical data from its ongoing development programs for ITI-007, its dual 5HT2A receptor antagonist or dopamine receptor phosphoprotein modulator, and ITI-722, a low-dose formulation of ITI-007, which are in development for schizophrenia and sleep disorders, respectively.
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These new data demonstrate ITI-007 has preclinical activity both in vitro and in vivo as an antidepressant. ITI-007 acts as a potent inhibitor of the serotonin transporter (SERT), a major target for most antidepressant drugs. To examine whether this in vitro activity could be predictive of behavioral activity in vivo, the antidepressant effect of ITI-007 was investigated using an animal model of depression involving social stress.
Repeated treatment of ITI-007 improved performance in this animal model, consistent with antidepressant-like efficacy. The combined actions of ITI-007 as a SERT inhibitor, a 5HT2A receptor antagonist, and a dopamine receptor phosphoprotein modulator (DPPM) may provide a unique, antidepressant drug with a more optimal profile, including a lack of sexual side effects common to other antidepressant drugs.
Sharon Mates, chairman and CEO of Intra-Cellular Therapies, said: “These studies demonstrate ITI-007 may have antidepressant activity in addition to its potential in treating sleep maintenance insomnia and psychosis in patients.”