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BCI-540 Features

  • A mechanism-of-action distinct from any marketed anti-depressant.
  • Acts as a neurogenic agent directly on in vitro human neural stem cells (NSCs), unlike an SSRI which acts by an indirect mechanism.
  • In vivo neurogenesis properties similar to an SSRI.
  • Predicted to be a potent antidepressant and anxiolytic agent.
  • Well tolerated in more than 900 subjects in Phase I and II clinical trials.
 

BCI-540

BrainCells has repositioned this compound for the treatment of depression and anxiety, based on results from our proprietary neurogenesis platform technology.

Favorable Profile

BrainCells identified and selected BCI-540 to develop because of its favorable neurogenic profile similar to antidepressants available on the market today. In addition, BCI-540 appears to act as an AMPA potentiator as well as enhance choline uptake, providing a unique profile that may be optimal for the treatment of both depression and anxiety – an area with a strong market need.

Because it benefits from a novel mechanism that does not act on serotonin or norepinephrine receptors, BCI-540 has the potential to treat unresponsive and partially responsive patients with depression, especially in those patients that present with concomitant anxiety. In addition, getting away from the SSRIs and SNRIs may help further differentiate this drug with potential improvements in safety and tolerability.

Repositioned in a Different Indication

BrainCells in-licensed BCI-540 from Mitsubishi Pharmaceutical Corporation in August 2006 and is currently developing it for the treatment of patients with Major Depressive Disorder (MDD) and anxiety. Mitsubishi Pharma had previously developed the compound extensively in a CNS indication, then suspended the program when the drug met safety expectations but did not reach the defined efficacy endpoints. BrainCells has repositioned the drug and is exploring it in a Phase IIa study in depression with anxiety.