Intra-Cellular pulls off $150M funding as it preps schizophrenia drug filing

Dollar bills falling
Cash will fund pre-launch and commercial activities for lumateperone.

Intra-Cellular Therapies raised its target of $150 million from a new public offering that will help it prepare for an FDA filing for lead drug lumateperone in schizophrenia next year.

The New York City biotech will net $141 million from the fundraising, which could rise to around $160 million if underwriters take up a 30-day option on another block of shares.

According to the offer prospectus, ICT intends to use the cash to fund pre-launch and commercial activities for lumateperone (also known as ITI-007) in schizophrenia, as well as to bring forward other potential indications such as bipolar disorder and behavioral disturbances in dementia, which are in late-stage testing.

It will also help fund other pipeline prospects including a long-acting formulation of lumateperone due to start trials next year, and PDE1-targeting compounds for Parkinson’s disease and other central nervous system disorders.

The new funding comes at a pivotal point for ICT, which has been in discussions with the FDA for several months trying to work out whether its portfolio of lumateperone studies will be enough to support a filing, while gathering evidence to alleviate concerns about its safety profile.

In August, the biotech said it had provided evidence to the FDA that safety issues seen in animal studies were species-specific and did not apply to humans, clearing a major obstacle to its plans for the drug. Moreover, the FDA has also agreed that the results of study ITI-007-302—where lumateperone did not show an advantage over placebo—do not preclude the biotech from submitting an NDA based on two other positive efficacy studies.

ICT has agreed to carry out a long-term safety study of the drug that, if clear, will allow it to move ahead with a filing for the drug, once tipped as a potential $2 billion-a-year blockbuster.

Lumateperone is a dopamine receptor phosphoprotein modulator (DPPM) with selective action on dopamine D2 receptors, serotonin 5-HT2A receptors and dopamine D1 receptors, a profile that ICT says distinguishes it from other antipsychotic drugs and could enhance its effects on negative symptoms of schizophrenia such as social withdrawal.

It also seems to be less likely to cause weight gain and cardiovascular side effects, according to the results of a recent open-label study, and can be delivered at a fixed dose to all patients while many current schizophrenia therapies need to be titrated to an active dose.

It will need to convince prescribers of its advantages over established schizophrenia therapies if it is to carve out market share in what is becoming a highly generic market for this type of therapy, with a swath of former blockbuster drugs losing patent protection in recent years.

ICT says two studies with risperidone as active control showed statistically significant safety and tolerability benefits for lumateperone over the comparator drug.