Successful antipsychotic drugs can generate yearly sales in the billions, and that’s the type of thing Intra-Cellular Therapies is shooting for with an experimental schizophrenia drug called ITI-007. There’s still much to prove for that to happen, but this morning the New York-based company took a positive step forward.
Intra-Cellular (NASDAQ: ITCI) said today that its prospective schizophrenia drug ITI-007 succeeded in the first of two Phase 3 trials. The higher of two doses of the drug (60 mg) met the primary and all key secondary goals of the study (the lower, 40 mg dose, did not). Specifically, after four weeks of treatment, the 60 mg dose of ITI-007 led to a statistically significant improvement in patients’ scores on the Positive and Negative Syndrome Scale (PANSS) and the Clinical Global Impression Scale for Severity of Illness—two common ratings scales used to judge the effectiveness of treatments for schizophrenia and other mental health disorders—compared to a placebo.
The most common side effects experienced by patients in the study were drowsiness, fatigue, and mild sedation, though Intra-Cellular said these effects were “generally mild.” Intra-Cellular also said the drug didn’t lead to a significant difference in weight, or other metabolic measures like cholesterol and triglycerides, over the course of treatment. These were only top-line results, however, so no figures were available; Intra-Cellular will present the full data at a future medical meeting.
Shares of Intra-Cellular surged about 42 percent in pre-market trading on Wednesday.
Still, while the results are positive, Intra-Cellular isn’t clear to head to the FDA just yet. First, ITI-007 did best a placebo, but not by much. Patients on ITI-007 saw their PANSS scores improve by 14.5 points, compared to a 10.3 point improvement for those on placebo. Second, the bar is much higher for Intra-Cellular’s second Phase 3 trial. Patients in that study are being treated for six weeks instead of four, and ITI-007 is going up against a standard-of-care schizophrenia treatment, risperidone (Risperidal), not a placebo. That 500-plus patient study will produce results in the second half of 2016, and will tell a more significant story about ITI-007’s value as a potential schizophrenia treatment. The drug is a small molecule meant to act on serotonin, dopamine, and glutamate levels in the brain.
Intra-Cellular will host a conference call later this morning to discuss today’s results.
“We are very encouraged by the positive results of our first Phase 3 trial. These data confirm the findings from our previous placebo- and risperidone active-controlled, randomized Phase 2 trial. The antipsychotic effect of 60 mg is confirmed and shows itself to be well-tolerated along with a safety profile similar to placebo,” said Intra-Cellular’s CEO and chairman, Sharon Mates, in a statement. “Patients deserve a treatment choice which gives them symptom relief without the associated movement disorders, metabolic disturbances or cardiovascular effects observed with many antipsychotics. We are excited about our progress towards delivering a novel treatment option for patients.”
Image courtesy of flickr user DJ via Creative Commons.