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Intra-Cellular Shares Continue to Climb on Positive Results

Intra-Cellular Therapies Inc. (NASDAQ: ITCI) continues to dominate the biotech industry as its shares are up nearly 50% year to date and over 80% in the past 52 weeks. However, shares made another incredible move on Wednesday morning on positive results. The company announced positive results from the first Phase 3 clinical trial of ITI-007 for the treatment of patients with schizophrenia.

Intra-Cellular is developing novel drugs for the treatment of neuropsychiatric and neurodegenerative diseases and diseases of the elderly, including Parkinson’s and Alzheimer’s.

In this trial, once-daily ITI-007 60 mg met the primary endpoint and demonstrated antipsychotic efficacy with statistically significant superiority over placebo at week 4 (study endpoint).

These findings confirm the positive results demonstrated by ITI-007 60 mg in the Phase 2 study. Consistent with previous studies, ITI-007 had a favorable safety and tolerability profile as evidenced by motoric, metabolic and cardiovascular characteristics similar to placebo, and no clinically significant changes in akathisia, extrapyramidal symptoms, prolactin, body weight, glucose, insulin or lipids.

The trial achieved efficacy at lower dopamine receptor occupancy levels more commonly associated with clozapine. To some, this is arguably the most efficacious antipsychotic. At the same time, it maintains a placebo-like safety and tolerability profile, which is a remarkable advance in the development of drugs for schizophrenia.

Dr. Sharon Mates, chairman and CEO of Intra-Cellular Therapies, commented on the 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. 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.

Shares of Intra-Cellular were up 64.7% at $43.01 Wednesday morning, in a previous 52-week trading range of $12.67 to $37.81. The stock has a consensus analyst price target of $48.00.

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By Chris Lange


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