Intra-Cellular Therapies, Inc. (ITCI - Free Report) announced disappointing top-line data from the second phase III study (Study ‘302) on its lead pipeline candidate, ITI-007, for the treatment of schizophrenia. We expect investors to react negatively to the news.
The randomized, double-blind, fixed-dose, placebo- and active-controlled inpatient study was conducted in 696 patients who were randomized to receive ITI-007 (60 mg or 20 mg), or Johnson & Johnson’s (JNJ - Free Report) Risperdal (risperidone) (4 mg) as the active control, or placebo. Data revealed that, none of the doses of ITI-007 showed treatment effect in patients than those on placebo, on the primary endpoint – change from baseline on the Positive and Negative Syndrome Scale (measures the ability of a drug to reduce schizophrenia symptom severity) total score. However, Risperdal showed improvement when compared to placebo.
Intra-Cellular attributed such results, in part to an unusually high placebo response at certain sites, which disproportionately affected the study results.
However, ITI-007 was found to be statistically significant than Risperdal on key safety and tolerability parameters, and demonstrated a safety profile similar to placebo. The company plans to continue with the development of ITI-007 for the treatment of schizophrenia, and intends to request a meeting with the FDA’s Division of Psychiatry Products, to discuss the regulatory path forward for the candidate.
Meanwhile, Intra-Cellular remains dedicated with its plans to develop ITI-007 for the treatment of bipolar depression, agitation associated with dementia, including Alzheimer's disease and other neuropsychiatric indications.
With no approved product in Intra-Cellular’s portfolio at the moment and ITI-007 being the company’s most advanced candidate, the reported study results are concerning.
Considering that currently available treatments for schizophrenia carry side effects including movement disorders, weight gain, metabolic disturbances and cardiovascular disorders, there remains significant unmet medical need for new treatment options.
We note that, quite a few companies have faced setbacks in their efforts when developing drugs for antipsychotic disorders, including depression and schizophrenia. Earlier this year, Alkermes plc (ALKS - Free Report) announced disappointing preliminary top-line results from the first two of its three phase III efficacy studies on ALKS 5461. No treatment effect was observed in patients who received ALKS 546 while placebo response was observed to be greater.
A Stock to Consider
A better-ranked stock in the health care sector is Anika Therapeutics Inc. (ANIK - Free Report) , sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
For 2016, Anika witnessed a 12.6% increase in its earnings estimates over the past 60 days. It has recorded an average positive earnings surprise of 42.19% over the last four trailing quarters. The company’s shares have jumped 22.8% year to date.
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