NEW YORK, Aug. 07, 2019 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (Nasdaq: ITCI), a biopharmaceutical company focused on the development of therapeutics for central nervous system (CNS) disorders, today provided a corporate update and announced its financial results for the second quarter ended June 30, 2019.

“We continue to advance our lumateperone schizophrenia program and prepare for commercial launch pending FDA approval,” said Dr. Sharon Mates, Chairman and CEO of Intra-Cellular Therapies. “In addition, we are pleased with the progress we have made in our other development programs, in particular our recent positive results with lumateperone for the treatment of bipolar depression.”

Corporate Update

Lumateperone Programs

Schizophrenia

• Our new drug application (NDA) for lumateperone, an investigational agent for the treatment of schizophrenia, is under review by the U.S. Food and Drug Administration (FDA). We recently met with the FDA and reached agreement to submit additional non-clinical information in connection with the FDA’s ongoing review of our NDA for lumateperone for the treatment of schizophrenia. The FDA has informed us that the planned submission of this additional information constitutes a major amendment to the NDA, resulting in a three-month extension of the Prescription Drug User Fee Act (PDUFA) goal date to December 27, 2019 in order to provide time for a full review of the submission. We intend to provide the FDA with the requested information in the coming weeks and we believe this information will be sufficient to address the FDA’s requests.
• We continue to make substantial progress in establishing our commercial capabilities and infrastructure to support the potential launch of lumateperone in the first quarter of 2020, pending timely FDA approval of the NDA. All manufacturing and supply chain related activities remain on track to support commercial supply. Our build-out of sales, marketing and managed care functions to support commercial operations and launch are also on track.
• At the 2019 American Psychiatric Association (APA) annual meeting, we presented posters highlighting lumateperone’s favorable safety and tolerability profile in schizophrenia clinical studies. In addition, we successfully launched our disease awareness campaign to highlight the significant unmet medical needs that remain in the treatment of schizophrenia.

Bipolar Depression

• We presented positive topline results in our bipolar depression program from Study ‘404, a Phase 3 trial of lumateperone in patients with bipolar depression. Study 404 met its primary endpoint of change from baseline at Week 6 on the Montgomery-Åsberg Depression Rating Scale (MADRS) total score versus placebo (p<0.001; effect size = 0.56). These benefits were statistically significant in both Bipolar I and Bipolar II patients. The study also met its key secondary objective on the Clinical Global Impression Scale for Bipolar for Severity of Illness (CGI-BP-S) Total Score (p<0.001; effect size = 0.46); lumateperone was also positive on the CGI component that specifically assesses depression (CGI-BP-S Depression Score; p<0.001; effect size = 0.50). In a second Phase 3 trial, Study ‘401, lumateperone did not separate from placebo. A high placebo response was observed in the trial. In both trials, lumateperone demonstrated a favorable safety profile and was generally well-tolerated. Importantly, the rates of akathisia, restlessness and extrapyramidal symptoms combined were less than 1% and similar to placebo in both studies. This safety profile is consistent with previous studies in patients with schizophrenia and provides further evidence supporting lumateperone’s favorable safety and tolerability profile across different patient populations. We plan to present additional details at upcoming medical conferences later this year. Our global adjunctive bipolar depression study, Study ‘402, is ongoing.

Major Depressive Disorder

• We believe lumateperone has the potential to exhibit potent and rapid antidepressant effects and have an ongoing program in major depressive disorder. In order to explore the effect of different modes of drug administration and the potential for rapid-onset antidepressant activity, our program includes the assessment of novel formulations of lumateperone. We are continuing to explore the pharmacokinetics of these formulations.

Other Programs

ITI-214 Program

• Our randomized, double-blind, placebo-controlled study of escalating single doses of ITI-214, our phosphodiesterase 1 (PDE1) inhibitor, to evaluate hemodynamic effects and safety in patients with systolic heart failure is ongoing. Clinical conduct for the second cohort, 30 mg, is ongoing following completion of the 10 mg dose cohort where no safety concerns were identified. In addition, we are evaluating a Phase 2, proof-of-concept clinical trial of ITI-214 for the treatment of Parkinson’s disease. We are also exploring ITI-214 and other PDE1 inhibitors in other CNS and non-CNS indication.

ITI-333 Program

• We plan to develop ITI-333, our novel, oral modulator of serotonin, dopamine, and mu opioid receptors, for the treatment of opioid and other substance use disorders, pain, and mood disorders. We expect to initiate our clinical program in late 2019 or early 2020.

Selected Second Quarter 2019 Financial Results

Intra-Cellular Therapies (the Company or ITCI) reported a net loss of $37.4 million, or $0.68 per share (basic and diluted), for the second quarter of 2019 compared to a net loss of $37.4 million, or $0.68 per share (basic and diluted), for the second quarter of 2018.

Research and development (R&D) expenses for the second quarter of 2019 were $23.7 million, compared to $32.4 million for the second quarter of 2018. This decrease of $8.7 million is due primarily to a decrease of approximately $10.6 million associated with the lumateperone development programs and a decrease of approximately $3.6 million associated with non-lumateperone projects and overhead expenses, which is partially offset by $4.8 million for lumateperone non-clinical efforts and an increase in labor and stock compensation expense.

General and administrative (G&A) expenses were $15.4 million for the second quarter of 2019, compared to $6.7 million for the same period in 2018. The increase of $8.7 million is primarily the result of an increase in pre-commercialization costs of approximately $5.7 million, and to a lesser extent, labor, stock compensation and rent expense.

Cash, cash equivalents and investment securities totaled $285.3 million at June 30, 2019, compared to $347.5 million at December 31, 2018.

We expect these existing funds will be used primarily for pre-commercialization activities, initial commercialization activities and related infrastructure expansion in connection with the commercialization of lumateperone, if approved, for the treatment of schizophrenia; the development of lumateperone in our late stage clinical programs; the development of our other product candidates, including ITI-214; the continuation of manufacturing activities in connection with the development of lumateperone; and general operations.

About Intra-Cellular Therapies

Intra-Cellular Therapies is developing novel drugs for the treatment of neuropsychiatric and neurodegenerative diseases and diseases of the elderly, including Parkinson's and Alzheimer's disease. The Company is developing its lead drug candidate, lumateperone (also known as ITI-007), for the treatment of schizophrenia, bipolar disorder, behavioral disturbances in patients with dementia, including Alzheimer's disease, depression and other neuropsychiatric and neurological disorders. Lumateperone is under review by the FDA for the treatment of schizophrenia and is in Phase 3 clinical development for the treatment of bipolar depression. The Company is also utilizing its phosphodiesterase (PDE) platform and other proprietary chemistry platforms to develop drugs for the treatment of CNS and other disorders. The lead molecule in the Company's PDE1 portfolio, ITI-214, is in development for the treatment of symptoms associated with Parkinson's disease and for the treatment of heart failure.