ITI-007 updates

http://ir.intracellulartherapies.com/releasedetail.cfm?ReleaseID=1015089

Corporate Update

We have a meeting scheduled with the FDA in late March 2017 to discuss the submission of a New Drug Application (NDA) for lumateperone for the treatment of schizophrenia. We expect to provide an update on the status of our discussions following this meeting.
We had a positive pre-NDA meeting with the FDA regarding the Chemistry, Manufacturing and Controls (CMC) data package. Additionally, we have signed a long-term agreement with a third party manufacturer for the supply of lumateperone in commercial quantities.

We presented the results from the lumateperone clinical development program in schizophrenia at the 55th Annual Meeting of the American College of Neuropsychopharmacology (ACNP) and at CNS Summit.
We plan to present additional data on our development programs at several upcoming scientific and medical conferences including the International Congress on Schizophrenia Research (ICOSR), the Society of Biological Psychiatry (SOBP), the American Psychiatric Association (APA), the International Society for Bipolar Disorders (ISBD) and the International College of Neuropsychopharmacology (CINP).
Clinical conduct in our Phase 3 programs in bipolar depression and in agitation associated with dementia, including Alzheimer’s disease, is ongoing. We continue to employ a number of strategies designed to ensure we recruit appropriately diagnosed patients in an effort to reduce the risk of a high placebo response. Patient enrollment in our Phase 3 bipolar depression monotherapy study, or Study ‘401, is expected to be completed in the first half of 2018. Patient enrollment in our Phase 3 bipolar depression adjunctive study, or Study ‘402, is expected to be completed in the second half of 2018. One of our strategies to optimize potential success in this program is to initiate a third trial in bipolar depression conducted globally. We anticipate patient enrollment in our global study to complete by the end of 2018.
We continue to advance our innovative PDE platform. ITI-214, the lead molecule in our PDE-1 program, has been shown to be safe and well-tolerated in four Phase 1 clinical trials to date in healthy volunteers as well as patients with schizophrenia. In the first half of 2017, we expect to initiate a Phase 1/2 clinical trial with ITI-214 in patients with Parkinson’s disease to evaluate safety and tolerability in this patient population as well as motor and non-motor exploratory endpoints. We continue to explore additional indications for our PDE1 inhibitors, including opportunities to advance the program into other CNS and non-CNS therapeutic areas, including cardiovascular diseases.
We continue to advance our pre-clinical programs including our ITI-007 long acting injectable program and we expect this program to enter clinical development in 2018.

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So, do they need to complete bipolar trials before they can gain acceptance from the FDA ? When are we looking at seeing this drug in the market?

Either not at all, or by the end of the year. It all depends on what the FDA says this month.

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So the bipolar trials are after said approval would be gained? We don’t have to wait until 2019 for approval of they file an application in March?

I think the FDA will either give approval or deny them in March for ITI-007 for schizophrenia.

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Let us pray for this one to be approvrd.
It could dramatically improve our lives

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If I remember, bipolar trials are ongoing. The meeting with FDA will determine if the company can submit New Drug Application for SZ. The NDA would have to be prepared and submitted by company and evaluated by FDA.

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What are the differences between ITI-007 and Vraylar? Is ITI-007 better? Vraylar is causing weight gain for me.

They must know more than us why this drug is effective, just judging by the fact that they failed phase 3 we the public have little reason to think it’s dependable, i don’t want to risk another psychosis frying my brain.

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Iti is unique, its a pre synaptic partial agonist and postsynaptic antagonist. Vraylar is a partial agonist with higher affinity for D3 than D2. Iti has a 59 fold higher affinity for 5ht2a over D2. This is supposed to have less side effects. Iti is supposed to cause no weight gain and only mild sedation. If it is released weight gain will no longer be an issue for us. Unfortunately it had a high placebo response in a stage 3 trial. So it might not actually work. This month the Fda is deciding whether to pursue it further.

Edivulgis, what’s your feeling on this med?
Do you think it will make it to the market?
What does a high placebo response mean?
Will it work?

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High placebo response means the control group who weren’t on the higher dose of iti-007 improved more than those on the high dose. The lower doses those on the new drug improved similarly to risperidone, the comparison drug. I personally don’t have a lot of hope for this drug, if it does come out in 2018 I will wait until many others have tried it to see if it works. Maybe the drug is just weird in that it is more effective at lower doses? The measurement of treatment response is very subjective in Sz unlike physical illnesses, additionally many people need more than 6 weeks to respond to a drug. So I don’t take results which are based on the PANSS seriously. I think we need to improve our measuring tape and start doing longer trials or something.

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Well, that’s relatively positive sounding, considering that the low dose might stil be effective.
I understand your trepidation about using this drug, I didn’t take into account that most drugs take more than 6 weeks to work. I’m on the fense about it.
The side effect profile is so tasty that it’s gonna be hard not to switch immediately if it gets released.
But then again I don’t know if I would risk another psychotic episode and the ensuing year and a half of recovery if it doesn’t work.

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Will this control psychosis

That’s what it is supposed to do

I’m excited but not getting my hopes up yet…

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It’s an experimental drug that is going in front of the FDA here in the states this month.

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Nice maybe I can say bye to this 5 month long psychosis…

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