New Medication coming down pipeline for Negative Symptoms

New Medication coming down the pipeline:

Schizophrenia

Phase 2b Clinical Trial

This randomized, double-blind, placebo-controlled, parallel, 12-week Phase 2b trial evaluated the
safety and efficacy of two doses of EVP-6124 (0.3 mg and 1.0 mg per day) versus placebo in chronic
schizophrenia patients on stable second-generation antipsychotic drugs (except clozapine). Each
patient was treated for three months and a total of 319 patients were enrolled in the U.S., Russia,
Ukraine and Serbia. The trial’s primary endpoint was overall cognition as measured by the CogState
overall cognitive index and important secondary endpoints included cognition as assessed by the
MCCB battery, clinical function (as measured by the SCoRS) and positive and negative symptoms
(measured by PANSS). Safety and tolerability were also assessed.

The data showed that EVP-6124 had a clinically meaningful and statistically significant impact on
patients’ overall cognition - the trial’s pre-specified primary endpoint - when taken in combination with
second-generation antipsychotics and as measured by the full CogState overall cognitive index, or
“OCI” (p=0.05 for all patients treated with EVP-6124 versus placebo.) This positive effect on the OCI
was supported by a strong positive trend for improved cognition on the MCCB Battery of cognition
tests, which were conducted on all U.S. patients in the trial.

Additionally, results from this Phase 2b trial demonstrated that patients treated with EVP-6124 (1.0
mg) showed clinically meaningful and statistically significant effects in key secondary endpoints:
improvement in clinical function (p=0.011; as assessed by the Schizophrenia Cognition Rating Scale
(SCoRS)) and reduction of the negative symptoms of schizophrenia (p=0.028; as measured by the
Negative Symptom Scale of the Positive and Negative Symptoms Scale (PANSS)).

Importantly, EVP-6124 was generally safe and well-tolerated over the trial’s three-month dosing
period. The most commonly reported adverse events were headache, nausea and nosopharyngitis
(all less than four percent), there were no drug-related serious adverse events.

En-Vivo is encouraged by the results across both dose arms and the broad range of primary and
secondary endpoints. They are now working with leading clinicians and researchers to finalize the
design of their Phase 3 Clinical Trials to maximize these learning.

This company is now called "Forum Pharmaceuticals - and here is a link to their web information:

http://www.forumpharma.com/disease-areas/schizophrenia.html

4 Likes

God almighty please let this medication work to treat negative symptoms I’m suffering beyond belief I can’t take this.

2 Likes

Yes, I’m waiting for these drugs to come out too. I’ve had mainly negative symptoms most of my life.

1 Like

Is it manegable for you?

It’s for cognitive mainly

Yes. With the mix of meds I found over several years of trying different ones. Each one brought another degree of comfort to my life. I take an antidepressant, two antipsychotics, lithium and neurontin. I’m OK.

0.011 is a great result. On another note does this mean phase 3 hasn’t started yet?

What does 0.011 mean?

It means there’s only a 1.1% chance that there results are wrong.

Phase 3 clinical testing has been initiated, I’ve been told by people associated with the company.

This is Encenicline. It is also supposed to help with quitting smoking. Heard it should help with memory and cognition. I am signing up for the trial in September.

1 Like

Apparently it’s a partial agonist on the a7 nicotinic acetylcholine receptor.

So it’s like tobacco with a specific target and more control. Definitely a better alternative to cigarettes.

I wonder if it’s gonna cost an arm and a leg when it comes out like ability does.

Right - here is more info:

http://www.alzforum.org/therapeutics/encenicline

more good news

http://decisionresources.com/News-and-Events/Press-Releases/EnVivo-3-31-2014

Okay this is good and all but the people who are REALLY suffering are people like me with chronic negative symptoms, we have it worse than any other schizophrenics, I know this from what I’ve learned and what I’ve heard from those who have both. I have mainly negative symptoms and it is hell on earth I’m doing much worse than the people in this website. I am suffering and I am in total hell. I can’t find to many people like me, but I’m trying. We need to find treatment for negative symptoms this is the most disabilitating symptom and the kst impossible to treat. I’m completely desparate.

Oh trails don’t end until the end of 2016 that’s still along time away, still fingers crossed thanks for the updates SzAdmin.
By the way Spokety I think its hard to tell how much people suffer negative symptoms just from reading forums, Im sure allot of us are in the same boat.

1 Like

@Opus No it’s very easy to tell you know why? Because you people have bad days and good days. I don’t have good days, every day of my life is pure misery, people on here talk about getting excited for something or liking this song, but that doesn’t happen for me because I have NO emotions absolutely nothing, I live in hell, I’m tortured everyday and no medication can give me even the slightest bit of difference.
@SzAdmin When will phase 3 trials be over for Evp-6124

Hi, my son has mainly negative symptoms now, although it took quite a while to get the positive symptoms under control. I am activley searching for any ideas about treatment for negative symptoms. I would love to chat with you guys about ideas and potential treatment.

How does your son describe how he feels due to negative symptoms?

The only time hes really descriptive/ talkative is when hes taken ritalin. He doesnt seem to have insight into thesymptoms sz has on him. Hes just living it out. When he has taken ritalin its like he is the person without sz for that time. He can talk with people be perseptive connect and be warm and caring and stay connected into conversations. Then hes told me it makes it easier for him to concentrate and he feels more relaxed and confident. Hes made friends and started socializing again after 3 years of not since he started taking ritalin socially. The next day or 2 after hes back to polite but cold. Which is acceptable as we are just glad hes functioning with some quality of life. After seeing how warm he could be it gave us some hope that he can have intjmate carjng relationships. If there is some kind of therapys available for negative symptoms. Thats legal and without the danger of flaring up the positive symptoms. (They were really scary and dreadful). We are gojng to the psychiatrist on tuesday to have this discussion.