The last patient has completed the 24-week open-label extension period of the Company’s Phase IIb clinical trial of MIN-101 in patients with negative symptoms of schizophrenia. Positive results from the prospective 12-week randomized, double-blind, placebo-controlled core phase of this trial were announced previously. These results from the core phase demonstrated statistically significant improvement of negative symptoms, the primary endpoint of the trial, in patients treated with both 32 milligrams (mg) and 64 mg daily doses of MIN-101 compared to placebo. Statistically significant benefit of MIN-101 was also demonstrated in multiple secondary endpoints.
Approximately 140 patients who completed the core phase of this trial entered the extension phase, during which all patients received one of the two doses of MIN-101. Patients who received placebo in the core study were randomized to one of these doses. As planned, the extension phase of the trial was completed in the third quarter of 2016, and the Company expects to announce top line results from this phase in the fourth quarter of 2016. The Company has submitted results from the core phase of the trial for peer-reviewed publication and presentations and plans to meet with regulatory authorities in the United States and Europe in preparation for Phase 3 testing of MIN-101, which is expected to begin in 2017.
MIN-101 is a drug candidate with equipotent affinities for sigma 2 and 5-hydroxytryptamine-2A (5-HT2A) and lower affinity at alpha1-adrenergic receptors. MIN-101 has no direct dopaminergic post-synaptic blocking effects, known to be involved in some side effects like extrapyramidal symptoms, sedation, prolactin increases and weight gain.
@jamesbond that’s for sharing…!!!
Hope that it will pass all the phases nicely…!!!
This AP looks good for negs. But how effective is it?
Is this just for negative stmptoms or would it suffice as an antipsychotic stand alone?
Promising drug, hopefully this one can make it past phase 3.
But what side effects will it have?
Well it would be nice if sz meds were like adhd meds and people actually wanted to take them. no weight gain, no sexual side effects, and no movement problems= life is good
i just wrote to the company to see it ifs stand alone for negatives or not, Its not to clear with the release if it is or not.
thanks,@opus. please us know what they say
Hopefully it’ll be out before 2020, I’m doing ok but I would love to try this. My antipsychotic gives me negative symptoms.
I just got a reply back this is what they said,
In response to your email, MIN-101 is under development as a treatment for negative symptoms of schizophrenia. Results of our recently completed Phase IIb trial (attached) showed a statistically significant improvement in negative symptoms, while positive symptoms were observed to remain stable.
MIN-101 is currently not available. Please note that additional testing will need to be initiated and completed successfully prior to submission for review to regulatory authorities. Results of this additional testing will help determine whether the treatment paradigm with MIN-101 will be as monotherapy or in conjunction with drugs to treat positive symptoms.
MIN-101 Phase IIb top line results.pdf (85.6 KB)
Nice job @opus you seem to have a way with the pharmaceutical companies!
Looks like that means it’s just for negatives although there’s a possibility it could be for both.
Yeah that seems to be the case, do you suffer from negatives? I know i do and would love a med to treat them.
I don’t know, it’s hard to say. Can’t tell if they are negatives or extreme depression. I used to have negatives like flat affect and bad cognitive problems after my first episode but ironically that all went away with time. Now I think the medication is responsible for my negative symptoms but I’m not about to stop it to find out. Kinda curious as to what a drug like min 101 would do for me. I definitely have some cognitive problems still. This drug may not even be right for me, but I’m excited about it for some reason.
Hope it passes the taste test and makes it to the market.
Are these results from the phase 2b trial they just completed, and said in Q4 they will have results? That’s what @firemonkey posted.
naw if you read that pdf it says its from may
From what I’ve read abt pharmacology this is basically iti-007 without any dopamine partial agonism/antagonism.
In response to your email, MIN-101 is under development as a treatment for negative symptoms of schizophrenia.
So it does nothing for positive symptoms. I’m not happy.
I think it does but thats not the main endpoint