With these data in hand, we intend to meet with the U.S. Food and Drug Administration (FDA) to determine the late stage clinical strategy and more specifically the design of the next clinical trials with MIN-101. Our objective is to initiate these trials in mid-2017.
today announced that it will host a conference call and live webcast discussion at 8:30 a.m. Eastern Time on Wednesday, November 9, 2016, to provide a corporate update and discuss details of the Company’s financial results for the quarter ended September 30, 2016.
May both of this passes its final hurdle…!!!
For min-101…
1.Data from the extension of the Phase IIb trial with MIN-101 demonstrate a
further and continuous improvement in negative symptoms in patients
with schizophrenia, as measured by the negative symptoms subscales of
the Positive and Negative Syndrome Scale (PANSS). Based on the PANSS
pentagonal structure model (PSM), negative symptoms were observed to
continue to improve during the extension phase, with a reduction from
the start of the study for the 32 and 64 milligram (mg)
MIN-101-treated groups of 5.5 points and 4.9 points, respectively.
Based on the PANSS three factors negative symptoms subscale, negative
symptoms were also observed to continue to improve, with a reduction of
5.4 points and 5.3 points, respectively.
I read that because MIN-101 has an antagonist effect at the Sigma-2 receptor, it may improve some cognitive functions. Despite MIN-101 being an 5-HT2A receptor antagonist as ITI-007, it can work because of its add.
I think we can forget about ITI-007 when it comes to schizophrenia. It might do something for bipolar…who knows. MIN-101 is so far off…it’s not even in Phase III. There is so much daylight between Phase IIb and FDA approval, it’s silly. Soooo many drugs get shot down in that time span. I think it would be wise for all to hedge their bets until Phase III results trickle in. RP5063 is coming along, but it looks to possibly have oodles of side effects.
I can remember when olanzapine was touted as the next clozpaine without blood tests and side effects. It is an effective med, but it certainly has its issues. There have been so many “savior” meds that have turned out to be just so-so. Schizophrenia is so complex that scientists have no idea how to treat it, much less with a one-shot one-kill approach of wrapping the treatment up into a single chemical. Science just isn’t to that point.
Baby steps, I think that’s about all we can hope for.
RP5063 seems to be promising for the cognitive symptoms. Maybe it can deal with alogia. But I can’t find much information about this med on internet. I’m afraid it can fail as ITI-007 did.
I think the best that we can hope for is an antipsychotic that doesnt cause weight gain, eps, and sexual side effects. I believe they will develop a drug that can do this but I predict that it will take another 7-10 years.
yes drug development process is very lengthy …got exhausted searching for cure…!!![quote=“brugluiz, post:11, topic:63365”]
Pimavanserin
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Wow, it’s already in Phase 3. When I read that article about 20 meds being developed in 2015, it was still in Phase 1. Sad it doesn’t target negative and cognitive symptoms.
Wow, hopefully we will have a cognitive enhancer at some point, I was really excited about encenicline then it suddenly failed phase 3.
It was supposed to work by the same mechanism as abt-126, a7nachr agonism, hopefully that mechanism works for cognition. Another medication I’m waiting for is aqw051 (I think that’s what it’s called) hopefully they’re still testing it, but I don’t think they are.
) because they have the mechanism. The same may happen with MIN-101.