Psychiatry KOL Insight Interview
Psychiatry KOL Insight Interview
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At SfN, they showed some interesting preclinical data on the affect on the 5-HT7 and how it works in some animal models of cognition…especially those injected with PCPA. And you know in depression, they also did what we call the chronic mild stress (CMS)
Publisher: Biomedtracker
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KOL Highlights Include:
- Brintellix (vortioxetine) is expected to have positive data on cognitive endpoints in patients with Major Depressive Disorder (MDD) based on 5-HT7 target. KOL is interested in the company’s assessment of cognition. MATRICS would be the ideal measure. (Takeda)
- Akathesia is not a deal-breaker for cariprazine even after CRL in schizophrenia and bipolar disorder. Results expected soon for the use of cariprazine as an add-on in MDD. (FRX)
- Ketamine can be efficacious in MDD, but so far attempts to improve on its safety profile by rapid association/disassociation or by targeting NMDA receptor subunits are unproven/unsuccessful.
- mGluR allosteric modulators have not been effective in the clinic. (ADX, NVS, Roche)
- KOL believes antibody therapies for Alzheimer’s Disease still have potential for disease modifying outcomes. (LLY, Roche)
- KOL questions scientific rationale for pimavanserin in Alzheimer’s disease psychosis. (ACAD)
- Highlights
- We were recently in attendence at the Society for Neuroscience (SfN) annual meeting. We would like your opinion on the most exciting preclinical and Phase I data that were presented at the meeting in development?
- Do you there’s some possibility for this mechanism to be used in either schizophrenia or depression?
- The 5-HT7 targeting would not help negative symptoms of schizophrenia?
- What about something like bipolar depression?
- This study was completed in May 2013, but they haven’t released data yet?
- What do you think would be an ideal endpoint for cognitive dysfunction in MDD?
- There are a couple others in earlier development.
- Have they shown any cognitive improvement with lurasidone?
- The RESOLVE-I study is estimated to be completed in Q2 2014.
- Supernus has a compound that targets 5-HT7, which is preclinical but they submitted an IND. Do you know anything about this compound?
- Glyx-13 is a compound in development that has a different mechanism.
- There’s a compound today that got regulatory fast track status, an NR2B targeted compound called Cerc-301. It’s being developed by Cericore in collaboration with Merck.
- Do you envision ketamine as similar to electoconvulsive therapy (ECT) in that you would use it in a recovery case where you can jump-start the system as opposed to having something you take for a long period. As a reset?
- Can you discuss the clinical failure targeting NR2B?
- Do you have any opinions on mGlur5 as a target? There seem to be potential safety issues with these compounds?
- Do you think allosteric modulators could be beneficial for Fragile-X?
- There’s a Phase II/III trial in Fragile-X where maybe there you have a better likelihood of success?
- They got a complete response letter. They had a 3-6 mg flexible dose, and a 6-12 mg flexible dose in bipolar mania. And it looks like their 6-12 mg dose performed similarly to the 3-6 mg dose on efficacy but had worse akathesia and other side effects based on that dose, so I don’t know if whether that’s one of the issues?
- Akathesia looks pretty similar to other atypicals as it does with cariprazine. Given the fact that its efficacy is right on par with other atypicals, do you think that it would be competitive in this space since you don’t really see a huge reduction in akathesia?
- They released data in MDD a couple of years ago?
- What cariprazine data did you find interesting that was presented at SFN?
- So you had mentioned that there were a number of early stage compounds. Is there something that struck you as novel as far as target goes and not recycling the same targets that we’ve currently been using in psychiatric disorders?
- If you had to bet on 5-HT6 or a nicotinic receptor mechanism, which would you pick?
- What if amyloid hypothesis fails (solanezumab, gant and Merck’s BACE inhibitor) and basically lowering amyloid doesn’t actually alter the course of disease, where do we go from there? What I’ve been seeing is there’s sort of been an increased interest in Tau-related therapies?
- Antipsychotics have a black box warning in the elderly.
- Do you think that given the results in Parkinson’s disease psychosis for Pimavanserin, do you think there is hope in AD psychosis?
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