FDA Clears Biohaven's Investigational New Drug Application for BHV-4157

[Hopeful1]

BHV-4157 is a new chemical entity (NCE) that modulates glutamate, one of the most important neurotransmitters in the brain that is present at more than 90% of all brain synapses. Agents that modulate glutamate neurotransmission may have therapeutic potential in multiple disease states involving glutamate dysfunction, including ALS, Alzheimer's disease, Rett syndrome, dementia, dystonia, tinnitus, anxiety disorders, and affective disorders like major depressive disorder.
http://www.prnewswire.com/news-rele...all-to-provide-business-update-585536951.html

 

[Beste]

This is the drug I have been waiting to hear some news from. Thank you for sharing!

 

[Pleasure_Paulie]

It seems to treat a very wide range of conditions. It will be interesting to see the side effect profile of such a drug!

 

[weab00]

Any news about this drug?

"In July 2018, Biohaven began a Phase 2/3 trial enrolling 292 patients with mild to moderate AD at 44 sites across the U.S. This trial is in cooperation with the Alzheimer's Disease Cooperative Study (ADCS). After an initial screening period of up to six weeks, participants are randomized to one 280 mg capsule of drug or placebo daily for 48 weeks, followed by four weeks of post-treatment observation. The primary outcome measure is change from baseline to 48 weeks on the ADAS-Cog11. According to a company press release, as of July 2019, around 400 patients had been screened and 180 randomized. A preplanned interim futility analysis is expected by the end of 2019; the trial ends in February 2020."

https://www.alzforum.org/therapeutics/troriluzole

They seem to have gone silent since 2018.

 

[tommyd87]

BHV-4157 in Adult Subjects With Obsessive Compulsive Disorder

 

[wwtsai]

Any news about this drug?

"In July 2018, Biohaven began a Phase 2/3 trial enrolling 292 patients with mild to moderate AD at 44 sites across the U.S. This trial is in cooperation with the Alzheimer's Disease Cooperative Study (ADCS). After an initial screening period of up to six weeks, participants are randomized to one 280 mg capsule of drug or placebo daily for 48 weeks, followed by four weeks of post-treatment observation. The primary outcome measure is change from baseline to 48 weeks on the ADAS-Cog11. According to a company press release, as of July 2019, around 400 patients had been screened and 180 randomized. A preplanned interim futility analysis is expected by the end of 2019; the trial ends in February 2020."

https://www.alzforum.org/therapeutics/troriluzole

They seem to have gone silent since 2018.

Looks like the trial ends in a few days:

Study of BHV-4157 in Alzheimer's Disease (T2 Protect AD)

 

[weab00]

Looks like the trial ends in a few days:

Study of BHV-4157 in Alzheimer's Disease (T2 Protect AD)

Phase 2 trial? Is this a channel blocker similar to Dr. Thanos's Retigabine?

 

[wwtsai]

Phase 2 trial? Is this a channel blocker similar to Dr. Thanos's Retigabine?

From Biohaven's website:

"Troriluzole is a third-generation prodrug and new chemical entity that modulates glutamate, the most abundant excitatory neurotransmitter in the human body. The primary mode of action of troriluzole is reducing synaptic levels of glutamate. Troriluzole increases glutamate uptake from the synapse, by augmenting the expression and function of excitatory amino acid transporters (i.e., EAAT2) located on glial cells that play a key role in clearing glutamate from the synapse."​

It's related to Riluzole which inhibits NMDA receptors and potentially blocks sodium channels. If the mechanism of action is the same for Troriluzole it wouldn't be similar to Retigabine as the latter is a potassium channel opener. This is way out of my breath so if someone more knowledgeable would like to chime in...

 

[Jak]

Has this drug been released to the market?

 

[wwtsai]

Has this drug been released to the market?

It's still in clinical trials so not yet.

 

[GBB]

BHV-4157 is a new chemical entity (NCE) that modulates glutamate, one of the most important neurotransmitters in the brain that is present at more than 90% of all brain synapses. Agents that modulate glutamate neurotransmission may have therapeutic potential in multiple disease states involving glutamate dysfunction, including ALS, Alzheimer's disease, Rett syndrome, dementia, dystonia, tinnitus, anxiety disorders, and affective disorders like major depressive disorder.
http://www.prnewswire.com/news-rele...all-to-provide-business-update-585536951.html

As with anything that modulates a neurotransmitter, do we avoid homeostatic counter production by the brain? I hope this functions differently than the typical Memantine, Ketamine etc...