The National Weather Service reports that there are some breaks in the thick layer of clouds and fog which has covered the CNS space for much of the past year. While there are not yet clear signs of a summer heat wave, conditions are expected to moderate and become more temperate.
The gloom had approached nuclear winter hues after the unexpected failure of the TC-5214 Treatment-Resistant Depression program from AstraZeneca/Targacept, which catalyzed AstraZeneca’s radical remodeling of their neuroscience program, and set the psychiatry community to wondering whether depression had become inaccessible as a target for new therapies. But as the first six months of 2012 drew to a close, there were some positive data reports that should start to lift the mood of those trying to push the neurotherapeutics field forward, even as others edge towards the exits. We heard positive late-stage trial results from Forest/Pierre Fabré, Sunovion, and Lundbeck/Takeda, and there is data yet-to-be-announced from two other CNS trials which will have a dramatic impact when publicly disclosed.
The pessimistic wait for results from bapineuzumab and solaneuzumab (formal presentations in October) continue to cast a shadow over the landscape. But ‘bapi’ and ‘sola’ do not define neuroscience, they do not even define the amyloid hypothesis, given that they were administered too late to prove anything in the developmental cycle of Alzheimer’s. There are other events that will prove to be much more important. Below is a noncomprehensive roster of programs that will produce Phase II and Phase III data over the next eighteen months, and from those, there will be ample good news.
Allon Therapeutics Davunetide PSP
CeNeRx TriRima Depression
EnVivo EVP-6124 Alzheimer’s
Targacept TC-5619 Schizophrenia
Targacept/AstraZeneca AZD3480 Alzheimer’s
Acadia Pimavanserin Parkinson’s psychosis
Ceregene CERE-120 Parkinson’s
Naurex GlyX-13 Depression
Catalyst CPP-109 Cocaine addiction
Intra-Cellular Therapies ITI-007 Schizophrenia
Marinus ganaxolone PTSD
Seaside Therapeutics Arbaclofen Autism
Zalicus Z160 Neuropathic pain
Euthymics Bioscience EB-1010 Depression
Biogen-Idec/Knopp Dexpramipexole ALS
JNJ/Pfizer/Elan Bapineuzumab Alzheimer’s
Neuren NNZ-2566 TBI
Adamas Nurelin Parkinson’s
Lilly Solaneuzumab Alzheimer’s
JNJ/Addex ADX71149 Schizophrenia, depression