San Diego-based BrainCells Inc. surprised the field of psychiatry last August, when a clinical trial showed that it could relieve symptoms of depression with an odd combination of an anxiety drug and a common dietary supplement. Six months later, the company is in the thick of plotting the next steps to turn this into a potential commercial hit.
In its provocative study of 142 patients, BrainCells showed that a low-dose generic buspirone, an anti-anxiety med, and the dietary supplement melatonin were able to achieve “comparable” effectiveness to standard treatments, known as selective serotonin reuptake inhibitors, according to Mauricio Fava, the vice chair of psychiatry at Massachusetts General Hospital. The company has been pretty quiet since then, but I caught up with BrainCells CEO Jim Schoeneck and chief scientist Carrolee Barlow a couple weeks ago at the JP Morgan Healthcare Conference to find out more about where BrainCells is going to take this drug in the future.
The data to support the BrainCells drug is potentially a big deal both scientifically and medically. The new drug is thought to have a completely different way of working than standard meds, by stimulating the growth of new neurons in the brain, what’s known as neurogenesis. The new mode of treatment could have a big impact on mental health, because an estimated 20 million people in the U.S. suffer from depression, the standard drugs don’t work for everybody, and they can cause side effects like weight gain and sexual dysfunction. The BrainCells combination drug didn’t show any side effects like that, so it might be an important new option for millions.
“The depression data we showed has really been the big story over the past few months,” Schoeneck says.
Before anybody gets too excited, this drug isn’t going to arrive at the corner pharmacy anytime soon. BrainCells still has a lot of work to do before it can leap ahead into a pivotal trial that could win FDA clearance to start selling the drug, code-named BCI-952. The earlier trial involved separate pills containing buspirone and melatonin. That’s not really commercially practical because both drugs are cheap and commonly available as individual components, and it’s hard to make sure patients regularly comply with a two-drug regimen.
So BrainCells has been working on turning BCI-952 into a proprietary oral pill that would be taken once a day, before bedtime, Schoeneck says. The company is also working to make sure it has strong intellectual property around this new molecule, he says.
Once the company is confident that it has the formulation right, it will run a similar mid-stage clinical trial. Schoeneck wouldn’t say much about what this trial will look like, but it will be a rigorous study in which patients are randomly assigned to get the drug or a placebo, and doctors and patients won’t know which is which.
The data is obviously important, but the company has been explaining to a lot of its peers in the neurology world how it came up with such a surprising finding without just chalking it up to luck. That requires a bit of explanation of BrainCells’ drug discovery platform. Back in December, Barlow said she was “swarmed” when she gave a poster presentation at the American College of Neuropsychopharmacology (try saying that one five times fast).
BrainCells, as I described in this feature back in December 2008, was built on a combination of technologies from the labs of Fred “Rusty” Gage at the Salk Institute, and Rene Hen and Eric Kandel at Columbia University. The platform uses neural stem cells to create adult … Next Page »
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