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gamma secretase functions—but not to shut the enzyme down all together. “It affects amyloid processing but leaves Notch processing alone,” Been says.
The Phase 1 trial will test multiple doses of EVP-0962 in healthy volunteers to determine its safety profile. EnVivo expects to finish the trial by the end of the year and hopes to start Phase 2 trials to determine the drug’s effectiveness in 2012.
EnVivo will probably need to find a Big Pharma partner to take the drug all the way through the clinical-trial process, Been says. “We’ll have to dose patients for a long time to test for disease modification. That’s the only way to separate the natural decline in Alzheimer’s from the effect of the treatment,” Been says. “But that’s a long and expensive affair.”
For now, EnVivo has the benefit of patient investors, Been says. In 2008, Fidelity Biosciences poured $65 million into the company in a Series D, buying out all of the previous investors, which included BCM Technologies, Cogene Ventures, and NeuroVentures Capital. EnVivo and Fidelity BioSciences are now developing a funding plan to get the startup through the next few years, Been says.
In addition to moving EVP-0962 through the clinic, EnVivo is continuing to explore a class of drugs known as alpha-7 agonists. The company’s lead compound, EVP-6124 seems to improve cognitive functioning in both Alzheimer’s and schizophrenia. It works by enhancing the transmission between synapses in the brain. EnVivo recently announced positive Phase 2 results from a trial in schizophrenia, and it expects to release Phase 2 results in Alzheimer’s next year.
EnVivo also has a number of novel molecules in its early-stage pipeline, including two that Been hopes will make it into clinical testing by the end of the year or early next year. “Our strategy is to build a broad pipeline,” he says. When it comes to diseases of the nervous system, he adds “We’re not believers in only one mechanism.”
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