Date: Jan 22, 2014 Author: Don Seiffert Source: bizjournals (
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Deborah Dunsire, former CEO and president of Millennium Pharmaceuticals, has been CEO at EnVivo Pharmaceuticals since last August.
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Don Seiffert
BioFlash Editor- Boston Business Journal
EnVivo Pharmaceuticals, a privately-held biotech headed by former Millennium Pharmaceuticals CEO Deborah Dunsire, has begun a late-stage trial involving 1,600 patients of a potential drug for Alzheimer's disease.
The disease, which causes dementia, is expected to increase exponentially in coming years, at a time when most other diseases - including cancer, heart disease and diabetes - are on the decline. Yet few companies are developing drugs for Alzheimer's, and Dunsire says she believes that's largely due to the difficulty in measuring effectiveness of neurology drugs.
"I think we've seen some companies step away from neuroscientific endpoints," she said. The usual measures involve cognitive tests, she said, and "the placebo effect has always been very high." Additionally, getting drugs from the bloodstream into the brain is a challenge in itself.
Dunsire, who joined Watertown-based EnVivo last August a few months after leaving Millennium, said the company licensed the drug, called encenicline, from Bayer Pharmaceuticals nearly nine years ago. The company has taken it through mid-stage clinical trials in both schizophrenia and Alzheimer's, involving 319 and 409 patients, respectively. Last February, Envivo began a Phase 3 trial of the drug in schizophrenia. Dunsire said the current trial will take between a year and 18 months to enroll all 1,600 patients, and results won't be available for at least a couple years.
The drug works differently than a lot of others in development, she said.
Alzheimer's is inflammation in the brain thought to be caused by tau tangles, which are in turn caused by a buildup of beta-amyloids outside the neurons. Several drugs, including ones developed by drug giant Eli Lilly, are aimed at reducing the buildup of beta-amyloids, but encenicline is intended to increase the residual functions of memory and cognition in the brain, and thereby slow progression of the disease. It has no effect on the levels of beta-amyloids.
The trial will test encenicline in two different doses against a placebo for six months, after which any patients on a placebo will be given the chance to continue with encenicline.
EnVivo has grown quickly in the past year leading up to the large, late-stage trials. At the beginning of 2013, it had 70 employees, said Dunsire, while today it has about 160. She said it will grow even more in the coming year. It is funded entirely by Fidelity Biosciences, and hasn't disclosed how much has been invested to date.
Dunsire said it's been exciting to move from one of the area's largest public biotechs to a much smaller, private one, where every employee is even more essential to the overall mission.
"That's the joy of a small company. Everybody who shows up in essential. There's no buffer," she said.
