Contributing Writer

The public markets are obsessed with late-stage product plays, and venture capitalists are following that trend these days. In the first eight months of the year, 73 percent of the cash raised in Series A financings went to companies with products already in the clinic

But preclinical-stage EnVivo Pharmaceuticals Inc. bucked the trend, closing a $24 million Series C round led by Fidelity Biosciences, the life science venture arm of Fidelity Investments.

EnVivo President and CEO Kees Been said the money will be used to advance two products into the clinic, push three discovery programs into preclinical, and set aside some funds "in a war chest to in-license compounds that complement the pipeline." He expects the funding to last through late 2007 or early 2008.

EnVivo's lead product, an alpha 7-nicotinic acetylcholine receptor agonist for cognitive disorders such as Alzheimer's disease and schizophrenia, is in late preclinical development, which Been defines as the "clinical design and regulatory filing process." The compound is slated to begin Phase I trials before the end of the year. The study will be conducted in Europe, with an IND filing planned for 2007.

Although the alpha 7 program was in-licensed from Bayer HealthCare AG, the rest of EnVivo's pipeline derives from its core technology, which uses transgenic fruit flies to simulate neurodegenerative conditions including Alzheimer's, Parkinson's and Huntington's diseases.

"We start with the effect and then figure out the target," Been explained. Rather than "hypothesizing which targets to go after, we let the fruit flies tell us by feeding them compounds" and evaluating which "have a positive impact on disease."

Similar models have been created with mice, but the fruit flies require significantly less time, space and cost to work with. Additionally, EnVivo has developed a series of ex vivo and in vitro assays based on its fruit fly models, which it uses to screen libraries of compounds. Those screens have led the Watertown, Mass.-based company to four CNS programs - all with different targets and mechanism of action.

Most advanced is EVPK-0003546 for Huntington's disease, which is slated to begin Phase I trials in early 2007. The compound is an oral reformulation of an undisclosed generic drug that EnVivo identified when screening a library of generic compounds. Been declined to provide additional details regarding the mechanism or target, but said the company also has begun animal studies in a related program based on an analogue of that compound, which he hopes to see in preclinical studies next year.

Also slated for preclinical next year is EVP-0002442, a novel compound that has shown efficacy in EnVivo's animal models for neuroprotection in Alzheimer's and Huntington's diseases. The mechanism and target are confidential, but Been said the compound resulted from screening a focused library through EnVivo's proprietary assays.

The final program tagged for preclinical next year involves isotypic selective small-molecule histone deacetylase (HDAC) inhibitors for Huntington's disease. The compounds are being jointly developed with Montreal-based MethylGene Inc. (See BioWorld Today, July 14, 2004.)

EnVivo concurrently announced it added Jean-Marie Vallet, formerly of Guilford Pharmaceuticals Inc., as vice president of business development. Been said the company is "very serious about seeking a partner to develop the alpha 7 program and, more importantly, is looking for in-licensing opportunities in the CNS space."

EnVivo was founded in 2001 and employs 38 people. The company previously raised a $23 million Series B in 2004 and a $14.9 million Series A in 2002, both led by Fidelity Biosciences. Been noted that Fidelity is "an extremely committed investor to neurodegenerative diseases" even though the field is "a high-risk area."

Existing investors CoGene BioTech Ventures and the BBBC Investor Group, which includes Baylor College of Medicine, did not participate in the round, but several of EnVivo's original angel investors joined in.

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