EnVivo Pharmaceuticals

From NI July/August 2010

EnVivo received hefty support from its corporate parent, Fidelity Biosciences (undisclosed, but we believe it reached nine figures), allowing them to initiate 300+ patient Phase IIb trials for their nicotinic alpha7 lead, EVP-6124, in both schizophrenia and Alzheimer's. The Alzheimer's trial is as an adjunct to Aricept. EnVivo is also in Phase I with its lead HDAC inhibitor, EVP-0334, to be first directed at Alzheimer's. It is a once-daily oral drug, and thus far has appeared safe. En Vivo believes that it may have a structural, disease-modifying element to its effect. Their gamma-secretase modulator, which they would like to partner, shows benefit in animal models, and is now in GLP testing. EnVivo continues to look at inlicensing as a means of broadening their CNS pipeline, areas of interest include tau therapeutics and in diabetic neuropathy.

From NI January 2010

EnVivo partnered the Japanese rights to their nicotinic alpha7 lead, EVP-6124, with Mitsubishi, which leaves them the US and EU to partner if and when they can get the terms they want, which did not happen with the limited Phase IIa data on-hand. The enviable part of their position is that EnVivo will have the support of its sole owner, Fidelity, in putting together the resources necessary to run substantial Phase IIb programs in both schizophrenia and Alzheimer's. The Alzheimer's trial will be as an adjunct to Aricept, and will begin during spring 2010. The schizophrenia trial should begin imminently. EnVivo also is in the clinic with its lead HDAC inhibitor, EVP-0334, first directed at Alzheimer's. It is a once-daily oral drug, and thus far has been safe. En Vivo believes that it may have a structural, disease-modifying element to its effect. Their gamma-secretase modulator, which they would like to partner, shows benefit in animal models. All of these programs bear watching as potential partnership assets, but for the time being, EnVivo can move ahead on its own.

From NI January 2009

EnVivo is in an exceptionally strong position. Their nicotinic alpha7 lead was successful in a cognition biomarker trial, now they have to decide if they will partner it based on early efficacy data, or invest the resources necessary for a full Phase II. The latter is tempting, but the failure Targacept/AstraZeneca encountered in their schizophrenia trial is a reminder of the risks involved. EnVivo also is entering the clinic with its lead HDAC inhibitor, which will likely be first directed at Alzheimer's. They have two other amyloid-targeting programs in preclinical and discovery research, and a PDE10 inhibitor that could eventually be directed towards schizophreniform cognition. Where EnVivo enjoys particularly unusual good fortune for this era is in its ownership. EnVivo was started by Fidelity, and Fidelity recently bought out the other investors and provided another $65 million in funding. As opposed to other private companies whose original investors are looking for an exit, Fidelity wanted to own the whole thing. This means EnVivo has options in terms of partnering, and in terms of inlicensing another platform for development, a luxury enjoyed by few of its peers.