EnVivo grabs Alzheimer's spotlight with promising PhIIb results

EnVivo's strategy of targeting a nicotine receptor as a way of improving the thinking ability of patients with Alzheimer's produced some promising results in a closely-watched mid-stage study. Investigators for the biotech say that the Phase IIb trial hit a pair of primary endpoints, with the highest dose of the therapy improving cognition and patient function compared to the placebo arm.

Investigators enrolled about 400 patients with mild to moderate cases of the memory-wasting ailment for the study. One arm was offered a 2 mg dose of EVP-6124 over 23 weeks. The positive data for that group lays the foundation for a Phase III study in 2013 and is also likely to improve the biotech's shot at a partnership as it pursues a plan to transition to commercialization--provided it can win approvals in one of the toughest fields in drug development.

EnVivo, which is based in Watertown, MA, is pursuing a new approach in Alzheimer's. As Big Pharma companies like Johnson & Johnson ($JNJ), Pfizer ($PFE), and Eli Lilly ($LLY) are readying late-stage data on drugs that eliminate toxic levels of amyloid in the brain, EnVivo is targeting nicotinic A7 receptors specifically to ameliorate symptoms of the disease. Just as nicotine can stimulate learning and memory, EnVivo believes it can do the same thing with its lead program, but without the lethal side effects associated with smoking.

With little currently available to help millions of patients, EnVivo is targeting an enormous market. But as Medivation ($MDVN) proved with Dimebon, which also promised to address symptoms, the perplexing disease is also an extraordinarily high-risk target.

"These data continue to support our understanding of EVP-6124's novel mechanism and its development as a potential treatment for Alzheimer's disease and schizophrenia," said Dana Hilt, M.D., senior vice president, clinical development and chief medical officer of EnVivo. "In all of the studies we've conducted evaluating EVP-6124 to-date, we have seen pro-cognitive dose-dependent effects and we believe the novel mechanism has the potential to alleviate the undesirable side effects caused by other systemic compounds - for example, acetylcholinesterase inhibitors - which are dose-limited by side effects. We are extremely pleased with these results and look forward to initiating a Phase 3 trial next year."

EnVivo CEO Kees Been told Bloomberg that the company will need partners. "The world is very large, and too big for us on our own." 

- read the press release
- here's the Bloomberg report

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