EnVivo Pharmaceuticals Presents Additional EVP-6124 Phase 2b Clinical Trial Results at the Clinical Trials on Alzheimer's Disease (CTAD) Meeting
EnVivo Pharmaceuticals, a company dedicated to developing a broad range of novel central nervous system (CNS) therapies, today presented pharmacokinetic and pharmacodynamic data along with the previously reported statistically significant clinical results from its Phase 2b clinical trial of EVP-6124, a novel alpha-7 agonist, in patients with Alzheimer's disease. The data were highlighted in an oral presentation at the 5th Clinical Trials on Alzheimer's Disease (CTAD) Meeting, being held in Monte Carlo, Monaco. New data presented today demonstrate a significant relationship (p=0.003) between EVP-6124 plasma concentrations and the probability of experiencing an improvement in cognition, as measured by the Alzheimer's Disease Assessment Scale-Cognitive subscale-13 (ADAS-Cog-13). Positive results from this Phase 2b trial were also presented in July 2012 during the Late Breaking Novel Therapeutics Session at the Alzheimer's Association International Conference (AAIC).
“The additional data from our Phase 2b trial presented today add to the positive results announced in July and continue to build the foundation for EVP-6124 as a driver of pro-cognitive effect and enhanced function in patients with Alzheimer's disease. This is particularly promising, given the lack of effective therapies and novel treatment options in development for this devastating disease,” said Kees Been, president and chief executive officer of EnVivo Pharmaceuticals. “We are planning to advance EVP-6124 into a Phase 3 clinical trial in schizophrenia this fall and another Phase 3 trial program in Alzheimer's disease in 2013. This continued progress positions EVP-6124 for potential patient impact and benefit and moves us toward our goal of becoming a fully integrated biotechnology company.”
The six-month, double-blind, placebo-controlled study enrolled 409 patients and evaluated three doses of EVP-6124 taken once per day - 0.3 mg, 1.0 mg and 2.0 mg - against placebo. Initial results demonstrated that the 2.0 mg dose of EVP-6124:
- Met both of the trial's primary endpoints, with statistically significant positive effects on cognition (p=0.0189), as measured by ADAS-Cog-13 and clinical function (p=0.0253), as measured by the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB);
- Showed statistically significant results across several secondary endpoints of other cognitive and clinical measures; and,
- Was generally safe and well-tolerated over the six-month dosing period for the trial.
“The addition of the pharmacokinetic and pharmacodynamic data from the Phase 2b trial demonstrate an important correlation between improved cognition and plasma levels of EVP-6124,” said Dana Hilt, M.D., senior vice president, clinical development and chief medical officer of EnVivo. “We look forward to advancing EVP-6124 into Phase 3 studies, as there remains a significant need for treatment options that enhance cognition and function with an improved safety profile over currently available therapies.”
About Alzheimer's Disease
Alzheimer's disease is a complex neurodegenerative disease that affects the brain. One in eight Americans over the age of 65, or approximately five million people, currently have Alzheimer's disease, and with the aging of the baby boomer generation, the total number is expected to nearly triple by 2030. Alzheimer's disease is the sixth-leading cause of death in the United States. Over time, the disease destroys large areas of the brain resulting in cellular loss and dysfunction, a gradual loss of memory, problems with reasoning or judgment, disorientation, difficulty in learning, loss of language skills and decline in the ability to perform routine tasks. People with Alzheimer's disease can also experience changes in their personalities and behavioral problems such as agitation, anxiety, delusions and hallucinations.
EnVivo Pharmaceuticals' lead compound, EVP-6124, is a selective, potent, brain penetrant, oral alpha-7 nicotinic agonist being developed as a long-term treatment to restore and improve cognitive function with sustained effect in Alzheimer's disease and schizophrenia. EVP-6124 offers a novel mechanism of action by enhancing synaptic transmission in the brain and acting as a co-agonist in combination with Acetylcholine (ACh) to enhance cognition. By sensitizing the alpha-7 receptor, EVP-6124 makes it possible for smaller amounts of naturally occurring ACh to be effective in activating the A7 receptor. This mechanism of action could potentially alleviate the undesirable side effects caused by other systemic compounds (for example, acetylcholinesterase inhibitors, or AChEIs), which are dose-limited by toxic side effects. EVP-6124 has also been shown to increase the levels of key neurotransmitters such as glutamate and dopamine in key brain areas, which may be linked to enhanced cognition, not only in Alzheimer's disease and schizophrenia, but in other diseases.
EnVivo announced positive topline data from its double-blind, placebo-controlled Phase 2b clinical trial of EVP-6124 in schizophrenia in May 2011 and presented a comprehensive analysis of these findings in December 2011. The company also announced and presented positive findings from another double-blind, placebo-controlled Phase 2b clinical trial of EVP-6124 in Alzheimer's disease in July and October 2012.
About EnVivo Pharmaceuticals
EnVivo Pharmaceuticals, Inc. and its subsidiaries (“EnVivo Pharmaceuticals” or “EnVivo”) are dedicated to discovering and developing small molecule therapeutics for disorders of the central nervous system (CNS). EnVivo Pharmaceuticals, Inc. is a biotech company located in Watertown, Mass. The company's focus is on building an integrated company and it is working to convert its broad pipeline into a range of CNS therapies that leverage novel mechanisms of action by altering the progression of disease and providing improvement in cognitive and overall function. EnVivo's lead product is an alpha-7 nicotinic acetylcholine receptor agonist that has successfully completed Phase 2b clinical trials in both schizophrenia and Alzheimer's disease. EnVivo's other development programs include an epigenetics program based on Histone Deacetylase inhibition (HDACi), a Gamma Secretase Modulator program and a potent and selective PDE10 inhibitor program. For more information about EnVivo, visit www.envivopharma.com.
Susan Heins, 864-286-9597