EnVivo Pharmaceuticals, a company dedicated to developing a broad range of novel central nervous system (CNS) therapies, announced that it recently initiated a Phase 1 clinical trial of EVP-0962, its potent and selective gamma secretase modulator (GSM), in healthy volunteers. The trial is a double-blind, ascending single and multiple dose study designed to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and food effect of EVP-0962. To date, EVP-0962 has shown promising activity in preclinical cellular and transgenic models of Alzheimer’s disease.
“This launch of our clinical studies of EVP-0962 marks an important step forward for the program as we continue to build upon our foundation of encouraging preclinical data,” said Dana C. Hilt, M.D., senior vice president, clinical development and chief medical officer of EnVivo. “In preclinical studies, EVP-0962 has demonstrated a significant reduction in amyloid plaques, which are believed to be a cause of Alzheimer’s disease, and reversed behavioral deficits. We are encouraged by these findings and believe that gamma secretase modulators like EVP-0962 could represent the next generation of novel, disease modifying treatments for patients with Alzheimer’s.”
EVP-0962 is a proprietary small molecule that has been shown to selectively modulate gamma secretase, a key enzyme involved in the processing of amyloid and its toxic AB1-42 peptide, which is a key component of amyloid plaques in the brain. In a one-year preclinical study in transgenic Alzheimer’s models, EVP-0962 reduced AB1-42 peptide levels, decreased amyloid plaque build up, reversed behavioral deficits and reduced brain inflammation associated with Alzheimer’s disease. These findings were presented at the Alzheimer’s Association 2010 International Conference on Alzheimer’s Disease (ICAD). As EVP-0962 is a selective GSM and does not inhibit other gamma secretase substrates required for normal function (such as Notch), it is believed that it could demonstrate efficacy comparable to gamma secretase inhibitors, but with a more attractive safety profile.
Date: June 26, 2011
Source: EnVivo Pharmaceuticals
Filed Under: Drug Discovery