CB4211 Phase 1 Clinical Trial Temporarily Suspended to Address Injection Site Reactions
MENLO PARK, CA, USAI November 05, 2018 I CohBar, Inc. (NASDAQ: CWBR), a clinical stage biotechnology company developing mitochondria based therapeutics (MBTs) to treat age-related diseases, announced today the Phase 1 clinical study of CB4211, its lead MBT candidate under development as a potential treatment for non-alcoholic steatohepatitis (NASH) and obesity, has been temporarily suspended in order to address mild injection site reactions that have been unexpectedly persistent.
“Patient safety is very important to us and is also the primary objective of our CB4211 Phase 1 clinical trial,” said Simon Allen, CohBar CEO. “While only mild adverse events have occurred in the study to date, we are taking the time to address these injection site reactions in order to reduce the risk of any safety or tolerability issues in the trial going forward. We continue to believe in the potential of this novel compound as a treatment for NASH and obesity, and the timely resolution of this issue is our top priority.”
“Mild injection site reactions are common in Phase 1 clinical studies of subcutaneously injected peptide drugs, and for most drugs they resolve quickly,” said Kenneth C. Cundy, PhD., CohBar CSO. “In general, what we have seen are persistent painless bumps that can be felt under the skin and in most cases would be otherwise undetectable. Information to date suggests that some of the CB4211 dose persists at the injection site. We have a plan to address this issue in the near term and are seeking regulatory feedback with the goal of resuming the clinical dosing of CB4211 as soon as possible.”
About CB4211
CohBar’s lead program is based on CB4211, a first-in-class mitochondria based therapeutic (MBT) that has demonstrated significant therapeutic potential in preclinical models of nonalcoholic steatohepatitis (NASH) and obesity. CB4211 is a novel and improved analog of MOTS-c, a naturally occurring mitochondrial-derived peptide (MDP) which was discovered in 2012 by CohBar founder Dr. Pinchas Cohen and his academic collaborators and has been shown to play a significant role in the regulation of metabolism. CB4211 entered a Phase 1a/b clinical trial in mid-2018, which includes a potential activity readout relevant to NASH and obesity. NASH has been estimated to affect as many as 12% of adults in the U.S., and there is currently no approved treatment for the disease.
About CohBar
CohBar (NASDAQ: CWBR) is a clinical stage biotechnology company focused on the research and development of mitochondria based therapeutics (MBTs), an emerging class of drugs for the treatment of age-related diseases. MBTs originate from the discovery by CohBar’s founders of a novel group of peptides within the mitochondrial genome which regulate metabolism and cell death, and whose biological activity declines with age. CohBar’s efforts focus on the development of these mitochondrial-derived peptides (MDPs) into clinically relevant MBTs that offer the potential to address a broad range of age-related diseases with underlying metabolic dysfunction, including nonalcoholic steatohepatitis (NASH), obesity, Type 2 diabetes, cancer, and cardiovascular and neurodegenerative diseases. To date, the company and its founders have discovered more than 100 MDPs. For additional company information, please visit www.cohbar.com.
SOURCE: CohBar
Post Views: 19
CB4211 Phase 1 Clinical Trial Temporarily Suspended to Address Injection Site Reactions
MENLO PARK, CA, USAI November 05, 2018 I CohBar, Inc. (NASDAQ: CWBR), a clinical stage biotechnology company developing mitochondria based therapeutics (MBTs) to treat age-related diseases, announced today the Phase 1 clinical study of CB4211, its lead MBT candidate under development as a potential treatment for non-alcoholic steatohepatitis (NASH) and obesity, has been temporarily suspended in order to address mild injection site reactions that have been unexpectedly persistent.
“Patient safety is very important to us and is also the primary objective of our CB4211 Phase 1 clinical trial,” said Simon Allen, CohBar CEO. “While only mild adverse events have occurred in the study to date, we are taking the time to address these injection site reactions in order to reduce the risk of any safety or tolerability issues in the trial going forward. We continue to believe in the potential of this novel compound as a treatment for NASH and obesity, and the timely resolution of this issue is our top priority.”
“Mild injection site reactions are common in Phase 1 clinical studies of subcutaneously injected peptide drugs, and for most drugs they resolve quickly,” said Kenneth C. Cundy, PhD., CohBar CSO. “In general, what we have seen are persistent painless bumps that can be felt under the skin and in most cases would be otherwise undetectable. Information to date suggests that some of the CB4211 dose persists at the injection site. We have a plan to address this issue in the near term and are seeking regulatory feedback with the goal of resuming the clinical dosing of CB4211 as soon as possible.”
About CB4211
CohBar’s lead program is based on CB4211, a first-in-class mitochondria based therapeutic (MBT) that has demonstrated significant therapeutic potential in preclinical models of nonalcoholic steatohepatitis (NASH) and obesity. CB4211 is a novel and improved analog of MOTS-c, a naturally occurring mitochondrial-derived peptide (MDP) which was discovered in 2012 by CohBar founder Dr. Pinchas Cohen and his academic collaborators and has been shown to play a significant role in the regulation of metabolism. CB4211 entered a Phase 1a/b clinical trial in mid-2018, which includes a potential activity readout relevant to NASH and obesity. NASH has been estimated to affect as many as 12% of adults in the U.S., and there is currently no approved treatment for the disease.
About CohBar
CohBar (NASDAQ: CWBR) is a clinical stage biotechnology company focused on the research and development of mitochondria based therapeutics (MBTs), an emerging class of drugs for the treatment of age-related diseases. MBTs originate from the discovery by CohBar’s founders of a novel group of peptides within the mitochondrial genome which regulate metabolism and cell death, and whose biological activity declines with age. CohBar’s efforts focus on the development of these mitochondrial-derived peptides (MDPs) into clinically relevant MBTs that offer the potential to address a broad range of age-related diseases with underlying metabolic dysfunction, including nonalcoholic steatohepatitis (NASH), obesity, Type 2 diabetes, cancer, and cardiovascular and neurodegenerative diseases. To date, the company and its founders have discovered more than 100 MDPs. For additional company information, please visit www.cohbar.com.
SOURCE: CohBar
Post Views: 19
