A novel investigational first-in-class drug called imeglimin (Poxel
Pharma) has shown promise in treating type 2 diabetes in a phase 3 study
conducted in Japan.
Findings from the Trials of Imeglimin for Efficacy and Safety (TIMES) clinical development program were presented September 18 during a symposium here at the European Association for the Study of Diabetes (EASD) 2019 Annual Meeting by Julie Dubourg, MD, Poxel's medical director of clinical development.
"In all phase 2 and phase 3 trials, imeglimin has demonstrated very robust efficacy in the type 2 diabetic population, as well as in subpopulations such as elderly patients and those with chronic kidney disease. The safety and tolerability profile is also very good. So this [may be] a new option for the treatment of patients with type 2 diabetes as mono- or add-on therapy," Dubourg told Medscape Medical News.
Imeglimin works by improving mitochondrial function, which in turn increases insulin secretion and insulin sensitivity in the muscle while also decreasing hepatic glucose production, Ralph A. DeFronzo, MD, professor of medicine and chief of the diabetes division at the University of Texas Health Sciences Center, San Antonio, said during the symposium.
Imeglimin is the first of what will be a new "glimin" class of glucose-lowering agents.
"These drugs actually correct three of the big problems that are present in our diabetic patients...It provides us with a new mechanism of action," DeFronzo said.
In addition, because preclinical data suggest that imeglimin also mobilizes fat in the liver, "this drug also has the potential to be used in [nonalcoholic steatohepatitis]," he noted.
Asked to comment, Harold E. Lebovitz, MD, professor of medicine at the State University of New York-Brooklyn, said: "The Japanese data are very impressive, but we don't know yet how other populations will respond to it."
"It is clearly a new class with unique mechanisms, but we have to define what that role is," he added.
Lebovitz, who conducted early studies on imeglimin but isn't involved in its development now, also pointed out that the drug could work in some patients for whom other classes of glucose-lowering agents might not be effective, or appropriate, such as those with kidney disease.
"Glucose-lowering drugs are not all for the same group of people...People with kidney disease are very sensitive and have a lot of hypoglycemia...Every drug is probably useful for a subset of patients because type 2 diabetes is not a single disease."
Findings from the Trials of Imeglimin for Efficacy and Safety (TIMES) clinical development program were presented September 18 during a symposium here at the European Association for the Study of Diabetes (EASD) 2019 Annual Meeting by Julie Dubourg, MD, Poxel's medical director of clinical development.
"In all phase 2 and phase 3 trials, imeglimin has demonstrated very robust efficacy in the type 2 diabetic population, as well as in subpopulations such as elderly patients and those with chronic kidney disease. The safety and tolerability profile is also very good. So this [may be] a new option for the treatment of patients with type 2 diabetes as mono- or add-on therapy," Dubourg told Medscape Medical News.
Imeglimin works by improving mitochondrial function, which in turn increases insulin secretion and insulin sensitivity in the muscle while also decreasing hepatic glucose production, Ralph A. DeFronzo, MD, professor of medicine and chief of the diabetes division at the University of Texas Health Sciences Center, San Antonio, said during the symposium.
Imeglimin is the first of what will be a new "glimin" class of glucose-lowering agents.
"These drugs actually correct three of the big problems that are present in our diabetic patients...It provides us with a new mechanism of action," DeFronzo said.
In addition, because preclinical data suggest that imeglimin also mobilizes fat in the liver, "this drug also has the potential to be used in [nonalcoholic steatohepatitis]," he noted.
Asked to comment, Harold E. Lebovitz, MD, professor of medicine at the State University of New York-Brooklyn, said: "The Japanese data are very impressive, but we don't know yet how other populations will respond to it."
"It is clearly a new class with unique mechanisms, but we have to define what that role is," he added.
Lebovitz, who conducted early studies on imeglimin but isn't involved in its development now, also pointed out that the drug could work in some patients for whom other classes of glucose-lowering agents might not be effective, or appropriate, such as those with kidney disease.
"Glucose-lowering drugs are not all for the same group of people...People with kidney disease are very sensitive and have a lot of hypoglycemia...Every drug is probably useful for a subset of patients because type 2 diabetes is not a single disease."
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