FALLS CHURCH, VA, USA I October 17, 2024 I Response Pharmaceuticals, Inc., a clinical-stage company focused on weight management and metabolic health in high-risk populations, today announced the initiation of enrollment in a Phase 2 trial evaluating the company’s drug candidate, RDX-002, for post-GLP-1 weight rebound. The study is assessing the effect of RDX-002, an investigational first-in-class inhibitor of intestinal microsomal triglyceride transfer protein (iMTP), on post-prandial triglyceride levels as well as associated effects on weight and other cardiometabolic risk factors in individuals discontinuing the GLP-1 agonists, semaglutide or tirzepatide, for the treatment of obesity.
“There is a significant and growing unmet need in patients coming off GLP-1 agonists who rapidly regain much of the weight lost while on these drugs, which reverses the cardiometabolic benefits associated with their weight loss” said Eric Keller, Response Pharmaceuticals’ Founder and CEO. “In our initial studies in antipsychotic-induced weight gain (“AIWG”), RDX-002 has shown promise in counteracting weight gain associated with the use of common anti-psychotics with good initial tolerability. We are excited to evaluate its effect in this second and important weight management setting while we continue development for AIWG.”
“An emerging issue in the treatment of obesity is the regain of body weight and associated cardiometabolic risk factors that occurs when patients stop GLP-1 agonist treatment,” Professor Chris Packard, Institute of Cardiovascular and Medical Sciences, University of Glasgow stated. “A treatment such as RDX-002, may help to minimize this weight rebound and provide patients a ‘soft landing’ following GLP-1 agonist discontinuation.”
“Obesity is a chronic, complex disease associated with increased risk for significant cardiovascular and metabolic comorbidities including hyperlipidemia, insulin resistance, type 2 diabetes, hypertension, and cardiovascular disease,” Dr. Bill Sasiela, Chief Medical Officer noted. “While GLP-1 agonists such as semaglutide and tirzepatide have shown the ability to significantly reduce weight and the associated CV/metabolic risk factors in obesity, the vast majority of patients eventually discontinue these drugs. RDX-002 has shown promise in counteracting drug-induced weight gain by decreasing the absorption of dietary fats from the intestine, thereby reducing caloric intake. This results in improved levels of post-meal triglycerides, “bad” LDL-cholesterol, and glycemic control, all of which are established risk factors for developing cardiovascular disease and diabetes.”
The trial (NCT06640972) is a double-blind study evaluating the efficacy and tolerability of RDX-002 over 12 weeks in patients who have lost significant weight using GLP-1 agonist drugs but are planning to discontinue the treatment. Data from this study are expected in the second half of 2025.
Response is also pleased to announce that we will be presenting the results from our proof-of-concept study of RDX-002 in antipsychotic induced weight gain at Obesity Week 2024 in San Antonio on November 4th. See https://obesityweek.org for program and full details.
About RDX-002
RDX-002, Response Pharmaceuticals’ lead candidate, is an investigational first-in-class, potent, selective, and gut-specific small molecule inhibitor of intestinal microsomal triglyceride transfer protein (iMTP). The overall effect of iMTP inhibition is a decrease in the amount of triglycerides and cholesterol – and therefore calories – delivered to the body after a meal. RDX-002 is being developed as a therapy to combat drug-induced weight gain and improve cardiometabolic risk, including in patients taking life-saving anti-psychotic medications and those discontinuing GLP-1 agonists for the treatment of obesity. RDX-002 has been studied in multiple Phase 1 and Phase 2 clinical trials including 496 healthy subjects and patients dosed for up to 84 days. In these studies, RDX-002 lowered post-prandial triglyceride levels, circulating levels of low-density lipoprotein cholesterol (LDL-C), and reduced weight. RDX-002 was generally well-tolerated, with adverse events restricted to mostly mild to moderate GI effects. No serious adverse events have been attributed to RDX-002. RDX-002 is being developed under an exclusive world-wide license from Sanofi S.A.
About Response Pharmaceuticals
Response Pharmaceuticals is a clinical-stage biopharmaceutical company focused on developing treatments for weight management and metabolic health in high-need patient populations. The company is building its portfolio with an initial focus on helping those taking antipsychotic medications for disabling mental illnesses to combat weight gain and metabolic dysregulation associated with these treatments and accompanying elevated morbidity and mortality risk. Use in patients coming off weight loss drugs as well as potential other settings in which clinically significant weight gain and/or adverse metabolic changes are prevalent is also being explored.
For more information, please visit https://www.responsepharmaceuticals.com.
SOURCE: Response Pharmaceuticals
Post Views: 4,610
FALLS CHURCH, VA, USA I October 17, 2024 I Response Pharmaceuticals, Inc., a clinical-stage company focused on weight management and metabolic health in high-risk populations, today announced the initiation of enrollment in a Phase 2 trial evaluating the company’s drug candidate, RDX-002, for post-GLP-1 weight rebound. The study is assessing the effect of RDX-002, an investigational first-in-class inhibitor of intestinal microsomal triglyceride transfer protein (iMTP), on post-prandial triglyceride levels as well as associated effects on weight and other cardiometabolic risk factors in individuals discontinuing the GLP-1 agonists, semaglutide or tirzepatide, for the treatment of obesity.
“There is a significant and growing unmet need in patients coming off GLP-1 agonists who rapidly regain much of the weight lost while on these drugs, which reverses the cardiometabolic benefits associated with their weight loss” said Eric Keller, Response Pharmaceuticals’ Founder and CEO. “In our initial studies in antipsychotic-induced weight gain (“AIWG”), RDX-002 has shown promise in counteracting weight gain associated with the use of common anti-psychotics with good initial tolerability. We are excited to evaluate its effect in this second and important weight management setting while we continue development for AIWG.”
“An emerging issue in the treatment of obesity is the regain of body weight and associated cardiometabolic risk factors that occurs when patients stop GLP-1 agonist treatment,” Professor Chris Packard, Institute of Cardiovascular and Medical Sciences, University of Glasgow stated. “A treatment such as RDX-002, may help to minimize this weight rebound and provide patients a ‘soft landing’ following GLP-1 agonist discontinuation.”
“Obesity is a chronic, complex disease associated with increased risk for significant cardiovascular and metabolic comorbidities including hyperlipidemia, insulin resistance, type 2 diabetes, hypertension, and cardiovascular disease,” Dr. Bill Sasiela, Chief Medical Officer noted. “While GLP-1 agonists such as semaglutide and tirzepatide have shown the ability to significantly reduce weight and the associated CV/metabolic risk factors in obesity, the vast majority of patients eventually discontinue these drugs. RDX-002 has shown promise in counteracting drug-induced weight gain by decreasing the absorption of dietary fats from the intestine, thereby reducing caloric intake. This results in improved levels of post-meal triglycerides, “bad” LDL-cholesterol, and glycemic control, all of which are established risk factors for developing cardiovascular disease and diabetes.”
The trial (NCT06640972) is a double-blind study evaluating the efficacy and tolerability of RDX-002 over 12 weeks in patients who have lost significant weight using GLP-1 agonist drugs but are planning to discontinue the treatment. Data from this study are expected in the second half of 2025.
Response is also pleased to announce that we will be presenting the results from our proof-of-concept study of RDX-002 in antipsychotic induced weight gain at Obesity Week 2024 in San Antonio on November 4th. See https://obesityweek.org for program and full details.
About RDX-002
RDX-002, Response Pharmaceuticals’ lead candidate, is an investigational first-in-class, potent, selective, and gut-specific small molecule inhibitor of intestinal microsomal triglyceride transfer protein (iMTP). The overall effect of iMTP inhibition is a decrease in the amount of triglycerides and cholesterol – and therefore calories – delivered to the body after a meal. RDX-002 is being developed as a therapy to combat drug-induced weight gain and improve cardiometabolic risk, including in patients taking life-saving anti-psychotic medications and those discontinuing GLP-1 agonists for the treatment of obesity. RDX-002 has been studied in multiple Phase 1 and Phase 2 clinical trials including 496 healthy subjects and patients dosed for up to 84 days. In these studies, RDX-002 lowered post-prandial triglyceride levels, circulating levels of low-density lipoprotein cholesterol (LDL-C), and reduced weight. RDX-002 was generally well-tolerated, with adverse events restricted to mostly mild to moderate GI effects. No serious adverse events have been attributed to RDX-002. RDX-002 is being developed under an exclusive world-wide license from Sanofi S.A.
About Response Pharmaceuticals
Response Pharmaceuticals is a clinical-stage biopharmaceutical company focused on developing treatments for weight management and metabolic health in high-need patient populations. The company is building its portfolio with an initial focus on helping those taking antipsychotic medications for disabling mental illnesses to combat weight gain and metabolic dysregulation associated with these treatments and accompanying elevated morbidity and mortality risk. Use in patients coming off weight loss drugs as well as potential other settings in which clinically significant weight gain and/or adverse metabolic changes are prevalent is also being explored.
For more information, please visit https://www.responsepharmaceuticals.com.
SOURCE: Response Pharmaceuticals
Post Views: 4,610
