OrsoBio to Present Preclinical Data on Mitochondrial Protonophore Portfolio in Models of Obesity at the American Diabetes Association's 85th Scientific Sessions
MENLO PARK, Calif.--(BUSINESS WIRE)--OrsoBio, Inc. ('OrsoBio' or 'the Company'), a clinical-stage biopharmaceutical company developing treatments for obesity and obesity-associated disorders, today announced new preclinical data being presented at the 85th Scientific Sessions of the American Diabetes Association (ADA) being held June 20-23, 2025, in Chicago, Ill. The Company will present three abstracts highlighting the efficacy of its mitochondrial protonophores to induce weight loss and provide glycemic benefits while preserving lean mass in diet-induced obese (DIO) mice. The studies demonstrate the potential of TLC-6740 and TLC-1180—as monotherapy and in combination with the glucagon-like peptide-1 (GLP-1) receptor agonist semaglutide—for both the induction and maintenance of weight loss following incretin treatment.
'The mechanism of our mitochondrial protonophores to increase energy expenditure complements that of incretins to enhance and sustain weight loss and provide additive metabolic benefits,' said Mani Subramanian, MD, PhD, Chief Executive Officer of OrsoBio. 'These preclinical findings mark an important step in fulfilling our mission to develop innovative, effective, oral therapies for obesity that preserve muscle and support cardiometabolic health.'
OrsoBio is advancing a pipeline of novel therapies targeting obesity through mechanistically distinct and complementary approaches. The Company's lead candidates include TLC-6740 and TLC-1180, both mitochondrial protonophores that promote weight loss by increasing energy expenditure. In addition, OrsoBio is developing TLC-3595, a selective inhibitor of acetyl-CoA carboxylase 2 (ACC2), designed to enhance fat oxidation.
"GLP-1 receptor agonists have transformed obesity treatment but are limited by gastrointestinal side effects and loss of muscle mass,' said Rob Myers, MD, Chief Medical Officer of OrsoBio. 'Our preclinical data show that our mitochondrial protonophores drive sustained, fat-selective weight loss and metabolic benefits when combined with or sequenced after GLP-1 receptor agonists. These findings support our ongoing Phase 1b study of TLC-6740 in combination with tirzepatide (NCT05822544)."
Poster information:
Sequential Combination of the Mitochondrial Protonophore TLC-6740 With Semaglutide Normalizes Body Weight and Preserves Lean Mass in DIO Mice
Abstract #1687-P Poster Session: Monday, June 23, 2025 (12:30 - 1:30 p.m. CT)
This preclinical study assessed TLC-6740 alone, in combination with low-dose semaglutide (sequential combination), and as maintenance therapy following semaglutide discontinuation in DIO mice. The sequential combination of TLC-6740 with low-dose semaglutide produced superior body weight and fat mass loss, and improved glycemic parameters compared with TLC-6740 alone and high-dose semaglutide. Initiating TLC-6740 after semaglutide discontinuation maintained body weight and fat mass loss, and glycemic benefits. These findings support evaluation of TLC-6740 in combination with incretins in people living with obesity; a 24-week combination study of TLC-6740 with tirzepatide is ongoing (NCT05822544).
De Novo or Sequential Combination of the Mitochondrial Protonophore TLC-1180 With Semaglutide Improves Weight Loss and Preserves Lean Mass in DIO Mice
Abstract #1694-P Poster Session: Monday, June 23, 2025 (12:30 - 1:30 p.m. CT)
This preclinical study evaluated the effects of TLC-1180 alone, in combination with semaglutide, and as a maintenance treatment following semaglutide discontinuation in DIO mice. As monotherapy, TLC-1180 demonstrated body weight and fat mass loss and preserved lean mass. Body weight and fat mass loss were amplified, and lean mass was preserved with TLC-1180 in combination with semaglutide. These benefits persisted when TLC-1180 was used as a maintenance treatment after semaglutide discontinuation. These data highlight the potential of TLC-1180 as monotherapy, in combination with incretins, or as maintenance therapy post incretin discontinuation in people living with obesity.
Novel Combination of a Mitochondrial Protonophore and an Acetyl-CoA Carboxylase 2 (ACC2) Inhibitor Causes Weight Loss and Preserves Lean Mass in Obese Mice
Abstract #1686-P Poster Session: Monday, June 23, 2025 (12:30 - 1:30 p.m. CT)
This preclinical study evaluated the effects of the mitochondrial protonophore, TLC-1180, and the ACC2 inhibitor, TLC-3595—as monotherapy and in combination—and semaglutide in DIO mice. TLC-3595 dose dependently reduced body weight, fat mass, and liver biochemistry while preserving lean mass in DIO mice. A combination of TLC-3595 with TLC-1180 had similar weight loss efficacy to semaglutide, but preserved lean mass. Taken together, these data suggest that the novel, all-oral, non-incretin combination of TLC-3595 and TLC-1180 may cause similar weight loss to incretins and may afford additional advantages, including improved weight loss quality and/or tolerability (e.g., reduced incidence of gastrointestinal adverse events).
About TLC-6740
TLC-6740 is a novel, oral, liver-targeted mitochondrial protonophore in development for the treatment of obesity and obesity-associated diseases, including diabetes and MASH. Based on active hepatic uptake and mitochondrial protonophore activity, TLC-6740 increases energy expenditure in hepatocytes, and is expected to have broad, systemic metabolic and cardiovascular benefits, including weight loss, improved insulin sensitivity, and as a treatment for MASH, and dyslipidemia. TLC-6740 is currently being evaluated in a Phase 1b clinical trial, as monotherapy and in combination with tirzepatide, in patients living with obesity (NCT05822544).
About TLC-1180
TLC-1180 is a novel, potent, long-acting mitochondrial protonophore that has been shown to increase energy expenditure in mice with diet-induced obesity (DIO). In preclinical studies of DIO mice, TLC-1180 induced weight loss, improved glucose control, and enhanced the efficacy of GLP-1 receptor agonists, both as a single agent and in combination with incretins. TLC-1180 is currently completing IND-enabling studies and a first-in-human study is expected to initiate in 2025.
About TLC-3595
TLC-3595 is a novel and selective ACC2 inhibitor designed to treat obesity and type 2 diabetes by increasing fatty acid oxidation (FAO), reducing ectopic lipid accumulation, and improving insulin sensitivity in skeletal muscle and liver. The compound may also have potential as a treatment for other conditions characterized by impaired FAO, including heart failure with preserved ejection fraction (HFpEF) and metabolic dysfunction-associated steatohepatitis (MASH).
About OrsoBio, Inc.
OrsoBio, Inc. is a privately held, clinical-stage biopharmaceutical company dedicated to developing therapies to treat obesity and obesity-associated disorders, including type 2 diabetes, MASH, and severe dyslipidemias. OrsoBio currently has four programs in clinical and preclinical development with first-in-class compounds that address central pathways in energy metabolism. For more information, please visit www.orsobio.com.
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OrsoBio to Present Preclinical Data on Mitochondrial Protonophore Portfolio in Models of Obesity at the American Diabetes Association's 85th Scientific Sessions
Data demonstrate the potential of TLC-6740 and TLC-1180 to induce weight loss while preserving lean mass, as monotherapy and in combination with an incretin, in obese mice MENLO PARK, Calif., June 20, 2025--(BUSINESS WIRE)--OrsoBio, Inc. ("OrsoBio" or "the Company"), a clinical-stage biopharmaceutical company developing treatments for obesity and obesity-associated disorders, today announced new preclinical data being presented at the 85th Scientific Sessions of the American Diabetes Association (ADA) being held June 20-23, 2025, in Chicago, Ill. The Company will present three abstracts highlighting the efficacy of its mitochondrial protonophores to induce weight loss and provide glycemic benefits while preserving lean mass in diet-induced obese (DIO) mice. The studies demonstrate the potential of TLC-6740 and TLC-1180—as monotherapy and in combination with the glucagon-like peptide-1 (GLP-1) receptor agonist semaglutide—for both the induction and maintenance of weight loss following incretin treatment. "The mechanism of our mitochondrial protonophores to increase energy expenditure complements that of incretins to enhance and sustain weight loss and provide additive metabolic benefits," said Mani Subramanian, MD, PhD, Chief Executive Officer of OrsoBio. "These preclinical findings mark an important step in fulfilling our mission to develop innovative, effective, oral therapies for obesity that preserve muscle and support cardiometabolic health." OrsoBio is advancing a pipeline of novel therapies targeting obesity through mechanistically distinct and complementary approaches. The Company's lead candidates include TLC-6740 and TLC-1180, both mitochondrial protonophores that promote weight loss by increasing energy expenditure. In addition, OrsoBio is developing TLC-3595, a selective inhibitor of acetyl-CoA carboxylase 2 (ACC2), designed to enhance fat oxidation. "GLP-1 receptor agonists have transformed obesity treatment but are limited by gastrointestinal side effects and loss of muscle mass," said Rob Myers, MD, Chief Medical Officer of OrsoBio. "Our preclinical data show that our mitochondrial protonophores drive sustained, fat-selective weight loss and metabolic benefits when combined with or sequenced after GLP-1 receptor agonists. These findings support our ongoing Phase 1b study of TLC-6740 in combination with tirzepatide (NCT05822544)." Poster information: Sequential Combination of the Mitochondrial Protonophore TLC-6740 With Semaglutide Normalizes Body Weight and Preserves Lean Mass in DIO MiceAbstract #1687-P Poster Session: Monday, June 23, 2025 (12:30 - 1:30 p.m. CT)This preclinical study assessed TLC-6740 alone, in combination with low-dose semaglutide (sequential combination), and as maintenance therapy following semaglutide discontinuation in DIO mice. The sequential combination of TLC-6740 with low-dose semaglutide produced superior body weight and fat mass loss, and improved glycemic parameters compared with TLC-6740 alone and high-dose semaglutide. Initiating TLC-6740 after semaglutide discontinuation maintained body weight and fat mass loss, and glycemic benefits. These findings support evaluation of TLC-6740 in combination with incretins in people living with obesity; a 24-week combination study of TLC-6740 with tirzepatide is ongoing (NCT05822544). De Novo or Sequential Combination of the Mitochondrial Protonophore TLC-1180 With Semaglutide Improves Weight Loss and Preserves Lean Mass in DIO MiceAbstract #1694-P Poster Session: Monday, June 23, 2025 (12:30 - 1:30 p.m. CT)This preclinical study evaluated the effects of TLC-1180 alone, in combination with semaglutide, and as a maintenance treatment following semaglutide discontinuation in DIO mice. As monotherapy, TLC-1180 demonstrated body weight and fat mass loss and preserved lean mass. Body weight and fat mass loss were amplified, and lean mass was preserved with TLC-1180 in combination with semaglutide. These benefits persisted when TLC-1180 was used as a maintenance treatment after semaglutide discontinuation. These data highlight the potential of TLC-1180 as monotherapy, in combination with incretins, or as maintenance therapy post incretin discontinuation in people living with obesity. Novel Combination of a Mitochondrial Protonophore and an Acetyl-CoA Carboxylase 2 (ACC2) Inhibitor Causes Weight Loss and Preserves Lean Mass in Obese MiceAbstract #1686-P Poster Session: Monday, June 23, 2025 (12:30 - 1:30 p.m. CT)This preclinical study evaluated the effects of the mitochondrial protonophore, TLC-1180, and the ACC2 inhibitor, TLC-3595—as monotherapy and in combination—and semaglutide in DIO mice. TLC-3595 dose dependently reduced body weight, fat mass, and liver biochemistry while preserving lean mass in DIO mice. A combination of TLC-3595 with TLC-1180 had similar weight loss efficacy to semaglutide, but preserved lean mass. Taken together, these data suggest that the novel, all-oral, non-incretin combination of TLC-3595 and TLC-1180 may cause similar weight loss to incretins and may afford additional advantages, including improved weight loss quality and/or tolerability (e.g., reduced incidence of gastrointestinal adverse events). About TLC-6740 TLC-6740 is a novel, oral, liver-targeted mitochondrial protonophore in development for the treatment of obesity and obesity-associated diseases, including diabetes and MASH. Based on active hepatic uptake and mitochondrial protonophore activity, TLC-6740 increases energy expenditure in hepatocytes, and is expected to have broad, systemic metabolic and cardiovascular benefits, including weight loss, improved insulin sensitivity, and as a treatment for MASH, and dyslipidemia. TLC-6740 is currently being evaluated in a Phase 1b clinical trial, as monotherapy and in combination with tirzepatide, in patients living with obesity (NCT05822544). About TLC-1180 TLC-1180 is a novel, potent, long-acting mitochondrial protonophore that has been shown to increase energy expenditure in mice with diet-induced obesity (DIO). In preclinical studies of DIO mice, TLC-1180 induced weight loss, improved glucose control, and enhanced the efficacy of GLP-1 receptor agonists, both as a single agent and in combination with incretins. TLC-1180 is currently completing IND-enabling studies and a first-in-human study is expected to initiate in 2025. About TLC-3595 TLC-3595 is a novel and selective ACC2 inhibitor designed to treat obesity and type 2 diabetes by increasing fatty acid oxidation (FAO), reducing ectopic lipid accumulation, and improving insulin sensitivity in skeletal muscle and liver. The compound may also have potential as a treatment for other conditions characterized by impaired FAO, including heart failure with preserved ejection fraction (HFpEF) and metabolic dysfunction-associated steatohepatitis (MASH). About OrsoBio, Inc. 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