Articles from OrsoBio, Inc.

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.

OrsoBio, Inc. (“OrsoBio” or “the Company”), a clinical-stage biopharmaceutical company developing treatments for obesity and obesity-associated disorders, together with a team of academic researchers from Europe, Japan, and the United States, published promising preclinical data regarding the potential of ACMSD inhibition in animal and cellular models of metabolic dysfunction-associated steatotic liver disease/steatohepatitis (MASLD/MASH). In addition to enhancing synthesis of NAD+, a key co-factor in diverse bodily processes, the researchers discovered that ACMSD inhibition prevents DNA damage and cellular redox stress, leading to significantly reduced inflammation and fibrosis due to MASH.

OrsoBio, Inc. ("OrsoBio” or “the Company”), a clinical-stage biopharmaceutical company developing treatments for obesity and obesity-associated disorders, today announced the close of an oversubscribed $67 million Series B financing. The financing was co-led by new investors Ascenta Capital and Woodline Partners LP, with significant participation from existing investors Samsara Biocapital, Longitude Capital, Enavate Sciences, NuevaBio, and Eli Lilly and Company. In conjunction with the financing, Evan Rachlin, MD, Co-Founder and Managing Partner of Ascenta Capital, has joined the OrsoBio Board of Directors. Proceeds from the financing will be used to accelerate development of the Company’s mitochondrial protonophore portfolio for the treatment of obesity and associated metabolic disorders.

OrsoBio, Inc., a clinical-stage biopharmaceutical company developing treatments for obesity and obesity-associated disorders, today announced new data for liver-targeted mitochondrial protonophore TLC-6740 being presented at the 84th Scientific Sessions of the American Diabetes Association being held June 21-24, 2024, in Orlando, Fla. The company will present three abstracts sharing new data demonstrating the safety and preliminary efficacy of its mitochondrial protonophore, TLC-6740, in healthy humans, and preclinical data highlighting weight loss driven by increased energy expenditure and improved glycemic control in mouse models following monotherapy and combinations with the selective ACC2 inhibitor, TLC-3595, and a GLP-1 receptor agonist.

OrsoBio, Inc. ("OrsoBio” or “the Company”), a clinical-stage biopharmaceutical company developing treatments for severe metabolic disorders, today announced the successful completion of a $60 million Series A financing, bringing the total capital raised by the Company to $97 million. The financing, which will support the advancement of OrsoBio’s obesity-focused portfolio, was co-led by Longitude Capital and Enavate Sciences. Existing investors Samsara BioCapital (“Samsara”) and NuevaBio, an affiliate of the founders, and new investor Eli Lilly and Company (NYSE: LLY) also participated in the round. Matthew Young of Longitude Capital and Edd Fleming, MD, of Enavate Sciences will join the OrsoBio Board of Directors, which includes Samsara representatives Srini Akkaraju, MD, PhD, and Cory Freedland, PhD.

OrsoBio, Inc., a clinical-stage biopharmaceutical company developing treatments for severe metabolic disorders, today announced initial safety, pharmacokinetic (PK), and pharmacodynamic data from its first-in-human, Phase 1 study of TLC-2716, a liver-targeted inverse agonist (inhibitor) of the Liver X Receptor (LXR). TLC-2716 is in clinical development as a potential treatment for severe hypertriglyceridemia (SHTG) and nonalcoholic steatohepatitis (NASH).

OrsoBio, Inc., a clinical-stage biopharmaceutical company developing treatments for severe metabolic disorders, today announced preliminary safety and pharmacokinetic (PK) data from the single ascending dose (SAD) portion of an ongoing Phase 1 trial of TLC-6740, a liver-targeted, mitochondrial protonophore. This study is exploring the safety and efficacy of TLC-6740 as an oral, first-in-class treatment for obesity and obesity-associated diseases, including diabetes and nonalcoholic steatohepatitis (NASH).

OrsoBio, Inc., a clinical-stage biopharmaceutical company developing treatments for severe metabolic disorders, today announced completion of the second cohort of subjects in an ongoing Phase 1 trial of TLC-6740, a liver-targeted mitochondrial protonophore. The first-in-human, Phase 1 study is exploring the safety and efficacy of TLC-6740 as an oral, first-in-class, liver-targeted mitochondrial protonophore for the treatment of obesity and obesity-associated diseases, including diabetes and nonalcoholic steatohepatitis (NASH).

OrsoBio, Inc., a clinical-stage biopharmaceutical company developing treatments for severe metabolic disorders, today announced that the first patient has been dosed in a Phase 2a clinical trial evaluating TLC-3595, a selective inhibitor of acetyl-CoA carboxylase 2 (ACC2). The trial aims to demonstrate the safety and insulin-sensitizing effects of TLC-3595 in patients with insulin resistance, including those with type 2 diabetes on approved glucose-lowering therapies. Proof-of-concept data supporting the safety and efficacy of TLC-3595 will be available by the end of 2023.

OrsoBio, Inc., a clinical-stage biopharmaceutical company developing treatments for severe metabolic disorders, today announced the presentation of five abstracts from the company’s programs at AASLD’s The Liver Meeting® from November 4-8. OrsoBio recently announced that it has acquired novel compounds and intellectual property for four programs addressing fundamental aspects of energy metabolism, including inhibitors of acetyl-CoA carboxylase-2 (ACC2), liver X receptor (LXR), and aminocarboxymuconate semialdehyde decarboxylase (ACMSD), as well as a portfolio of mitochondrial protonophores. These compounds have potential for the treatment of a range of metabolic diseases, including type 2 diabetes, severe dyslipidemias, lipodystrophies, and nonalcoholic steatohepatitis (NASH).

OrsoBio, Inc., a clinical-stage biopharmaceutical company developing treatments for severe metabolic disorders, today announced it has acquired exclusive worldwide rights to an ACC2 inhibitor program from Shionogi & Co., Ltd. The intellectual property includes lead candidate TLC-3595 (formerly S-723595), a novel and selective ACC2 inhibitor designed to treat type 2 diabetes by increasing fatty acid oxidation (FAO), reducing ectopic lipid accumulation, and improving insulin sensitivity in skeletal muscle and liver. TLC-3595 also has potential for treating other conditions characterized by impaired FAO, including cirrhosis with sarcopenia and genetic, long-chain FAO disorders.

OrsoBio, Inc., a clinical-stage biopharmaceutical company developing treatments for severe metabolic disorders, today announced its acquisition of assets relating to the Liver X Receptor (LXR) inverse agonist program from Phenex Pharmaceuticals, including lead candidate TLC-2716 and associated intellectual property. The company will present preclinical data describing the efficacy of TLC-2716 in dysmetabolic rodents and human liver organoids (HLOs) at AASLD’s The Liver Meeting®, as it continues a Phase 1, first-in-human study for which data are expected in early 2023.

OrsoBio, Inc., a clinical-stage biopharmaceutical company developing treatments for severe metabolic disorders, today announced its acquisition of an ACMSD inhibitor program from Mitobridge, an Astellas Company. The program includes a range of proprietary compounds being evaluated for their potential to address mitochondrial dysfunction in metabolic and inflammatory liver and kidney disorders.

OrsoBio, Inc., a clinical-stage biopharmaceutical company developing treatments for severe metabolic disorders, today announced that it has acquired exclusive worldwide rights to intellectual property from Yale University to enable the development of novel mitochondrial protonophores. Further, the company announced that it has secured a $2.3 million Small Business Innovation Research (SBIR) grant from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) to fund IND-enabling activities for its compound, TLC-1235, a controlled-release mitochondrial protonophore (CRMP) based on Yale intellectual property.

OrsoBio, Inc., a clinical-stage biopharmaceutical company developing treatments for severe metabolic disorders, today announced initiation of IND-enabling studies of TLC-6740, a liver-targeted mitochondrial protonophore. TLC-6740 will be initially advanced for the treatment of patients with severe lipodystrophies with a first-in-human study planned to initiate in 2023. Under the agreement with Gilead Sciences, initially signed in 2020, OrsoBio acquired TLC-6740 and an extensive library of mitochondrial protonophores, associated intellectual property, and a research license agreement with Yale University.

OrsoBio, Inc., a clinical-stage biopharmaceutical company developing treatments for severe metabolic disorders, today announced four development programs that target fundamental pathways of cellular energetics. OrsoBio is led by Chief Executive Officer, Mani Subramanian, MD, PhD, and Chief Medical Officer, Rob Myers, MD, who previously led the Liver Diseases Therapeutic Area at Gilead Sciences. The company was incubated by leading Bay Area-based venture capital firm Samsara BioCapital and builds upon the scientific work of Drs. Gerald Shulman (Yale University), Johan Auwerx (École Polytechnique Fédérale de Lausanne), and Takanori Takebe (Cincinnati Children’s Hospital Medical Center).