OrsoBio Launches to Develop Novel Therapies for Patients with Severe Metabolic Disorders

— Company advances two clinical and two preclinical programs targeting fundamental

aspects of energy metabolism —


Palo Alto, Calif. – November 1, 2022 – 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).

OrsoBio’s programs, which include novel compounds and extensive intellectual property, were acquired from Gilead Sciences, Yale University, Shionogi, Phenex Pharmaceuticals, and Mitobridge, an Astellas company. OrsoBio has initiated preclinical and clinical activities to support advancement of these compounds for the treatment of patients with severe metabolic disorders, including diabetes, severe dyslipidemias, lipodystrophies, and nonalcoholic steatohepatitis (NASH).

“Our programs address the root causes of metabolic dysregulation in patients with severe metabolic disorders,” said Mani Subramanian, MD, PhD, Founder and CEO of OrsoBio. “Our first-in-class compounds have the potential to restore energy homeostasis and transform the care of patients with metabolic diseases that afflict millions of people globally.”

“OrsoBio has brought together the best scientific and clinical development minds in metabolism and assembled a cohesive team with deep expertise to execute on multiple programs in parallel,” said Srini Akkaraju, MD, PhD, Founding Managing Partner of Samsara BioCapital. “The OrsoBio approach of targeting multiple fundamental aspects of cellular energetics addresses large unmet patient need in severe metabolic diseases.”

The company’s pipeline consists of two clinical and two preclinical programs:

  • TLC-3595: Phase 2a-ready, selective inhibitor of Acetyl-CoA Carboxylase 2 (ACC2) for the treatment of diabetes and other disorders of impaired fatty acid oxidation (in-licensed from Shionogi & Co., Ltd)
  • TLC-2716: Liver-targeted inverse agonist of the Liver X Receptor (LXR) for the treatment of severe hypertriglyceridemia, familial hypercholesterolemia, and NASH, currently in Phase 1 (acquired from Phenex Pharmaceuticals)
  • Mitochondrial protonophores: TLC-6740, a liver-targeted mitochondrial protonophore (acquired from Gilead Sciences), and TLC-1235, a controlled-release mitochondrial protonophore (licensed from Yale University), to increase energy expenditure in patients with severe lipodystrophies and other metabolic disorders (both pre-IND)
  • Aminocarboxymuconate semialdehyde decarboxylase (ACMSD) inhibitor program: ACMSD inhibitors to increase the de novo synthesis of NAD+ from tryptophan and improve mitochondrial function in patients with metabolic and inflammatory liver and kidney disorders (acquired from Mitobridge, an Astellas company)

OrsoBio is leveraging a novel, human liver organoid (HLO) platform innovated by Dr. Takanori Takebe to optimize development of its compounds and expand upon its understanding of disease biology and its therapeutic candidates.

The company will share data on its programs, including the HLO platform, at The Liver Meeting®, hosted by the American Association for the Study of Liver Diseases, in Washington, D.C., November 4-8, 2022.

About OrsoBio, Inc.

OrsoBio, Inc. is a privately held, clinical-stage biopharmaceutical company dedicated to developing therapies to treat severe metabolic disorders, including type 2 diabetes, severe dyslipidemias, lipodystrophies, and nonalcoholic steatohepatitis. The company was co-founded by Mani Subramanian, MD, PhD, former Therapeutic Area Head for Liver Diseases at Gilead Sciences, and Samsara BioCapital. 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.

About Samsara BioCapital

Samsara BioCapital is a leading biotech investment firm focused on identifying opportunities across public and private markets. Samsara invests across the full spectrum of biotech opportunities from early-stage start-up to late-stage clinical assets. Our primary goal is to focus on finding and advising companies that will have significant impact on patients and address high unmet medical needs. Samsara works with entrepreneurs and top tier management teams that they believe will have meaningful impact on innovative therapeutics. The Samsara team has deep expertise in biotech with significant experience working together prior to founding the firm. The team is led by Srini Akkaraju who has over twenty-two years of industry experience and an MD, PhD in Immunology from Stanford University.


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Gwen Gordon

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OrsoBio team members collaborated with Professor Takebe in his pioneering study in Cell on the first use of en masse human liver organoids to define the genetic basis of metabolic liver disease and potential for tailored therapeutic development.