OrsoBio Announces Exclusive License to Intellectual Property Relating to Mitochondrial Protonophores for the Treatment of Severe Metabolic Disorders

— $2.3 million SBIR grant from National Institute of Diabetes and Digestive and Kidney Diseases will fund preclinical development activities for novel compound TLC-1235 —


Palo Alto, Calif. – November 2, 2022 – OrsoBio, Inc., a clinical-stage biopharmaceutical company developing treatments for severe metabolic disorders, today announced that is 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.

“Our research in rodent and nonhuman primate models of NAFLD/NASH and type 2 diabetes has shown that a controlled-release formulation of the mitochondrial protonophore 2,4-dinitrophenol (DNP) is safe while offering consistent and profound systemic metabolic benefits across a spectrum of preclinical models of metabolic disease,” said Gerald Shulman, MD, PhD, MACP, MACE, FRCP, the George R. Cowgill Professor of Medicine and Professor of Cellular and Molecular Physiology at Yale School of Medicine, Co-Director of the Yale Diabetes Research Center, and scientific advisor to OrsoBio. “I look forward to the continued progress of TLC-1235 as OrsoBio unlocks the potential of this compound and better understands its mechanism of action in patients with severe metabolic disorders for which there are currently limited effective treatments.”

The SBIR grant will enable OrsoBio to advance TLC-1235 as a potential treatment to improve insulin sensitivity, NASH, and dyslipidemia in patients with severe lipodystrophies. Specifically, the funding will support initiation of IND-enabling activities, including synthesis of TLC-1235 and safety pharmacology and toxicology studies.

“TLC-1235 provides a novel approach to addressing insulin resistance, which is the root cause of several severe metabolic disorders,” said Rob Myers, MD, Chief Medical Officer of OrsoBio and Co-Principal Investigator on the SBIR grant. “This NIDDK funding is a recognition of the extensive research from the Shulman Lab that has elucidated the mechanism of action of TLC-1235 and enables us to advance the compound to clinical studies with a goal of improving outcomes in patients with lipodystrophies and other severe metabolic disorders.”

About TLC-1235
TLC-1235 is a novel, controlled-release mitochondrial protonophore that has been shown to be both safe and effective in extensive preclinical models. Based on this mechanism of action, TLC-1235 increases energy expenditure and is expected to have broad, systemic metabolic and cardiovascular benefits, including improved insulin sensitivity, NASH, dyslipidemia, and weight loss.

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 new breed of biotech investment fund focused on translating cutting-edge biology into new therapies to treat patients with unmet medical needs. Founded in 2016 by Srinivas Akkaraju, MD, PhD, our team of scientists, investors and entrepreneurs takes a long-term view to value creation across all stages of public and private life science companies. We believe in a collaborative, hands-on approach, working closely with entrepreneurs to harness exciting scientific advances and build leading companies. Samsara actively manages assets on behalf of endowments, foundations, and family offices. For more information, please visit www.samsaracap.com.


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