OrsoBio Secures $67M in Series B to Advance Mitochondrial Protonophore Portfolio for Obesity and Related Disorders

OrsoBio, Inc., a clinical-stage biopharmaceutical firm based in Menlo Park, California, has recently secured $67 million in an oversubscribed Series B financing round. The funding was spearheaded by Ascenta Capital and Woodline Partners LP, with continued investment from existing backers such as Samsara Biocapital, Longitude Capital, Enavate Sciences, NuevaBio, and Eli Lilly and Company. With this new influx of funding, OrsoBio plans to expedite the development of its mitochondrial protonophore portfolio aimed at treating obesity and related metabolic disorders. Additionally, Evan Rachlin, MD, Co-Founder and Managing Partner of Ascenta Capital, will now serve on OrsoBio's Board of Directors.

Obesity, which currently affects over 40% of adults in the United States, is a major risk factor for conditions like type 2 diabetes, cardiovascular disease, and metabolic dysfunction-associated steatohepatitis (MASH). The condition arises from an imbalance between caloric intake and energy expenditure, leading to an accumulation of excess fat. While glucagon-like peptide-1 receptor agonists (GLP-1 RAs) have brought significant advancements in weight management by curbing caloric intake, they also have drawbacks such as loss of lean muscle mass and decreased energy expenditure.

OrsoBio’s research focuses on mitochondrial protonophores, which have shown promise in increasing energy expenditure and could potentially complement the benefits offered by GLP-1 RAs. Preclinical studies conducted by OrsoBio demonstrated that their mitochondrial protonophores resulted in weight loss, preserved lean muscle mass, and improved insulin sensitivity. Furthermore, when combined with a GLP-1 RA, these treatments led to additional weight and fat loss without adversely affecting lean mass. The benefits persisted even after discontinuing the GLP-1 RA, provided that protonophore therapy was continued.

One of the company’s lead compounds, TLC-6740, is currently undergoing a 12-week Phase 1b clinical trial for patients with obesity. Previous Phase 1 trials in healthy subjects showed that TLC-6740 was safe, well-tolerated, and led to dose-dependent increases in energy expenditure, along with improved lipid profiles and markers of insulin resistance. OrsoBio plans to initiate further Phase 1b and Phase 2a studies of TLC-6740 in patients with obesity and type 2 diabetes, including those already on GLP-1 RA treatments, in the near future.

OrsoBio is also developing two additional mitochondrial protonophores, TLC-1180 and TLC-1235, which are currently undergoing IND-enabling studies and are expected to be ready by 2025. TLC-1180 is designed to be a potent, long-acting protonophore suitable for weekly administration, either orally or subcutaneously. TLC-1235 is a controlled-release mitochondrial protonophore (CRMP) that has demonstrated metabolic benefits across various models and species.

The company’s pipeline includes other innovative treatments as well. TLC-3595, an ACC2 inhibitor, is in a Phase 2a study targeting type 2 diabetes. Meanwhile, TLC-2716, a liver X receptor (LXR) inverse agonist, is in Phase 2a trials for treating severe hypertriglyceridemia and MASH.

In welcoming the new investors, Mani Subramanian, MD, PhD, CEO and Founder of OrsoBio, stated that the additional resources will enable the company to advance its portfolio of mitochondrial protonophores and other potential therapies aimed at reducing the burden of obesity and associated diseases. He emphasized that the future of obesity treatment would likely include GLP-1 RA-based combinations, and this new funding will help establish the scientific and clinical foundations necessary for their protonophores to be integral components of these future regimens.

Evan Rachlin, MD, added that OrsoBio’s innovative mechanisms have the potential to significantly enhance weight loss, improve metabolic functions, and maintain lean muscle mass, possibly complementing GLP-1 RA-based treatments and expanding their long-term health benefits. He expressed optimism about collaborating with OrsoBio’s team to bring these advanced treatments to patients.

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