insitro and Lilly Enter Strategic Agreements to Advance Novel Treatments for Metabolic Diseases

Agreements will support insitro’s IND-enabling studies for first set of pipeline programs from its machine learning-powered platform

New paradigm for biotech and pharma alliance reflects the convergence of multimodal data at scale, machine learning and the latest modalities for medicine

insitro, a machine learning-enabled drug discovery and development company, today announced the execution of three strategic agreements with Eli Lilly and Company (Lilly) focused on advancing potential new medicines for metabolic diseases, including metabolic dysfunction-associated steatotic liver disease (MASLD), based on targets identified by insitro using the company’s AI/ML-based platform.

Metabolic diseases, including MASLD, affect millions worldwide, yet effective treatment options remain limited. Current therapies primarily manage symptoms without addressing root causes. This collaboration aims to shift this paradigm by combining insitro's machine learning platforms, particularly directed at early biology discovery, with Lilly’s expertise in cutting-edge drug delivery and metabolic disease biology.

Under the first two agreements, insitro has an option to in-license proprietary, clinical stage, ternary N-acetylgalactosamine (GalNAc) delivery technology from Lilly that it will combine with two different small interfering ribonucleic acid (siRNA) molecules discovered and developed by insitro, each specifically directed toward a different target in the liver.

Under the third agreement, insitro and Lilly will collaborate to discover and develop an antibody for a third novel target for metabolic disease. As part of the collaboration, the companies will work together on the early preclinical development activities until development candidate nomination, when insitro will be responsible for all remaining development and commercialization.

“We are innovating not only in our biology discovery, but also how we partner with industry leaders like Lilly to accelerate our therapeutic programs toward the clinic,” said Daphne Koller, Ph.D., founder and CEO of insitro. “Our proprietary AI/ML platform, leveraging multimodal data at scale, computational power, and genetics, has identified several high-value targets with extensive support in human genetics and translatable models. These could help provide transformative impact for patients with metabolic disease by addressing it at its root, and bringing together the best of biotech and pharma skill sets accelerates our impact.”

Under these agreements, insitro will partner with Lilly Catalyze360-ExploR&D, a pillar of external innovation at Lilly that brings enterprise learning, scientific know-how, and best-in-class research and development capabilities to accelerate partner science. Across all agreements, insitro retains full global rights to its programs, with Lilly being eligible to receive potential milestones and royalties.

This alliance highlights insitro’s capabilities in leading target discovery and early development efforts and its commitment to accelerate these programs toward the clinic, including via partnership with leading organizations that have differentiated expertise.

About GalNAc

Ternary architectures of N-Acetylgalactosamine are used as targeting and internalizing ligands for investigational (and approved) oligonucleotide-based antisense and siRNA therapeutics, binding to asialoglycoprotein receptors expressed on the surface of hepatocytes in the liver.

About MASLD

MASLD is caused by a buildup of fat in the liver in people with diabetes, obesity, high blood pressure, or high cholesterol who drink little to no alcohol. MASLD is estimated to impact 100 million people in the U.S today[1]. The majority of people with MASLD are asymptomatic and go undiagnosed for many years, which leads to the development of cirrhosis and ultimately, liver failure. Today, there are no approved interventional treatments for MASLD, and it is often managed by diet and lifestyle changes. Metabolic liver diseases are difficult to treat because of their complex, multifactorial nature involving genetic, environmental, and lifestyle factors, which has made pinpointing effective therapeutic targets challenging. Metabolic diseases, including MASLD, affect millions worldwide, yet effective treatment options remain limited. Current therapies primarily manage symptoms without addressing root causes.

About insitro

insitro is a machine learning-enabled drug discovery and development company creating a new approach for target and drug discovery. We integrate multimodal data from human cohorts and cellular models with the power of AI and machine learning. insitro is uncovering genetic targets and new therapeutic hypotheses, leveraging human and cell data to increase the probability of success. These insights provide the starting point for discovering new molecules, which we either build with our in-house, AI-enabled drug discovery platforms or with partners that extend our impact. With more than $700 million in capital raised to date, insitro is building a "pipeline through platform" with a focus on metabolic disease, neurodegeneration and oncology. Approaching the clinic, insitro aims to deploy its AI models to run smaller, better powered trials, enrolling the patients who can benefit most. Learn more at insitro.com

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