DILIsym Services Secures $1.5M NIH Grant to Advance DILI Simulation Platform Renasym and Reduce Drug Development Costs

VCBeat (WeChat Official Account: vcbeat) has learned that on January 17, DILIsym Services, a U.S.-based provider of simulation software and related consulting services for drug-induced liver injury (DILI), announced it had secured a $1.5 million project grant. This marks the second round of funding awarded to the company by the National Institutes of Health (NIH).

On July 23 last year, DILIsym Services received a $1.7 million project grant from the U.S. National Institutes of Health to establish Renasym, a simulation platform for drug-induced liver injury.

Drug-Induced Liver Injury (DILI) is one of the most important drug-related diseases and has become a major cause of pre-market drug registration failures, post-market safety warnings, and market withdrawals. Due to the wide variety of drugs that can cause liver injury and the fact that the same drug may result in different types of clinical liver damage in different individuals, its occurrence is often unpredictable. Drug-induced liver injury can range from mild elevations in transaminases to severe cases leading to liver failure. The associated public health and disease burden issues have increasingly drawn attention and concern.

Renasym, a drug-induced liver injury (DILI) simulation platform developed by Dilisym Services, establishes physiologically based pharmacokinetic (PBPK) models for specific drugs using the GastroPlus software. Pharmaceutical companies leverage this simulation platform during new drug development or generic drug research to rapidly screen and assess hepatic toxicity associated with different compounds, thereby reducing drug development costs.

Image source: Simulations Plus official website

Dilisym Services, founded in 2015 and headquartered in North Carolina, USA, is a subsidiary of Simulations Plus. With funding from the first round of grants awarded by the U.S. National Institutes of Health (NIH), Dilisym Services developed the first commercial version of Renasym. The second round of grant funding will support the company in further refining its platform. The final version of Renasym, a simulation platform for drug-induced liver injury (DILI), will be marketed to the entire pharmaceutical industry.

“We are delighted that the National Institutes of Health supports Dilisym Services’ mission to help the pharmaceutical industry modernize drug development and reduce the cost of developing new drugs,” said Dr. Brett Howell, President of Dilisym, in a statement.

Simulations Plus, Inc. was incorporated in California on July 17, 1996. The company is dedicated to the development and production of software for drug research and development and education, while also providing consulting and contract research services to the pharmaceutical industry. Simulations Plus’ software is utilized by major biopharmaceutical technology companies and drug research institutions worldwide. The company has driven innovations in the fields of medicinal chemistry, computational chemistry, pharmaceutical sciences, and biology.

The National Institutes of Health (NIH) is a biomedical research agency under the U.S. Department of Health and Human Services. It conducts its own scientific research through intramural programs and provides funding for biomedical research to non-NIH research institutions and companies through extramural programs. Some of the NIH’s scientific achievements include the discovery of fluoride for preventing tooth decay and the development of lithium therapy for treating bipolar disorder.