Yo-Yo dieting without additional treatment can explain high placebo response rates in NASH clinical trials

Simulations Plus, Inc. (Nasdaq: SLP), a leading provider of modeling and simulation software and services for pharmaceutical safety and efficacy, today announced that it presented simulation results performed with the quantitative systems pharmacology model, NAFLDsym, to help explain the relatively high positive response rates in placebo cohorts. Numerous recent late-stage clinical trials for potential treatments of non-alcoholic steatohepatitis (NASH) have included relatively high positive response rates in the placebo cohorts, despite not being provided the actual treatments. The high rates of response in the placebo cohorts have confounded clinical scientists in the NASH community, and they have contributed to the termination of several promising treatment candidates.

Lisl Shoda, Director of Immunology and Principal Scientist from Simulations Plus, presented “Yo-Yo Dieting Predicted to Contribute to Fibrosis Score Reductions in Untreated (Placebo) Cohorts” at The Liver Meeting, the American Association for the Study of Liver Diseases annual conference. These simulation results highlight how small changes to diet patterns and patient behavior can lead to reductions in fibrosis scores, a key metric of efficacy for NASH treatments.

Scott Q Siler, CSO of the DILIsym Services division of Simulations Plus, said: “We have known for many years that weight loss provides improvement in many aspects of NASH, including fibrosis. Attrition of potential blockbuster treatments for NASH patients has been quite high, in large part because of the surprisingly high positive response rates in the placebo groups. Reducing the placebo response and attrition rates of these candidate treatments can get them to patients who need them. This new research from Dr. Shoda highlights how even periodic weight loss and gain – yo-yo dieting – can lead to reductions in fibrosis scores despite minimal changes to body weight. This insight can help NASH clinical scientists better understand the clinical trial results and should keep potential treatments on track to be delivered to patients in short order.”

About Simulations Plus, Inc.

Serving clients worldwide for 25 years, Simulations Plus, Inc., is a leading provider of modeling and simulation software and consulting services supporting drug discovery, development research, and regulatory submissions. We offer solutions that bridge machine learning, physiologically based pharmacokinetics, quantitative systems pharmacology/toxicology, and population PK/PD modeling approaches. Our technology is licensed and applied by major pharmaceutical, biotechnology, chemical, consumer goods companies, and regulatory agencies worldwide. For more information, visit our website at www.simulations-plus.com. Follow us on Twitter | Read our Environmental, Social, and Governance (ESG) Report.

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