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Simulations Plus Presented Breakthrough Scientific Data at Top Liver Disease Conference
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Rhea-AI Summary
Simulations Plus (Nasdaq: SLP) presented findings at The Liver Meeting that connect yo-yo dieting to increased placebo response rates in clinical trials for non-alcoholic steatohepatitis (NASH). The research suggests that minor dietary changes can significantly reduce fibrosis scores, a critical measure for treatment efficacy. This insight could aid in addressing the perplexing high placebo response rates observed in numerous clinical trials, potentially improving the viability of various treatment candidates for NASH.
Positive
Presentation of valuable insights at The Liver Meeting that may enhance understanding of NASH clinical trials.
Findings could potentially lead to improved treatment outcomes for NASH patients by addressing high placebo responses.
Modeling and simulation research may strengthen SLP's position in pharmaceutical consulting.
Negative
High placebo response rates in NASH trials continue to challenge the approval of promising treatments, impacting investor confidence.
Attrition rates of potential blockbuster NASH treatments remain high due to the confusing results in clinical trials.
Yo-Yo dieting without additional treatment can explain high placebo response rates in NASH clinical trials
LANCASTER, Calif.--(BUSINESS WIRE)--
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.
Safe Harbor Statement Under the Private Securities Litigation Reform Act of 1995 – With the exception of historical information, the matters discussed in this press release are forward-looking statements that involve a number of risks and uncertainties. Words like “believe,” “expect” and “anticipate” mean that these are our best estimates as of this writing, but that there can be no assurances that expected or anticipated results or events will actually take place, so our actual future results could differ significantly from those statements. Factors that could cause or contribute to such differences include, but are not limited to: our ability to maintain our competitive advantages, acceptance of new software and improved versions of our existing software by our customers, the general economics of the pharmaceutical industry, our ability to finance growth, our ability to continue to attract and retain highly qualified technical staff, our ability to identify and close acquisitions on terms favorable to the Company, and a sustainable market. Further information on our risk factors is contained in our quarterly and annual reports and filed with the U.S. Securities and Exchange Commission.
What did Simulations Plus present at The Liver Meeting regarding NASH?
Simulations Plus presented findings linking yo-yo dieting to high placebo response rates in NASH clinical trials, suggesting that small dietary changes can reduce fibrosis scores.
How might the research presented by Simulations Plus affect NASH treatments?
The research could help reduce high placebo response rates in NASH trials, potentially improving the chances for treatment candidates to reach patients.
What is the significance of the findings from Simulations Plus for investors?
The findings may indicate improved understanding of clinical trial results, but ongoing high attrition rates for NASH treatments could affect investor confidence.
What challenges do NASH treatments face according to the Simulations Plus press release?
NASH treatments face challenges due to high placebo response rates observed in clinical trials, leading to the termination of several potential treatment candidates.
