Simulations Plus Releases State-of-the-Art QSP Software for Interstitial Lung Disease

ILDsym will enable new software and services revenue by aiding development of therapies for the treatment of patients with ILD as a complication of systemic sclerosis

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 its DILIsym Services (DSS) division has released ILDsym™ version 1A, quantitative systems pharmacology (QSP) modeling software. The development effort leading up to this release was sponsored by a leading biotechnology company that has used ILDsym to inform planned clinical trial design.

Dr. Zackary Kenz, principal scientist, said: “Finding treatments which reduce the progression of ILD in patients with systemic sclerosis (SSc) has proven challenging, with only two FDA-approved drugs to date. We believe ILDsym can contribute to better understanding of underlying SSc-ILD disease mechanisms and improve patient outcomes by using the predictive power of software to accelerate treatment development, leading to new treatments or combinations of treatments which could halt or reverse ILD progression.”

Dr. Lisl Shoda, associate vice president, added: “Interstitial lung disease significantly worsens the prognosis for patients with SSc and increases their healthcare costs by roughly 50%. ILDsym and our scientific consulting expertise are positioned to support our clients in the development of novel treatments for SSc‑ILD. Further, because ILD is a complication common to multiple diseases, we are positioned to customize ILDsym, thereby expanding our ability to support treatment of ILD across a spectrum of diseases.”

Features of ILDsym v1A include:

• representation of key ILD elements, such as:
  • fibrosis, inflammation, alveolar epithelial and endothelial injury, and lung function tests
  • different regions of the lungs as illustrated by high resolution computed tomography (HRCT), including the normal alveolar parenchyma, regions of ground glass opacity (GGO) or reticular opacity (RO), and honeycombed (HC) regions
• a virtual SSc-ILD population (SimPops^®) of greater than 700 subjects with variability in disease extent and progression rates
• important biomarkers or endpoints, including:
  • Forced vital capacity (FVC)
  • Diffusing capacity of the lungs for carbon monoxide (DLCO)
  • High resolution computed tomography (HRCT) of the lungs
  • Extracellular matrix (ECM) lung levels and circulating biomarkers (e.g., KL-6)

Simulations Plus recently hosted a webinar introducing the mechanistic underpinnings of ILDsym and the exploration of treatments within SimPops. View the webinar here. Dr. Zackary Kenz will be presenting an ILDsym poster at AAPS 2022 PharmSci 360 (October 16-19; Boston, MA). Visit poster # M1330-11-62 to learn about ways ILDsym might support your programs.

ILDsym is applied within comprehensive consulting services on drug development decisions and is also available for licensing. Contact us to schedule a conversation today!

About Simulations Plus

Serving clients worldwide for more than 25 years, Simulations Plus is a leading provider in the biosimulation market providing 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, and regulatory agencies worldwide. For more information, visit our website at www.simulations-plus.com. Follow us on LinkedIn | Twitter | YouTube.

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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.

Contacts

Simulations Plus Investor Relations

Ms. Renee Bouche

661-723-7723

renee.bouche@simulations-plus.com

Hayden IR
Mr. Brian Siegel

346-396-8696

brian@haydenir.com