Simulations Plus Software Will Model Lung Disease in Scleroderma

The effort will help predict responses to treatments for interstitial lung disease

Marisa Wexler, MS avatar

by Marisa Wexler, MS |

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SSc-ILD | Scleroderma News | illustration of the lungs

Simulations Plus has released software that aims to use advanced mathematical computer models to predict responses to therapy in people with interstitial lung disease associated with systemic sclerosis (SSc-ILD).

The company says the new software, called ILDsym version 1A, may help toward developing new therapies for people with interstitial lung disease (ILD).

“Finding treatments which reduce the progression of ILD in patients with systemic sclerosis (SSc) has proven challenging, with only two [U.S.-approved] drugs to date,” Zackary Kenz, PhD, senior scientist at Simulations Plus, said in a company press release.

“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,” Kenz said.

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SSc-ILD | Scleroderma News | illustration of the lungs

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Systemic sclerosis, or scleroderma, is marked by the abnormal accumulation of scar tissue in the skin and internal organs. ILD is a group of disorders characterized by scarring in the lungs, which can develop as a complication of SSc.

Normally, the lungs need to be stretchy and elastic, so they can expand to take in air, but scar tissue in them makes them too stiff, impairing breathing. The buildup of scar tissue and inflammation there also damages lung tissues, ultimately impairing their ability to absorb oxygen.

“Interstitial lung disease significantly worsens the prognosis for patients with SSc and increases their healthcare costs by roughly 50%,” Lisl Shoda, PhD, associate vice president and director of immunology at Simulations Plus, said.

The ILDsym software is part of the company’s DILIsym services, which use quantitative systems pharmacology modeling to predict the safety and effectiveness of potential therapies.

These models incorporate the underlying biochemical mechanisms of a specific disease, the predicted compound concentration at the target site (with the help of pharmacokinetic models), and the effects and mechanisms of action of a particular compound. Pharmacokinetics refers to the therapy’s movement into, through, and out of the body.

“These three key aspects all then combine together and allows us to assess the potential efficacy of a targeted compound,” Kenz said in a company webinar.

Basically, the ILDsym model uses advanced mathematical computer models to approximate the biological systems that drive disease in SSc‑ILD and to predict how these systems will change in response to a treatment.

The software features representations of key biological processes in ILD, including scarring, inflammation, and damage to different kinds of lung cells and across various lung regions.

The model also includes a virtual SSc-ILD population of more than 700 simulated patients with variability across key areas of ILD — from fibrosis rates to disease extent and progression rates — as well as data on key outcomes like lung imaging and measures of lung function.

Moreover, ILDsym also allows new targets to be added to the model and can also be used to “optimize clinical trial protocols, identify key hypotheses related to predicted responses to treatment, as well as look at combinations of treatments with different mechanisms of action,” Kenz said in the webinar.

“ILDsym and our scientific consulting expertise are positioned to support our clients in the development of novel treatments for SSc‑ILD,” Shoda said. “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.”