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!