Exploristics is pleased to announce today a collaboration with ENA Respiratory using Exploristics’ innovative study simulation software platform KerusCloud to establish a more efficient data-driven approach to study design and protocol development of a Phase 2b study for ENA Respiratory’s INNA-051, a first-in-class, broad-spectrum, innate immunomodulator in development for the prophylaxis of complications associated with community-acquired respiratory viral infections. KerusCloud will deliver valuable quantitative insights to reduce the risks, costs and duration of the clinical programs.
CEO, Aiden Flynn, said “We are delighted to be working with ENA Respiratory to harness KerusCloud’s powerful and realistic simulations to inform these important projects and ensure that their clinical trials are primed for success. It is clear that ENA really value a more informed, data-driven approach to their development strategy and that their decision-making is underpinned by quality data.”
For more information on KerusCloud, please visit https://exploristics.com/keruscloud-platform-overview/ or read our case studies.
Ruth Tal-Singer, Medicine Development Leader of ENA Respiratory, said “We look forward to collaborating with Exploristics and using the KerusCloud platform to optimize the design of this critical phase 2b study. As this is an unprecedented approach to improving host response to different viral pathogens in a community infection setting, we wish to use simulations and scenario planning to inform data-driven decision making.”
For more information on ENA Respiratory, visit https://enarespiratory.com/.
KerusCloud is a revolutionary simulation-guided study design platform that ensures clinical trials are designed effectively to collect the right data, in the right patients, in the right way. Its use supports evidence-based design decisions to extensively de-risk real clinical studies, reducing development timelines, costs and patient burden. To do this, KerusCloud uses real clinical information to generate highly realistic synthetic data sets (virtual populations). These synthetic data are then used as the basis for generating high numbers of study simulations that accurately mimic the complexity of real clinical studies. This allows researchers to assess the performance of multiple study design and analysis scenarios in silico, in minutes and choose the best options for real studies, first time. For more information on KerusCloud, please visit https://exploristics.com/keruscloud-platform-overview/ or read our case studies.
Exploristics is a technology-enabled services company that transforms clinical development for life science organisations with unique proprietary software and biostatistics consultancy supporting the planning, design and analysis of clinical studies. For more information about Exploristics, visit www.exploristics.com or follow us on LinkedIn or Twitter.
About ENA Respiratory and INNA-051
ENA Respiratory Pty Ltd is a clinical-stage pharmaceutical company developing INNA-051, an intranasal innate immune modulator for the prevention of complications associated with respiratory viral infections in at-risk populations, including the elderly, those with chronic lung conditions and individuals with occupational risk (e.g., first responders, military or essential services personnel). The company is also developing its innate immune modulators as vaccine adjuvants.
INNA-051 is a potent TLR2/6 agonist that is delivered using a convenient nasal spray to target the preferential site of initial replication of viral respiratory infections. Fast-acting and inducing a durable biologic response supporting weekly administration, INNA-051 works by recruiting innate immune cells and priming epithelial cells of the nasal mucosa to respond more quickly to infections, rapidly eliminating viruses and other pathogens before they spread throughout the body. In preclinical studies, INNA-051 and close analogues were shown to be effective against multiple respiratory viruses, including SARS-CoV-2, influenza (H1N1 and seasonal H3N2), and rhinovirus. In a Phase 2a influenza challenge study, it has been shown to accelerate virus clearance and increase early influenza host responses and genes for proteins known to have direct antiviral effects against influenza. For more information on ENA Respiratory, visit https://enarespiratory.com/.