Lhasa Limited is thrilled to announce the launch of Kaptis 2. Kaptis is an in silico solution that is supporting organisations to more efficiently evaluate compound carcinogenic potential, whilst building more ethical and environmentally friendly assessments.
“This release marks a significant milestone in fulfilling our long-term ambition of enabling chemical safety assessment based on new approach methodologies.” Commented Adrian Fowkes, PhD, Director of Science at Lhasa. “Increasingly, non-animal studies can provide sufficient evidence for safety assessments; however, risk assessors often face challenges. Challenges include, knowing which assay to run, how the data available can support a decision, and where the uncertainty lies. Utilising an adverse outcome pathway framework, Kaptis contextualises evidence, enabling confident decisions to be made by both assessors and reviewers.”
Building on the success of Kaptis to date, this latest update introduces new adverse outcome pathway (AOP) knowledge and experimental data, improving the scientific robustness of conclusions.
Another notable update is the ability to add experimental data, allowing for a more relevant, personalised and accurate weight of evidence assessment.
In response to valuable feedback, Kaptis now includes a separate module for carcinogenicity, outside of ICH S1, supporting the broader carcinogenicity assessment problem and reflecting Lhasa’s commitment to continuous improvement and member satisfaction.
Alongside supporting the broader carcinogenicity assessment use case, the latest version of Kaptis continues to support the efficient evaluation of compound carcinogenic potential, aligning with the ICH S1B(R1) guideline. Kaptis, combined with expert review, improves decision-making when identifying whether a full carcinogenicity animal study will add value, making an overall assessment faster, more cost-effective and more ethical. ICH S1 functionality has been improved and updated, with a particular focus on improving expert review experience, as recently discussed within the computational toxicology publication; Structuring expert review using AOPs: Enabling robust weight-of-evidence assessments for carcinogenicity under ICH S1B(R1).
Susanne Stalford, PhD – Lead author and Principal Scientist at Lhasa commented, in relation to the publication; “The case studies detailed within our recent paper show the value Kaptis brings to weight-of-evidence assessments, enabling scientifically robust, transparent and consistent outcomes. This forms the basis of a best practice for ICH S1B(R1), which will align industry and regulators when making regulatory decisions for pharmaceuticals.”
In addition to these enhancements, the latest update introduces a new interface that lays the foundations for future modules. Such as, skin sensitisation and developmental and reproductive toxicity (DART) assessments, expanding the scope of Kaptis beyond carcinogenicity.
On this topic, Adrian added, “Kaptis is a generalisable approach, and it is great to see how it can enhance ICH S1 and carcinogenicity assessments, whilst also being applied to range of other endpoints and use cases.”
Discuss with an expert how the latest version of Kaptis can improve the efficiency and consistency of carcinogenicity and ICH S1 assessments.
Updates discussed within this article will be presented at Eurotox 2024, within Leveraging NAMs to optimise and accelerate safety assessments for complex endpoints.