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Exploristics and Exonate announce successful collaboration to enhance clinical trial study design using cloud-based simulation

March 12, 2024 – Clinical Trials – Exonate, Exploristics, clinical trials, cloud-based simulation

Exploristics’ cloud-based simulation platform KerusCloud used to enhance study design for Exonate’s upcoming phase 2b study following successful phase 1b/2a study

12 March 2024 — Cambridgeshire and Belfast, UK — Exploristics, a world-leading provider of biosimulation software and biostatistics services for designing, analysing and reporting clinical trials and real-world studies, and Exonate, a biotechnology company developing novel, non-invasive, small-molecule therapeutics for patients with retinal vascular diseases, today announced the completion of a successful collaboration to optimise the study design for Exonate’s upcoming phase 2b study for diabetic eye disease. The collaboration has supported ongoing development of Exonate’s lead candidate, EXN407, following a recent successful phase 1b/2a study in November.

Using Exploristics’ innovative study simulation software platform, KerusCloud, the companies established a more efficient, data-driven approach to study design and protocol development within Exonate’s clinical development programs in retinal vascular diseases. KerusCloud was successful in delivering valuable quantitative insights into the upcoming clinical study, enabling an enhanced study design that minimises the risks, costs and duration of the programme.

The phase 2b study is planned to initiate in 2024, following the successful completion of the company’s phase 1b/2a trial for EXN407. The study concluded that EXN407 met all pharmacokinetic and safety parameters, as well as showing encouraging signs of biological activity. For more information please see the press release issued on 5 March.

Aiden Flynn, CEO, Exploristics, said: “We are delighted to have had the opportunity to work with Exonate to harness KerusCloud’s powerful and realistic simulations to ensure that the company’s clinical trial was primed for success. Exonate recognised the need to implement a data-driven approach to optimise efficiency and minimise the risks of their proof-of-concept studies by using rational design to manage key uncertainties and challenges. We look forward to a continuation of the relationship as Exonate progresses to phase 2b clinical trials in 2024.”

Loic Lhuillier, COO, Exonate, commented: “We were pleased to partner with the Exploristics team on our trial design and statistical analysis, which has greatly contributed to the efficiency of the programme. KerusCloud allowed us to develop our study design to recognise the transformative potential of EXN407 whilst ensuring we account for and minimise any potential risks. We thank Aiden and the team for their collaborative model and expertise throughout this project.”

To stay up to date on the development process of Exonate’s retinal vascular disease treatments, visit: https://www.exonate.com/

About Exploristics

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

About KerusCloud

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). The synthetic data is 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 exploristics.com/keruscloud-platform-overview or read our case studies.

About Exonate

Exonate is a biotechnology company developing novel, non-invasive, small-molecule therapeutics for patients with retinal vascular diseases which may lead to vision loss. The company’s pipeline is built around inhibition of pro-angiogenic VEGF by influencing splice patterns, for the treatment of conditions that have the formation of new blood vessels as a significant contributor, such as wet Age-Related Macular Degeneration (wet AMD) and Diabetic Eye Disease. Developed to penetrate to the back of the eye, reach the retina and prevent growth of blood vessels, Exonate’s treatments for retinal diseases are being developed as eye drops, eliminating the need for monthly injections into the eye, laser surgery or use of steroids, without sacrificing potency or permeability. There is a large unmet market opportunity for a topical therapy for diabetic retinopathy and diabetic macular oedema that can treat the conditions earlier in the disease process. Exonate’s lead asset, EXN407, has the potential to be the first topical treatment for retinal vascular diseases, including diabetic retinopathy and diabetic macular oedema. EXN407 has shown encouraging signs of efficacy, alongside meeting all endpoints, in a phase 1b/2a trial in diabetic patients with retinal eye disease (diabetic macular oedema). The company is led by a highly experienced management team, and has a strong foundation of scientific expertise, with cross-disciplinary experience in medicine and drug development. For more information, visit the Exonate website.