Cloud-based simulation enhances clinical trial study

Biosimulation software and biostatistics services provider Exploristics (Belfast) and biotech Exonate Ltd, a developer of non-invasive, small-molecule therapeutics for patients with retinal vascular diseases, have completed optimising the study design for an upcoming Phase IIb study for diabetic eye disease. The collaboration has supported ongoing development of Exonate’s lead candidate, EXN407, following a Phase Ib/IIa study in November.

Exploristics simulation software platform KerusCloud, established a more efficient, data-driven approach to study design and protocol within Exonate’s clinical development programs, delivering valuable quantitative insights into an upcoming Phase IIb study, planned to initiate in 2024, following the successful completion of the Phase Ib/IIa trial for EXN407. The study concluded that EXN407 met all pharmacokinetic and safety parameters, as well as showing encouraging signs of biological activity.

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 IIb 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.”

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