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

Exploristics, a world-leading provider of biosimulation software and biostatistics services for designing, analyzing, and reporting clinical trials and real-world studies, and Exonate Ltd., 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 optimize the study design for Exonate’s upcoming Phase IIb study for diabetic eye disease. The collaboration has supported the ongoing development of Exonate’s lead candidate, EXN407, following a recent successful Phase Ib/IIa 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 minimizes the risks, costs, and duration of the program.

The Phase IIb study is planned to initiate in 2024, following the successful completion of the Company’s 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. For more information, please see the press release issued on 5th 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 recognized the need to implement a data-driven approach to optimize efficiency and minimize 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 recognize the transformative potential of EXN407 whilst ensuring we account for and minimize 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/