Recruitment in India progressed well, with 88 adult patients enrolled by the end of 2024. Following an interim analysis conducted in April, the Independent Data Monitoring Committee recommended continuing the study and expanding it to include ten adolescents. The first adolescent was included in November.

In parallel, the first patient in the Ethiopia study was enrolled in April, and 36 patients had been recruited by the end of the year.

Both studies are planned to be completed in 2025, with results expected to be available in early 2026.

The second site for the Phase II study in India was initiated at Rajendra Memorial Research Institute of Medical Sciences (RMRIMS) in Patna in August. By the end of 2023, 39 patients were enrolled across the two study sites and 17 patients had completed the study. In parallel, institutional ethics committee and regulatory approvals were obtained for the Phase II study in Ethiopia, where the study site initiation visit was conducted in February 2024. The first patient in Ethiopia is expected to be enrolled in Q1 2024.

The Phase I clinical study report was completed in August 2022, with the results supporting continuation to Phase II. All regulatory approvals for the Phase II study in India were received and the site initiation visit took place in November 2022. The first patient was enrolled in December 2022. In parallel, preparations continued for a separate Phase II clinical trial in Ethiopia, with enrolment expected to begin in early 2023.

A Phase I multiple ascending dose study of LXE408 was completed in September 2021, when the last visit of the last participant was completed. All results are expected in the first quarter of 2022. The compound showed good tolerability in Phase I, supporting the continuation of the clinical study to Phase II. Preparation is underway to initiate a Phase II study with participants with visceral leishmaniasis in India in 2022.