Dear Reader,

On behalf of the SINDOFO Consortium, we wish you a happy, healthy and successful 2023.

2022 was an eventful year for the project with a lot of achievements regarding the preparation of the SINDOFO clinical trial.

The Multiple Ascending Dose study as well as combo tox studies (in animals) of the drug combination (not part of the project, but necessary for the SINDOFO clinical trial design) were completed. In addition, the clinical study design for the SINDOFO trial was elaborated and the Draft Synopsis written.

The first in-person consortium annual meeting took place in CERMEL, Lambaréné, Gabon, back-to-back with PAMAfrica. More details can be found here.  Also, the project was presented to the EDCTP Malaria Oversight Committee and all queries raised by the committee were successfully resolved.

As part of risk minimization activities, the Consortium decided to conduct Part 1 of the clinical trial in one single site, namely CERMEL, Gabon. This will facilitate standardization of safety assessments and review of the safety information between the Sponsor, medical monitor, PI and sub-investigator. Part 2 will be conducted at all 4 sites. Overall, almost all trial-related activities were subdivided within the consortium partners; remaining tasks (e.g. Monitoring), that cannot be conducted by the partners, will be outsourced.

Regarding Capacity Building, all sites recruited PhD students; their registrations at the respective universities are ongoing.

We are looking forward to a much more successful year, with some training for PhDs, Post-Docs ,and Clinicians, as well as a planned start date for Part 1 in Q3.

Best wishes,

The SINDOFO Project Coordination Team.