The MACA-PK study is a Phase I/IIa study, whose protocol has been optimized to study the safety, pharmacokinetics and pharmacodynamics of Macuneos in healthy volunteers in a Belgian clinical center in 2017, and then in patients suffering from dry AMD recruited in five ophthalmological centers in France and Belgium, in 2018. BIOPHYTIS has selected SGS Life Science Services to conduct this multicentric international clinical study.
SGS already successfully supported BIOPHYTIS in 2016 with the SARA-PK study of Sarconeos on Sarcopenia and currently supports BIOPHYTIS in its approaches to regulatory agencies, particularly in the U.S.
Stanislas Veillet, chief executive officer of BIOPHYTIS, said: “The protocol of the MACA-PK study has been optimized to evaluate the effect of Macuneos on the visual function of patients suffering from AMD, due to start in 2018. These elements will complete the safety data from the healthy volunteers that will have been gathered in 2017, as originally planned. These elements are key to launching the phase 2b MACA-INT study in the right conditions, which will start afterwards in the second half of 2018, but which we will have been preparing with the MACA-OBS observational study.” He added: “Our objective is to pursue the development of Macuneos until the demonstration of its clinical activity and the safety of its use on patients suffering from AMD, in order to then co-develop Macuneos after MACA-PK or MACA-INT, in 2018 at the earliest, with one or several partners capable of commercializing this drug.”