FX125L is the lead drug candidate in this class, while other BSCIs have been identified as back up molecules or as candidates for development as topical anti-inflammatory agents.
BSCIs are anti-inflammatory compounds with a mechanism of action that involves the selective interaction with a well-characterised receptor, resulting in a potent inhibition of inflammatory cell migration. The compounds are anticipated to have broad applicability in inflammatory diseases.
Reportedly, following the successful completion of the single ascending dose study in July 2009, a multiple ascending dose study in which FX125L was administered orally, once-daily in healthy subjects, was also conducted in the US.
The second phase I study confirmed the safety, tolerability and PK profile of FX125L and provided data consistent with an interaction of FX125L with its target receptor. Complete results of the study will be presented in a future scientific meeting.
Konstantinos Efthymiopoulos, CEO of Funxional, said: “The results of the multiple dose study were entirely consistent with those of the single dose study and confirmed the excellent drug-like profile of FX125L. We are now starting the preparation of the Phase II studies with FX125L in different inflammatory conditions and anticipate the initiation of these studies in the US and Europe in the second quarter of 2010.”