The phase I monthly sustained release implant study showed that the treatment, Debio 9902, was well tolerated after repeated doses up to 15mg/per month and there were no safety concerns. The phase IIa once-daily oral study for a treatment period of nine months showed that Debio 9902 was safe and effective in the treatment of moderate AD.
In a phase I study, healthy volunteers were administered once monthly subcutaneous injections of Debio 9902 SR implants up to 15mg. Sustained levels of Huperzine A, the active metabolite of Debio 9902, were observed up to four weeks and Debio 9902 was well tolerated.
“The continuous release of Debio 9902 SR implants provides a new treatment alternative with the potential for better tolerance through a progressive, steady release of the active compound, therefore increasing patient compliance and efficacy,” said David Wilkinson, MARC, Moorgreen Hospital, Southampton, England and principal investigator in the UK.