Another important and significant milestone of the ODAK research project, aimed in developing a stable and safe formulation of PHMB and providing an effective drug treatment for Acanthamoeba keratitis, has been achieved.
ODAK project has reached an important target: the conclusion of Phase I clinical trial of three polihexanide (PHMB) eye drops concentrations (0.08%, 0.06% and 0.04%). All the three concentrations are well tolerated in healthy volunteers allowing to select one of these eye drops to be tested through the Phase III clinical trial in patients with Acanthamoeba keratitis, a rare and devastating ocular disease.
Phase I was a 3-arm placebo-controlled study conducted in 3 Centers located in Nederland and Belgium. A total of 90 subjects were assigned to one of the four treatment groups: 1) 0.04% PHMB; 2) 0.06% PHMB; 3) 0.08% PHMB; 4) placebo. Two dosing frequency were used mimicking the most aggressive therapeutic approach normally adopted in patients with Acanthamoeba keratitis : 1 drop every hour/12 administrations in a day for 1 week and 1 drop every 2 hours/6 administrations in a day for a week.
The primary safety variable of the study was the rate of dose-limiting-events (DLE), defined as all adverse events causing interruption of the study drug, in each treatment arm. During the study no Serious Adverse Events occurred and only 5 subjects enrolled had a DLE (global DLE rate=5.6%).No DLEs occurred in the group treated with placebo and 0.04% PHMB; two DLEs occurred in the group treated with 0.06% PHMB and three DLEs in the group treated with 0.08% PHMB. The events causing the withdrawn from the study were all ocular and of mild to moderate intensity. The most frequent AEs reported were conjunctival staining, corneal staining, pain after instillation and conjunctival hyperemia.
Antonino Asero, ODAK Project Director: “I am very proud to announce the positive results of ODAK Phase I clinical trial in which the orphan drug PHMB has been shown to be safe in healthy volunteers, and may move forward to the Phase III clinical trial with the aim to become the first in class drug for the treatment of Acanthamoeba keratitis”
Phase I study has received funding from the European Union (FP7/2017-2013) under the Project ODAK Grant Agreement HEALTH-F5-2012 n°305661. SIFI leads the ODAK Project that involves a Consortium of six European Partners located in Italy, Nederland, France and United Kingdom.
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For further details read also:
Acanthamoeba keratitis: progress in the drug therapy
Progetto ODAK: update