Another important and significant milestone of the ODAK research project, aimed at developing a stable and safe formulation of polyhexanide (PHMB) and making available an effective pharmacological treatment for keratitis by Acanthamoebawas achieved.
The ODAK project achieved an important goal: the conclusion of the Phase I clinical trial with PHMB eye drops at concentrations of 0.08%; 0.06% and 0.04%. All three concentrations were well-tolerated in healthy volunteers, making it possible to choose, with sufficient certainty, one of the three eye drops tested in Phase I for the subsequent Phase III clinical trial in patients with keratitis by Acanthamoebarare and devastating eye disease.
The Phase I, three-arm controlled trial vs. placebo (NCT No. 02506257), was conducted at three centres in the Netherlands and Belgium and involved 90 healthy volunteers. Two different doses were used, simulating the more aggressive treatment approach normally used in patients with keratitis by Acanthamoeba1 drop every hour for 12 daily administrations in the first week and 1 drop every 2 hours for 6 daily administrations in the second week.
The primary variable of the study was the percentage of dose-limiting events (DLE) detected, these are defined as those adverse events that result in treatment discontinuation. No serious adverse events occurred during the Phase I study, only 5 enrolled subjects had a DLE (overall DLE of 5.6%), supporting the safety of the tested eye drops. The most frequently reported adverse events were conjunctival and/or corneal staining, pain after eye drops instillation and conjunctival hyperemia.
Antonino Asero, ODAK Project Director: "I am very proud to announce the positive results of the Phase I clinical trial in which the 'orphan' drug PHMB has been shown to be well-tolerated in healthy volunteers, and can therefore enter Phase III clinical trials with the aim of becoming the first drug in the class for the treatment of keratitis by Acanthamoeba".
The Phase I clinical trial received funding from the European Union (FP7/2017-2013) on the basis of Grant Agreement HEALTH-F5-2012 No. 305661 awarded to the ODAK Project.
SIFI is the Leader of the ODAK Project formed by a Consortium of six European Partners from Italy, the Netherlands, France and the UK.
Scientific questions on the ODAK Project can be addressed directly to antonino.asero@sifigroup.com
See the original article in English.
On the same subject:
Acanthamoeba keratitis and medical therapy
ODAK project: update
Dr. Carmelo Chines
Direttore responsabile
English 
Italian