SIFI has achieved the full enrollment of 135 patients with Acanthamoeba keratitis (AK) in its pivotal Phase III clinical trial (043/SI).
This is a multi-center randomized, double-masked, and active-controlled Phase III trial designed to evaluate the efficacy, safety, and local tolerability of polihexanide 0.08% compared to a combination of polihexanide 0.02% and 0.1% propamidine – a commonly used empirical and unlicensed treatment. It is the first-ever Phase III study for an investigational medicine performed for AK.
"The completion of patients' enrollment in this Phase III trial marks an important milestone in the development of our Acanthamoeba keratitis' drug candidate and is the result of SIFI's long-standing commitment to reducing the burden of this infectious disease and improving patients' quality of life," said Fabrizio Chines, SIFI's President and CEO, who continues: "We expect to be reporting topline results in the second half of 2021 and we would like to thank all patients, investigators and clinical site coordinators who participated in this study."
AK is an acute eye infection presenting with pain and extreme light sensitivity. AK is a condition with an incidence rate of one to four per million people per year. Its incidence has been growing rapidly in recent years. Adequate treatment is an unmet clinical need for this corneal infection. No single agent has yet proven to be effective against both the cysts and the trophozoites of Acanthamoeba. There are currently various empirical treatment paradigms used in different countries. This inconsistency of approaches could leave many patients with long-term poor outcomes.
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Polihexanide 0.08% has already been granted orphan drug designation in both the European Union and United States. It has taken 13 years for the development process of polihexanide 0.08% to reach this point. Notably, if approved, it will become the first medicine to be licensed for AK globally.
"This study can be expected to provide both the first licensed therapy and an evaluated protocol for the delivery of treatment for this devastating condition for which, to date, only empirical treatments and protocols have been the standard of care," trial's coordinator Professor John Dart (Moorfields Eye Hospital and The University College London Institute of Ophthalmology, London, United Kingdom) said.
Polihexanide 0.08% is an investigational disinfectant, a polymer, in development for the treatment of AK. It acts on both the trophozoites and cysts of the protozoan Acanthamoeba. It is locally administered as a high-dose monotherapy, unlike current unlicensed alternatives which usually involve combination therapy with multiple eye-drop medications.
AK is a severe corneal infection caused by Acanthamoeba. It tends to be poorly treated with very high morbidity. AK potentially leads to poor vision, corneal transplant, blindness, or even eye loss. It affects people of all ages, most of whom are young and middle-aged soft contact lens wearers. AK can also occur in agricultural workers, or because of corneal trauma.