SIFI announced that it has achieved the full enrollment of 135 patients with Acanthamoeba keratitis (AK) in its pivotal phase 3 clinical trial (043/SI).
The full enrollment in the trial is an important milestone in addressing the unmet need for treating AK infections. It also paves the way for standardizing the treatment of a disease that potentially leads to blindness and eye loss.
This is a multicenter randomized, double-masked, and active-controlled phase 3 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 phase 3 study for an investigational medicine performed for AK.
“The completion of patients’ enrollment in this phase 3 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,” Fabrizio Chines, SIFI’s President and CEO, said in a company news release. “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 unbearable pain and extreme light sensitivity. AK is an ultra-rare condition with an incidence rate of 1 to 4 per million people per year. Its incidence has been growing rapidly in recent years. Adequate treatment is a significant unmet clinical need for this severe corneal infection. No single agent has yet proven to be effective against both the cysts and the trophozoites of Acanthamoeba. And no treatment is currently licensed for AK in any country. There are currently various empirical treatment paradigms used in different countries. This inconsistency of approaches could leave many patients with long-term poor outcomes.
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,” adds the trial’s coordinator Professor John Dart (Moorfields Eye Hospital and The University College London Institute of Ophthalmology, London, United Kingdom).
Juliette Vila Sinclair-Spence, an AK patient advocate, has first-hand experience of the severity of the disease and the devastating impact it has on the lives of patients. She says, “After going through this rare and very painful disease, it is incredible to see the first standardized protocol for treating Acanthamoeba keratitis. This will be an important milestone for AK warriors like me, as it might improve our quality of care and life; and last but not least, give us the feeling that we are being heard.”