The study topline results expected in the second half of 2021.
CATANIA, Italy, Nov. 19, 2020 -- SIFI, a leading ophthalmic company, announced today that it has achieved the full enrollment of 135 patients with Acanthamoeba keratitis (AK) in its pivotal Phase III clinical trial (043/SI).
The full enrollment in the trial is an important milestone in addressing the huge 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 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," comments 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 a devastating acute eye infection presenting with unbearable pain and extreme light sensitivity. AK is an ultra-rare 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 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."
About polihexanide 0.08%
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.
About Acanthamoeba Keratitis (AK)
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.
The non-specific and highly aggressive clinical presentation of AK is difficult to diagnose and is severely disabling for patients. Patients can rarely work or lead normal lives until symptoms resolve. This means that appropriate and timely management is essential.
SIFI is a leading ophthalmic company, headquartered in Italy, focusing on eye care since 1935. SIFI develops, manufactures, and markets innovative therapeutic solutions for patients with ophthalmic conditions. SIFI is fully committed through its R&D to improve the quality of life of patients, exporting treatments to more than 20 countries worldwide with a direct presence in Italy, Spain, France, Romania, Mexico and Turkey.
For more information about the trial (NCT03274895) please visit clinicaltrials.gov
Cautionary Note on Forward-Looking Statements
This release contains forward-looking statements regarding our strategy, plans, and prospects, including statements regarding the development of the Company's product candidate polihexanide 0.08%, the potential safety and efficacy profile of our product candidates, and our clinical plans. These forward-looking statements include, but are not limited to, statements about our plans, objectives, representations, and contentions and are not historical facts and typically are identified by the use of terms such as "may," "should," "could," "expect," "plan," "anticipate," "believe," "estimate," "predict," "potential," "continue" and similar words, although some forward-looking statements are expressed differently. Our actual results may differ materially from those indicated in these forward-looking statements due to risks and uncertainties related to the continued progress and timing of our various no programs, including the enrollment and results from ongoing and potential future clinical trials for polihexanide 0.08%.