SIFI Announces Positive Topline Results of the Pivotal Phase III Study of Polihexanide for the Treatment of Acanthamoeba Keratitis

- Polihexanide 0,08% monotherapy met the primary endpoint of clinical resolution rate over a 12-month timeframe.

- SIFI will request accelerated assessment at the European Medicines Agency (EMA) and intends to file a Marketing Authorization Application (MAA) in the first half of 2022.

- Polihexanide would become the first approved drug for the treatment of Acanthamoeba Keratitis, a rare, sight-threatening parasitic eye infection.

CATANIA, Italy, Oct. 19, 2021 /PRNewswire/ -- SIFI, a leading international ophthalmic company, announced today that the pivotal Phase III study on polihexanide 0,08% monotherapy in adults and adolescents with Acanthamoeba keratitis (AK), met its primary endpoint of 'clinical resolution rate over a 12-month timeframe'. It also demonstrated an encouraging safety and tolerability profile. Based on these results, SIFI will request an accelerated assessment and plans to file a Marketing Authorisation Application (MAA) at the European Medicines Agency (EMA) for polihexanide 0,08% monotherapy under the Centralised Procedure for Orphan-Designated Medicinal Products in the first half of 2022.

The phase III readout is a milestone in addressing the huge unmet need for treating AK, a rare acute corneal parasitic infection that often leads to blindness and eye loss. With these trial results, polihexanide could become the first approved drug for the treatment of AK anywhere in the world. The development of polihexanide as a high-dose 0.08% monotherapy has taken 14 years to reach this point.

Professor John Dart, the trial's principal investigator and Honorary Clinical Professor at the Institute of Ophthalmology, University College London, stated, "This landmark trial of 135 patients represents a breakthrough in the management of AK. The trial showed that monotherapy with high-dose 0.08% polihexanide is likely to become the standard of care for patients devastated by AK." Professor Dart continued, "I'm particularly impressed by the very high clinical resolution rate which gives a high chance for the majority of patients with AK to have their vision and their quality of life back. These results also give, for the first time, a well-defined protocol to the physicians' community for the treatment of AK so that they are prepared for managing the increasing numbers of cases as well as the outbreaks that have occurred from time to time."

"The results of this trial mark a fundamental milestone in our efforts to bring polihexanide to AK patients," stated Fabrizio Chines, Chairman and CEO of SIFI. "Adequate treatment is a significant unmet clinical need for this severe parasitic corneal infection, as no treatment is currently licensed for AK in any country. The Phase III data give us clarity that monotherapy with polihexanide 0,08% will effectively address this unmet medical need. We look forward to submitting the regulatory filing to the European Medicines Agency in 2022 and advancing this much needed medicine one step closer to patients.  These results also give us confidence to start on the regulatory pathway in the US, where the Food & Drug Administration (FDA) already granted SIFI orphan drug designation in this disease. Finally, we extend our deepest gratitude to patients, caregivers, investigators, and study staff who participated in this phase III study and contributed to what we believe is an important medical advancement in the treatment of AK."

The trial was a randomized, assessor-masked, active-controlled, multi-center trial designed to evaluate the efficacy, safety, and tolerability of polihexanide 0,08% monotherapy compared to a combination of polihexanide 0,02% + propamidine 0,10%. Both treatment arms have used a novel standardized treatment protocol It is the first-ever Phase III study for an investigational medicine performed for AK. (ClinicalTrials.gov Identifier: NCT03274895).

SIFI is evaluating different options for the commercialization of polihexanide 0,08% globally, including potential out-license agreements outside its core markets.

ABOUT polihexanide: Polihexanide stands to become the first approved drug for the treatment of AK. It is an anti-infective polymer which acts on both the trophozoites and cysts of the protozoan Acanthamoeba. It is formulated as a 0.08% concentration which makes it possible to administer as monotherapy eye drops in single-dose containers. In contrast, current treatment protocols include various non-standardized unlicensed alternatives and usually involve combination therapy.

ABOUT AK: AK is a rare, acute, severe corneal infection caused by Acanthamoeba, a free-living amoeba. AK can lead to poor vision, potential blindness or even eye loss and often requires single or multiple corneal transplants. It affects people of all ages, most of whom are young or middle-aged soft contact lens wearers. Patients report unbearable pain and extreme light sensitivity and can rarely work or lead normal lives until symptoms resolve. The incidence of AK has been rapidly growing in recent years.

ABOUT SIFI: SIFI is a leading international 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.

Key Contact:
Jelle Kleijn
Global Head of Acanthamoeba Keratitis
+31 615643708
jelle.kleijn@sifigroup.com 

Sebastiano Giuffrida
Head of Clinical Development
+39 3357615356
sebastiano.giuffrida@sifigroup.com

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