CHMP endorses SIFI's AKANTIOR® for acanthamoeba keratitis

ACI SANT'ANTONIO, Italy, May 31, 2024 – SIFI has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has expressed a favorable opinion on AKANTIOR® (polihexanide under its international non-proprietary name), recommending its approval for treating acanthamoeba keratitis, a rare and severe eye condition.

Significant Milestone in Ophthalmology

Fabrizio Chines, Chairman and CEO of SIFI, expressed enthusiasm about the positive opinion from CHMP, noting that AKANTIOR® could provide a crucial therapeutic option for patients with acanthamoeba keratitis. This condition can significantly impair daily life and, if left untreated, may necessitate corneal transplants or even eye removal. Chines highlighted AKANTIOR® as evidence of SIFI's longstanding commitment to innovative ophthalmic solutions, with the company's history of nearly 90 years in the field. He also noted the encouraging results from various early access programs involving over 180 patients across 12 countries, which demonstrated the drug’s safety and efficacy.

Next Steps for Approval

The CHMP’s positive recommendation will be reviewed by the European Commission (EC), which is anticipated to make a final decision on the marketing authorization (MA) for AKANTIOR® by August 2024. If approved, this decision will be applicable across all EU member states, Iceland, Liechtenstein, and Norway.

Clinical Trial Data

The CHMP’s positive opinion is grounded in robust data from SIFI’s development program, including a Phase 1 trial and a comprehensive Phase 3 study. The pivotal Phase 3 trial, identified as NCT03274895, was a randomized, multicenter, and double-blind study involving 135 participants with acanthamoeba keratitis. This trial assessed the effectiveness, safety, and tolerability of polihexanide at a 0.08% concentration compared to an active control over 12 months. The clinical resolution rate was 86.7%, with a median cure time of approximately four months. The results showed significant improvements in patients' vision and quality of life.

The Phase 1 trial, identified as NCT02506257, involved 90 healthy volunteers and examined various concentrations of polihexanide compared to a placebo. The trial concluded that polihexanide 0.08% displayed no significant adverse events compared to the placebo.

Expert Endorsement

Professor John Dart of Moorfields Eye Hospital and the University College of London, the principal investigator of the Phase 3 trial, emphasized the breakthrough nature of AKANTIOR® as the first licensed treatment for acanthamoeba keratitis. He predicted that AKANTIOR® would become the standard of care for this severe condition, citing its high cure rates of over 86% when used as a monotherapy.

Commercialization Plans

Following expected regulatory approval, AKANTIOR® will be marketed by SIFI in major European countries like France, Germany, Italy, Romania, Spain, the United Kingdom, and Turkey, covering a population of 430 million. Additionally, SIFI’s partner Avanzanite will distribute the drug in other European countries, addressing an extra 180 million people. The incidence of acanthamoeba keratitis is estimated at 1 to 4 patients per million inhabitants.

About SIFI

SIFI is an international ophthalmic company based in Italy, involved in research, development, manufacturing, and commercialization within the pharmaceutical and biomedical sectors since 1935. The company exports to over 40 countries and maintains a direct presence in major European markets, Mexico, China, and the UAE through joint ventures.

About AKANTIOR®

AKANTIOR® (polihexanide 0.08%) is poised to become the first approved drug specifically for acanthamoeba keratitis globally. It is formulated as an anti-amoebic polymer effective against both the trophozoites and cysts of acanthamoeba, available in single-dose containers for monotherapy. Unlike current treatments involving non-standardized combination therapies, AKANTIOR® offers a standardized and licensed solution. The EMA and the US FDA have granted it Orphan Drug Designation for this indication.

About Acanthamoeba Keratitis (AK)

Acanthamoeba keratitis is a severe, acute parasitic infection of the cornea, primarily affecting contact lens wearers. The condition, which is considered an ocular emergency, can lead to severe pain, light sensitivity, potential blindness, and even eye loss, often requiring corneal transplants.

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