ACI
SANT'ANTONIO, Italy,
July 22,
2024 /PRNewswire/ -- SIFI, a leading international
ophthalmic company headquartered in Italy, is pleased to announce that the
Committee for Orphan Medicinal Products (COMP) of the European
Medicine Agency (EMA) has issued a positive opinion concerning
Orphan Drug Designation (ODD) for polihexanide in the treatment of
fungal keratitis.
This designation follows the positive opinion of Committee for
Human Medicinal Products (CHMP) adopted in May and the COMP
positive opinion dated March 30 of
this year for the medicinal product AKANTIOR®
(polihexanide 0.08%) in the treatment of acanthamoeba keratitis.
SIFI expects to receive the decision of the European Commission
(EC) for marketing authorization in August.
Polihexanide received an ODD in fungal keratitis from the US
Food and Drug Administration (FDA) in February 2022.
Fungal keratitis, a severe infection of the cornea caused by
fungi such as Fusarium, Aspergillus, and Candida species, is a
significant cause of ocular morbidity and unilateral blindness
worldwide1. Although rare, this condition can lead to
substantial vision loss if not treated promptly. Currently, no
approved treatments exist for fungal keratitis in Europe, Japan, Asia,
and most other regions globally.
COMP's positive opinion concerning ODD for fungal keratitis is
based on SIFI's in vitro, ex vivo and in vivo studies on
standardized strains, demonstrating the efficacy of polihexanide
against the most recurring species in fungal keratitis, such as
Fusarium, Candida and Aspergillus. In vivo study were performed in
collaboration with Gazi University (Ankara, Turkey).
Additional studies on human ocular isolates are ongoing to
potentially confirm the efficacy of polihexanide in fungal
keratitis.
SIFI plans to initiate clinical trials in patients affected by
fungal keratitis in 2025. The company will seek Contract Research
Organization (CRO) pitches for a Phase II clinical trial in Q4
2024. SIFI will focus its clinical development program on two major
geographies, such as the USA and
Europe. A potential CRO partner
should demonstrate extensive experience in ophthalmology and rare
diseases, and a global presence.
"As we are preparing to launch AKANTIOR®
(polihexanide 0.08%) in acanthamoeba keratitis across Europe, this COMP positive opinion concerning
ODD for fungal keratitis reinforces our commitment to further
invest on polihexanide and develop it in such rare disease where
there is a high unmet medical need," said Fabrizio Chines, Chairman
and CEO of SIFI. "We are eager to advance into the clinical
development after encouraging preclinical data and double down on
our efforts to develop therapeutic solutions for ophthalmic rare
diseases."
ABOUT SIFI: SIFI is a leading international ophthalmic
company, headquartered in Italy,
featuring an integrated business model, from research &
development to manufacturing and commercialization both in
pharmaceutical and biomedical sectors. Since our foundation in
1935, our mission is to improve people's lives through meaningful
innovation in eye care. SIFI exports to more than 40 countries
worldwide with a direct presence in major European markets,
Mexico and, through joint
ventures, in China and the United
Arab Emirates. More information is available at
www.sifigroup.com.
ABOUT AKANTIOR®: AKANTIOR®
(polihexanide 0.08%) stands to become the first approved drug for
the treatment of acanthamoeba keratitis in the world. It is an
anti-amoebic polymer that acts on both the trophozoites and cysts
of the protozoan acanthamoeba. It is formulated at a 0.8mg/ml
(0.08%) concentration which makes it possible to administer as
monotherapy eye drops in single-dose containers. The EC and the FDA
granted SIFI Orphan Drug Designation in the treatment of
acanthamoeba keratitis. CHMP opinion was received in May, EC
decision is expected in August 2024.
In addition, COMP confirmed the designated orphan medicinal product
status at the time of marketing authorisation of Akantior
(polihexanide).
ABOUT FUNGAL KERATITIS: Fungal keratitis is a severe
corneal infection that often results in blindness and eye
loss. The disease is most prevalent in tropical and
subtropical climates. According to The Lancet, annual
global incidence of fungal keratitis is estimated at 1,051,787
cases, with the highest rates in Asia and Latin America. There are no
approved treatments for fungal keratitis in Europe, Japan, Asia
and almost anywhere else around the World. In addition to lack of
approved medical alternatives, the incidence of fungal keratitis
may be on the uptick due the global trend in general resistance to
anti-fungal therapeutics.
1. AAO Fungal Keratitis – Europe EPIDEMIOLOGY
Contact:
Sabrina Zappia
+39 3336999669
press@sifigroup.com
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