SIFI, a leading international pharmaceutical company specializing in ophthalmology, is pleased to announce a scientific collaboration with the University of California, San Francisco ("UCSF") aimed at improving the management of Acanthamoeba Keratitis ("AK").

The Parasitic Ulcer Treatment Trial ("PUTT") is an investigator-initiated study led by Dr. Jeremy Keenan, Professor of Ophthalmology at UCSF, and performed at multiple sites across the United States of America, Brazil, India and the United Kingdom, with the objective of enrolling 232 patients. The primary objective of this multicenter, randomized controlled trial is to determine whether patients who start topical corticosteroids 1 month after beginning an anti-acanthamoebic regimen will have better visual acuity at 6 months compared to patients given a placebo eyedrop.

SIFI received a Marketing Authorization from the European Commission for Akantior® (polihexanide 0.08%) in August 2024 after over 15 years of research and development. Its approval was supported by the ODAK trial, the largest Phase 3 study ever conducted for AK, which demonstrated high cure rates and set a new standard of care. SIFI holds international patents on Akantior®, including the US application 2023/0263824.

The University of California, San Francisco (UCSF) is a world-renowned medical institution dedicated to research, education, and patient care. The UCSF Department of Ophthalmology is at the forefront of vision research and clinical innovation, working to improve treatment outcomes for rare and severe eye diseases.

Prof. Jeremy Keenan, Principal Investigator at UCSF, commented:

"The PUTT trial is designed to make an evidence-based contribution to an important debate in the management of AK: the use of adjunctive corticosteroid eyedrops alongside an effective antiamoebic treatment. AK is a rare but very severe ocular infection that can potentially lead to blindness and requires urgent treatment.  Using a high-concentration, more potent anti-amoebic eyedrop produced in accordance with pharmaceuticals' good manufacturing practices, instead of the lower concentrations typically ordered from compounding pharmacies, will allow us to more cleanly study the anti-inflammatory effect of adjunctive corticosteroid eyedrops, reducing variability arising from the use of compounded formulations across multiple clinical sites."

AKANTIOR (polihexanide 0.08%) is the first and only approved drug for the treatment of AK 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.

Fabrizio Chines, CEO of SIFI, added:

"At SIFI, patients always come first. We strive to improve access to our most effective treatment for AK worldwide. Whilst we continue our engagement with the FDA to submit a New Drug Application for Akantior® later this year, we are delighted to support Prof. Keenan and the other investigators of the PUTT trial with our proprietary GMP-grade Polihexanide 0.08%. It is great to see that the first patient in the US has received our drug, after many years of R&D investments. I also hope this is the beginning of fruitful collaborations in rare corneal infections, as we advance the clinical development of Polihexanide in Fungal Keratitis, following the Orphan Drug Designations received in the USA and Europe."

 

Source: prnewswire.com

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