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Altamira Therapeutics Announces European Patent Office Decision to Grant for Patent Application Covering Intranasal Betahistine

Published 10/11/2023, 14:50
CYTO
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Altamira Therapeutics Ltd. ("Altamira" or the "Company") (Nasdaq:CYTO), a company dedicated to developing therapeutics that address important unmet medical needs, today announced that it has received an “Intention to Grant” notice from the European Patent Office (EPO) for its patent application titled “Intranasal Composition Comprising Betahistine” (designated as European Patent 3698791).

The application is a continuation of the previously granted European Patent 3474850 and upon issuance, is expected to remain valid until February 2038. Combined, these two patents will provide key intellectual property protection for the Company's intranasal betahistine program (AM-125) in Europe. To date, the patent has been granted in around 50 countries worldwide, including key markets in North America and Europe. The allowed claims cover the composition of matter and methods of use for formulations of betahistine dihydrochloride for intranasal delivery.

“We are very pleased with the continued expansion of our patent portfolio covering the intranasal betahistine program,” commented Thomas Meyer, Altamira Therapeutics’ founder, Chairman and CEO. “Securing our intellectual property is pivotal as we strategically position our Company around our RNA delivery platform. With considerable interest from various parties, we anticipate collaborating with the appropriate partners to bring the AM-125 program to patients worldwide who are suffering from dizziness.”

About Betahistine

Betahistine, a small molecule structural analog of histamine, acts as an agonist at the H1 histamine receptor and as an antagonist at the H3 histamine receptor. Unlike histamine, it crosses the blood-brain-barrier. Betahistine is known to increase the release of histamine, acetylcholine, dopamine and norepinephrine in the brain. It increases cochlear, vestibular and cerebral blood flow and facilitates vestibular compensation and inhibits neuronal firing in the vestibular nuclei. Betahistine for oral administration is approved in about 115 countries (with the U.S. being a notable exception) for the treatment of vertigo and Meniere’s disease. Despite its good safety profile, the clinical utility of orally administered Betahistine is limited due to poor bioavailability.

About AM-125

AM-125 is an intranasal formulation of betahistine. Because of its ability to circumvent first-pass metabolism, AM-125 has been shown to have 5-to-29 times higher bioavailability than orally administered betahistine. Altamira is developing AM-125 for the treatment of acute vestibular syndrome which may be triggered by a variety of causes including trauma, infection, or inner ear fluid disturbances. With its incidence and prevalence increasing with age, vestibular dysfunction affects more than one third of the U.S. population 40 years of age and older.

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