Altamira Therapeutics Highlights New Review Supporting Betahistine for Vertigo

25 June 2024

A recent independent review has provided evidence supporting the use of betahistine to alleviate residual dizziness in patients with benign paroxysmal positional vertigo (BPPV) after undergoing physical repositioning procedures. Betahistine, which is widely marketed globally except in the United States, is considered a standard treatment for dizziness and vertigo. Altamira Therapeutics Ltd., a company specializing in RNA delivery technology, is developing AM-125, a nasal spray formulation of betahistine, to address the low bioavailability issues seen with the oral form and make it available to U.S. patients.

An article published in the journal "Frontiers in Neurology" by a group of international experts in vestibular disorders reviewed the use of betahistine for treating residual dizziness post-repositioning procedures for BPPV. Residual dizziness occurs in approximately 31-61% of patients after such procedures. The article explores potential causes of this dizziness, including remaining inner ear particles, incomplete vestibular compensation, or microcirculation dysfunction, and discusses treatment options.

BPPV, characterized by episodes of vertigo due to changes in head position relative to gravity, is the most common type of vertigo, accounting for 17-42% of all diagnosed cases. In the U.S., healthcare costs for BPPV diagnosis alone are nearly $2 billion annually. Patients with BPPV face significant inconveniences and disabilities, as the vertigo episodes can affect daily activities such as driving or climbing stairs. About 86% of BPPV patients experience interruptions in daily activities and lost workdays due to the condition, which typically affects the elderly, with peak onset in the 5th and 6th decades of life.

Despite successful physical repositioning procedures like the Epley maneuver, which is recommended by the American Academy of Otolaryngology–Head and Neck Surgery, patients may still experience residual dizziness for days to weeks, affecting their quality of life. The article suggests utilizing vestibular habituation therapies and rehabilitation programs to aid vestibular compensation and betahistine to improve inner ear blood supply and promote compensation. A previous meta-analysis had shown that combining physical repositioning with betahistine treatment significantly reduced dizziness handicap compared to repositioning alone.

Dr. Thomas Meyer, founder, chairman, and CEO of Altamira, welcomed the research, noting that addressing residual dizziness after BPPV treatment is a critical application for betahistine. He highlighted the development of AM-125, an intranasal formulation with higher bioavailability than the oral form, aimed at making betahistine available to U.S. patients. As part of Altamira's strategic shift to RNA delivery technology, the company plans to partner or divest the AM-125 program to advance its availability.

Betahistine, a small molecule analog of histamine, acts as an H1 receptor agonist and H3 receptor antagonist and crosses the blood-brain barrier, increasing the release of various neurotransmitters and blood flow in the inner ear and brain. Despite its good safety profile, oral betahistine has limited clinical utility due to poor bioavailability. 

AM-125, the intranasal formulation, bypasses first-pass metabolism, resulting in significantly higher bioavailability. Altamira is developing AM-125 to treat acute vestibular syndrome (AVS) and has successfully tested it in a Phase 2 clinical trial, showing that it can accelerate vestibular compensation and alleviate vestibular dysfunction symptoms.

Altamira Therapeutics, headquartered in Hamilton, Bermuda, with main operations in Basel, Switzerland, develops peptide-based nanoparticle technologies for RNA delivery to extrahepatic tissues. The company has two flagship siRNA programs targeting KRAS-driven cancer and rheumatoid arthritis and holds a significant stake in Altamira Medica AG, which markets Bentrio®, a nasal spray for allergic rhinitis. Altamira is currently partnering or divesting its inner ear legacy assets as part of its strategic pivot.

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