- Detailed results from TRAVERS trial addressing acute vestibular syndrome with AM-125 (intranasal betahistine) published in Otology & Neurotology
- Study demonstrates proof of concept and shows good tolerability
- TRAVERS shows time and dose dependent acceleration of vestibular compensation and alleviation of signs and symptoms of vestibular dysfunction
- Altamira intends to partner or divest AM-125, part of its legacy assets, in a strategic pivot to RNA delivery technology
HAMILTON, BERMUDA / ACCESSWIRE / April 12, 2023 / Altamira Therapeutics ("Altamira" or the "Company") (Nasdaq:CYTO), a company dedicated to developing therapeutics that address important unmet medical needs, today announced the publication of the detailed results from its TRAVERS Phase 2 trial with AM-125 (intranasal betahistine) in surgery-induced acute vestibular syndrome (AVS). The peer-reviewed article was published in Otology & Neurotology, one of the leading journals in scientific and clinical inner ear research.
The randomized, double-blind, placebo-controlled TRAVERS trial enrolled a total of 124 patients, at more than ten study sites across Europe, who suffered from AVS following surgery for the removal of a tumor. AVS is characterized by the sudden onset of continuous vertigo lasting days to weeks and may be associated with nausea, head motion intolerance, and unstable balance. Study participants were randomized to receive either AM-125 at up to 20 mg, or a placebo, three times daily for four weeks, which was followed by a two-week treatment-free observation period. In addition, all trial participants followed a standardized course of vestibular rehabilitation therapy. Improvement in the "Tandem Romberg" test, which measures how long patients manage to maintain balance with their two feet aligned one in front of the other while they have their eyes closed, served as the primary efficacy outcome.
The TRAVERS trial demonstrated good tolerability of AM-125. Further, administration of AM-125 resulted in a dose- and time-dependent improvement in balance, and signs and symptoms of vestibular dysfunction. At treatment period end, on average, patients treated with 20 mg AM-125 managed to maintain balance for 10.9 seconds vs. 7.4 seconds for placebo treated patients in the "intention to treat" analysis and 12.5 seconds vs. 7.5 seconds in the "per protocol" analysis (p = 0.08 and 0.02, respectively). This was corroborated by a higher frequency of complete resolution of spontaneous eye movements (nystagmus), a hallmark and objective indicator of vestibular imbalance and vertigo (34.5% vs. 20.0% after the treatment period and 45.2% vs. 25.8% after six weeks). Subjective vestibular deficit, as measured by the Vestibular Rehabilitation Benefit Questionnaire, decreased more under AM-125 20 mg than placebo treatment at all study visits.
"The demonstration of proof of concept in the TRAVERS trial marks a major milestone in the development of AM-125 as innovative treatment for acute vestibular syndrome," commented Thomas Meyer, Altamira Therapeutics' founder, Chairman and CEO. "The trial's main outcomes suggest that AM-125 helps to accelerate vestibular compensation and patients to regain balance and recover faster. By administering betahistine with a nasal spray, we are addressing a major shortcoming of betahistine, which is poor oral bioavailability resulting in very low concentrations of the active substance in the blood circulation. In our next steps, we look forward to submitting an IND application for AM-125 to the FDA next month, and to moving the innovative AM-125 program forward with one or several partners as we are repositioning the Company around our RNA delivery technology."
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.
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 Therapeutics is developing AM-125 for the treatment of acute vestibular syndrome. 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.
About Altamira Therapeutics
Altamira Therapeutics (Nasdaq:CYTO) is dedicated to developing RNA-based therapeutics for extrahepatic targets (OligoPhore™ / SemaPhore™ delivery platforms). The Company currently has two flagship siRNA programs in preclinical development beyond in vivo proof of concept: AM-401 for KRAS driven cancer and AM-411 for rheumatoid arthritis. The versatile delivery platform is also suited for mRNA and other types of RNA therapeutics and is planned to be leveraged via out-licensing to pharma or biotech companies. In addition, Altamira is in the process of divesting and/or out-licensing its legacy assets in allergology and viral infection (Bentrio® OTC nasal spray; commercial) and inner ear therapeutics (AM-125 nasal spray for vertigo; post Phase 2; Keyzilen® and Sonsuvi® for tinnitus and hearing loss; Phase 3). Founded in 2003, Altamira is headquartered in Hamilton, Bermuda, with its main operations in Basel, Switzerland. For more information, visit: https://altamiratherapeutics.com/
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 Van de Heyning et al. (2023), Efficacy and safety of intranasal betahistine in the treatment of surgery-induced acute vestibular syndrome: A double-blind, randomized, placebo-controlled phase 2 study, Otol Neurotol, online ahead of print https://doi.org/10.1097/mao.0000000000003856
 Least square means in repeated-measure ANCOVA model.
SOURCE: Altamira Therapeutics