- Published meta-analysis shows statistically significant improvement in dizziness handicap for betahistine treatment over standard of care procedure alone in patients suffering from BPPV
- Altamira to file IND application for intranasal betahistine (AM-125) with FDA in May 2023, including protocol for Phase 2 clinical trial in BPPV
- Altamira intends to partner or divest AM-125 as part of its legacy assets in a strategic pivot to its RNA delivery technology platforms
HAMILTON, BERMUDA / ACCESSWIRE / April 10, 2023 / Altamira Therapeutics ("Altamira" or the "Company") (Nasdaq:CYTO), a company dedicated to developing therapeutics that address important unmet medical needs, today reported highlights from a peer reviewed article showing efficacy of oral betahistine in the treatment of posterior canal benign paroxysmal positional vertigo (BPPV) when administered along with a canal repositioning procedure, the Epley maneuver.
The article was published in the journal Medicine and describes the results from a meta-analysis of nine randomized controlled trials with 860 posterior canal BPPV patients, of which 432 were treated with Epley's maneuver plus betahistine, and 428 solely underwent Epley's maneuver. The meta-analysis concluded that Epley's maneuver plus betahistine resulted in a significantly greater reduction in dizziness handicap as measured by the Dizziness Handicap Inventory (DHI) compared to Epley's maneuver alone (p = 0.001).
BPPV is characterized by repeated episodes of vertigo (dizziness) produced by changes in the head position relative to gravity, e.g. when tipping the head backward. It is typically caused by dislodged inner ear particles (otoconia) in one of the semicircular canals, most often the posterior canal. The debris elicits unwanted vestibular stimulation and is often cleared through physical repositioning procedures such as the Epley maneuver, which is strongly recommended by the Clinical Practice Guideline of the American Academy of Otolaryngology - Head and Neck Surgery. Since a patient may experience dizziness and instability for some time even after a successful maneuver, betahistine as an antivertigo drug is frequently administered to help accelerate their resolution.
BPPV is the most common type of vertigo, which accounts for 17 to 42% of all diagnosed cases. A primary complaint of dizziness accounts for 5.6 million clinic visits in the United States per year. Patients, suffering from BPPV, experience significant inconveniences and disabilities during symptomatic episodes, as they interfere with day-to-day activities such as driving a car or climbing stairs. BPPV generally emerges in the elderly with a peak onset in the fifth and sixth decades.
Altamira has been developing AM-125, a patented formulation of betahistine for intranasal administration, for the treatment of acute vestibular syndrome (AVS), which may be triggered by a variety of causes including trauma, infection or inner ear fluid disturbances such as in BPPV. By avoiding the fast metabolism after oral intake, intranasal delivery of AM-125 achieves higher bioavailability of betahistine (5-to-29 times higher). AM-125 has been successfully tested in a Phase 2 clinical trial ("TRAVERS") with patients suffering from AVS following vestibular surgery. Compared to placebo, AM-125 treatment helped accelerate vestibular compensation and alleviate signs and symptoms of vestibular dysfunction. The Company expects to file an IND application for intranasal betahistine (AM-125) with the FDA in May 2023, including the protocol for its Phase 2 clinical trial in BPPV.
"We are pleased to see betahistine's clinical utility further confirmed in this meta-analysis of several studies in BPPV patients," commented Thomas Meyer, Ph.D., Altamira's founder, chairman and CEO. "Following the positive outcomes in surgery-induced AVS in the TRAVERS trial, we feel vindicated in our choice of BPPV to advance the clinical development program for AM-125. Where marketed, BPPV has traditionally been one of the most frequent indications for oral betahistine. We look forward to submitting the IND application shortly which will be an important milestone on our way to transfer the innovative AM-125 program to one or several partners as we are repositioning the Company around our RNA delivery technology."
Globally, there has been a dearth of innovation for treating vertigo for decades. 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 shall be leveraged via out-licensing to pharma or biotech companies. In addition, Altamira is in the process of divesting and/or licensing-out 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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SOURCE: Altamira Therapeutics Ltd.
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