Analysis of clinical studies with betahistine in treatment of most common cause of vertigo

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 II 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 II2 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.