Altamira Therapeutics (NASDAQ:CYTO) completed patient enrollment in Part B of the Phase 2 TRAVERS clinical trial evaluating intranasal betahistine (AM-125) in acute vertigo.
The company expects to release top-line results from TRAVERS towards the end of the second quarter of 2022.
“Following the positive interim results from Part A of the TRAVERS trial, completion of patient enrollment in the larger Part B of this important proof-of-concept study marks the achievement of a major milestone for our company,” Thomas Meyer, Altamira’s founder, chairman and CEO, said in a statement.
In Part B of the TRAVERS trial, 75 patients suffering from acute vertigo following neurosurgery were randomized to receive either 10 mg or 20 mg of intranasal betahistine, or placebo, three times daily for four weeks.
The primary efficacy endpoint is improvement in the Tandem Romberg test, which measures how long patients are able to maintain balance with the two feet aligned one after the other while they have their eyes closed, from baseline to day 42.
An interim analysis based on Part A of the trial, with 33 patients, demonstrated a dose-dependent improvement in balance as well as good safety and tolerability of ascending doses of AM-125.
At the highest dose of 20 mg taken three times daily, AM-125-treated patients demonstrated, on average, a 2.6-fold improvement in Tandem Romberg test performance from baseline to six weeks, compared with placebo, where balance was maintained for 9.2 seconds vs. 3.5 seconds, respectively.
This positive outcome was supported by similar improvements in additional efficacy measures, including additional objective as well as clinician- and patient-reported outcomes.
Mr. Meyer said that unlike other vertigo drugs that only treat short-term symptoms, such as nausea by suppressing the vestibular function, “AM-125 stimulates vestibular compensation, thereby helping patients to get back on their feet more quickly.”
He said there is a strong medical need for a novel drug in this area, with approximately 35% of U.S. adults aged 40 years and older suffering from vestibular dysfunction. “We look forward to advancing the AM-125 program and to bringing this innovative nasal spray to patients.”
