Altamira Therapeutics Ltd. (NASDAQ:CYTO) shares subside slightly Monday, after it announced positive top-line data from its exploratory Phase 2 TRAVERS trial with AM-125 (intranasal betahistine) in acute vertigo and provided an update on its development plans.
The randomized, double-blind, placebo-controlled TRAVERS trial enrolled at more than ten study sites across Europe a total of 124 patients who suffered from acute vertigo following neurosurgery for the removal of a tumor. Patients 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 are able to maintain balance with their two feet aligned one after the other while they have their eyes closed, served as the primary efficacy outcome. For reference, the trial also included 16 patients who received ‘open label' oral betahistine at 16 mg three times daily (the approved dose in most countries worldwide).
The TRAVERS trial demonstrated good safety and tolerability of AM-125 at doses up to 20 mg administered three times daily for four weeks. Further, administration of AM-125 resulted in a dose- and time-dependent improvement in balance and vestibular function.
At the end of the treatment period, patients treated with AM-125 20 mg on average managed to maintain balance for 12.5 seconds vs. 7.5 seconds for placebo treated patients, which is a statistically significant improvement (p=0.0242; least square means in repeated-measure ANCOVA model, per protocol population).
CYTO shares dipped half a cent to 56 cents.
