- 75 patients randomized in Part B of study to receive either intranasal betahistine or placebo
- Top-line results from the trial expected to be announced in Q2-2022
HAMILTON, BERMUDA / ACCESSWIRE / February 14, 2022 / Altamira Therapeutics Ltd. (NASDAQ:CYTO), a company dedicated to developing therapeutics that address important unmet medical needs, today announced completion of 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," commented Thomas Meyer, Altamira Therapeutics' founder, Chairman and CEO. "For patients suffering from acute vertigo, regaining balance as quickly as possible is of utmost importance. 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. 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.1 We look forward to advancing the AM-125 program and to bringing this innovative nasal spray to patients."
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 (i.e. two weeks after completion of treatment).
An interim analysis based on Part A of the trial (n=33) demonstrated a dose-dependent improvement in balance as well as good safety and tolerability of ascending doses of AM-125 (1 mg, 10 mg and 20 mg). At the highest dose of 20 mg (taken 3 x daily), AM-125-treated patients demonstrated, on average, a 2.6-fold improvement in Tandem Romberg test performance from baseline to six weeks, compared to those who received placebo (balance was maintained for 9.2 seconds vs. 3.5 seconds, respectively [least square mean], p-value < 0.001). This positive outcome was supported by similar improvements in additional efficacy measures, including additional objective as well as clinician- and patient-reported outcomes.
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 vertigo. 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.
1 Agrawal Y et al. (2009), Disorders of Balance and Vestibular Function in US Adults - Data From the National Health and Nutrition Examination Survey, 2001-2004, Arch Intern Med. 169(10):938-944.
About Altamira Therapeutics
Altamira Therapeutics is dedicated to developing therapeutics that address important unmet medical needs. The Company is currently active in three areas: the development of RNA therapeutics for extrahepatic therapeutic targets (OligoPhore™ / SemaPhore™ platforms; preclinical), nasal sprays for protection against airborne viruses and allergens (Bentrio™; commercial) or the treatment of vertigo (AM-125; Phase 2), and the development of therapeutics for intratympanic treatment of tinnitus or hearing loss (Keyzilen® and Sonsuvi®, Phase 3). The Company was founded in 2003 and is headquartered in Hamilton, Bermuda with its main operations in Basel, Switzerland. The shares of Altamira Therapeutics Ltd. trade on the NASDAQ Capital Market under the symbol "CYTO."
This press release may contain statements that constitute "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements are statements other than historical facts and may include statements that address future operating, financial or business performance or Altamira Therapeutics' strategies or expectations. In some cases, you can identify these statements by forward-looking words such as "may", "might", "will", "should", "expects", "plans", "anticipates", "believes", "estimates", "predicts", "projects", "potential", "outlook" or "continue", or the negative of these terms or other comparable terminology. Forward-looking statements are based on management's current expectations and beliefs and involve significant risks and uncertainties that could cause actual results, developments and business decisions to differ materially from those contemplated by these statements. These risks and uncertainties include, but are not limited to, the approval and timing of commercialization of AM-301, Altamira Therapeutics' need for and ability to raise substantial additional funding to continue the development of its product candidates, the timing and conduct of clinical trials of Altamira Therapeutics' product candidates, the clinical utility of Altamira Therapeutics' product candidates, the timing or likelihood of regulatory filings and approvals, Altamira Therapeutics' intellectual property position and Altamira Therapeutics' financial position, including the impact of any future acquisitions, dispositions, partnerships, license transactions or changes to Altamira Therapeutics' capital structure, including future securities offerings. These risks and uncertainties also include, but are not limited to, those described under the caption "Risk Factors" in Altamira Therapeutics' Annual Report on Form 20-F for the year ended December 31, 2020, and in Altamira Therapeutics' other filings with the SEC, which are available free of charge on the Securities Exchange Commission's website at: www.sec.gov. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those indicated. All forward-looking statements and all subsequent written and oral forward-looking statements attributable to Altamira Therapeutics or to persons acting on behalf of Altamira Therapeutics are expressly qualified in their entirety by reference to these risks and uncertainties. You should not place undue reliance on forward-looking statements. Forward-looking statements speak only as of the date they are made, and Altamira Therapeutics does not undertake any obligation to update them in light of new information, future developments or otherwise, except as may be required under applicable law.
SOURCE: Altamira Therapeutics Ltd.
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