Altamira Therapeutics Announces Publication of Positive Results from Phase 2 Trial with AM-125 in Acute Vestibular Syndrome in Leading Peer Reviewed Journal

Rhea-AI Summary

Altamira Therapeutics (Nasdaq:CYTO) announced the publication of positive results from its TRAVERS Phase 2 trial assessing AM-125 (intranasal betahistine) for surgery-induced acute vestibular syndrome (AVS). The study, published in Otology & Neurotology, involved 124 patients across Europe and demonstrated good tolerability alongside significant improvements in balance and vestibular dysfunction symptoms. Specifically, patients receiving 20 mg of AM-125 maintained balance for an average of 10.9 seconds compared to 7.4 seconds for the placebo group (p = 0.08). Altamira plans to submit an IND application to the FDA for AM-125 and aims to partner or divest this asset as it shifts focus towards RNA delivery technology.

Positive

• Successful publication of TRAVERS trial results indicates proof of concept for AM-125.
• Demonstrated good tolerability of AM-125 in patients.
• Significant improvement in balance and vestibular dysfunction symptoms observed.
• Plans to submit IND application for AM-125 to FDA.

Negative

• Regulatory approval timeline and commercialization outcomes for AM-125 remain uncertain.
• Potential challenges in partnering or divesting AM-125 amid strategic pivot.

• Detailed results from TRAVERS trial addressing acute vestibular syndrome with AM-125 (intranasal betahistine) published in Otology & Neurotology
• Study demonstrates proof of concept and shows good tolerability
• TRAVERS shows time and dose dependent acceleration of vestibular compensation and alleviation of signs and symptoms of vestibular dysfunction
• Altamira intends to partner or divest AM-125, part of its legacy assets, in a strategic pivot to RNA delivery technology

HAMILTON, BERMUDA / ACCESSWIRE / April 12, 2023 / Altamira Therapeutics ("Altamira" or the "Company") (Nasdaq:CYTO), a company dedicated to developing therapeutics that address important unmet medical needs, today announced the publication of the detailed results from its TRAVERS Phase 2 trial with AM-125 (intranasal betahistine) in surgery-induced acute vestibular syndrome (AVS). The peer-reviewed article was published in Otology & Neurotology, one of the leading journals in scientific and clinical inner ear research.[1]

The randomized, double-blind, placebo-controlled TRAVERS trial enrolled a total of 124 patients, at more than ten study sites across Europe, who suffered from AVS following surgery for the removal of a tumor. AVS is characterized by the sudden onset of continuous vertigo lasting days to weeks and may be associated with nausea, head motion intolerance, and unstable balance. Study participants 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 manage to maintain balance with their two feet aligned one in front of the other while they have their eyes closed, served as the primary efficacy outcome.

The TRAVERS trial demonstrated good tolerability of AM-125. Further, administration of AM-125 resulted in a dose- and time-dependent improvement in balance, and signs and symptoms of vestibular dysfunction. At treatment period end, on average, patients treated with 20 mg AM-125 managed to maintain balance for 10.9 seconds vs. 7.4 seconds for placebo treated patients in the "intention to treat" analysis and 12.5 seconds vs. 7.5 seconds in the "per protocol" analysis (p = 0.08 and 0.02, respectively)[2]. This was corroborated by a higher frequency of complete resolution of spontaneous eye movements (nystagmus), a hallmark and objective indicator of vestibular imbalance and vertigo (34.5% vs. 20.0% after the treatment period and 45.2% vs. 25.8% after six weeks). Subjective vestibular deficit, as measured by the Vestibular Rehabilitation Benefit Questionnaire, decreased more under AM-125 20 mg than placebo treatment at all study visits.

"The demonstration of proof of concept in the TRAVERS trial marks a major milestone in the development of AM-125 as innovative treatment for acute vestibular syndrome," commented Thomas Meyer, Altamira Therapeutics' founder, Chairman and CEO. "The trial's main outcomes suggest that AM-125 helps to accelerate vestibular compensation and patients to regain balance and recover faster. By administering betahistine with a nasal spray, we are addressing a major shortcoming of betahistine, which is poor oral bioavailability resulting in very low concentrations of the active substance in the blood circulation. In our next steps, we look forward to submitting an IND application for AM-125 to the FDA next month, and to moving the innovative AM-125 program forward with one or several partners as we are repositioning the Company around our RNA delivery technology."

About Betahistine

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.

About AM-125

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 is planned to be leveraged via out-licensing to pharma or biotech companies. In addition, Altamira is in the process of divesting and/or out-licensing 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/

Forward-Looking Statements

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 success of the continued commercialization of Bentrio and success of strategic transactions, including licensing or partnering, with respect to Bentrio or any other legacy assets, 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, 2021, 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.

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[1] Van de Heyning et al. (2023), Efficacy and safety of intranasal betahistine in the treatment of surgery-induced acute vestibular syndrome: A double-blind, randomized, placebo-controlled phase 2 study, Otol Neurotol, online ahead of print https://doi.org/10.1097/mao.0000000000003856

[2] Least square means in repeated-measure ANCOVA model.

SOURCE: Altamira Therapeutics

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FAQ

What are the results of the TRAVERS trial for AM-125?

The TRAVERS trial showed significant improvements in balance and vestibular function, with AM-125 demonstrating good tolerability.

What does the TRAVERS trial indicate for AM-125's future?

It indicates proof of concept and supports further development, leading to plans for an IND submission to the FDA.

What is Altamira Therapeutics' strategy regarding AM-125?

Altamira intends to partner or divest AM-125 as part of a strategic pivot towards RNA delivery technologies.

How does AM-125 compare in efficacy to the placebo?

AM-125 treated patients showed an average balance maintenance of 10.9 seconds versus 7.4 seconds for placebo.

What is Acute Vestibular Syndrome (AVS)?

AVS is characterized by sudden vertigo and instability, often following surgical procedures.