Altamira Therapeutics Reports Positive Conclusions from Independent Meta-Analysis of Clinical Studies with Betahistine in Treatment of Most Common Cause of Vertigo

Rhea-AI Summary

Altamira Therapeutics (Nasdaq:CYTO) announced positive results from a meta-analysis highlighting the effectiveness of betahistine in treating posterior canal benign paroxysmal positional vertigo (BPPV). The study included 860 patients and showed a statistically significant reduction in dizziness handicap when betahistine was added to the Epley maneuver (p = 0.001). The company plans to file an IND application for AM-125, an intranasal formulation of betahistine, with the FDA in May 2023, alongside the protocol for a Phase 2 clinical trial targeting BPPV. This development aligns with Altamira's strategic pivot towards its RNA delivery technology platforms, with intentions to partner or divest AM-125 as a legacy asset.

Positive

• Meta-analysis indicates significant efficacy of betahistine combined with Epley maneuver in reducing dizziness handicap.
• Plans to file IND application for AM-125 with FDA, marking a milestone in clinical development.
• AM-125 demonstrates 5-to-29 times higher bioavailability than oral betahistine, enhancing treatment potential.

Negative

• BPPV treatment market potential remains limited in the U.S. due to lack of FDA approval for oral betahistine.
• -

• Published meta-analysis shows statistically significant improvement in dizziness handicap for betahistine treatment over standard of care procedure alone in patients suffering from BPPV
• Altamira to file IND application for intranasal betahistine (AM-125) with FDA in May 2023, including protocol for Phase 2 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

HAMILTON, BERMUDA / ACCESSWIRE / April 10, 2023 / Altamira Therapeutics ("Altamira" or the "Company") (Nasdaq:CYTO), a company dedicated to developing therapeutics that address important unmet medical needs, today reported highlights from a peer reviewed article showing efficacy of oral betahistine in the treatment of posterior canal benign paroxysmal positional vertigo (BPPV) when administered along with a canal repositioning procedure, the Epley maneuver.

The article was published in the journal Medicine^[1] 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.^[2] 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 2 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 2 clinical trial in BPPV.

"We are pleased to see betahistine's clinical utility further confirmed in this meta-analysis of several studies in BPPV patients," commented Thomas Meyer, Ph.D., Altamira's founder, chairman and CEO. "Following the positive outcomes in surgery-induced AVS in the TRAVERS trial, we feel vindicated in our choice of BPPV to advance the clinical development program for AM-125. Where marketed, BPPV has traditionally been one of the most frequent indications for oral betahistine. We look forward to submitting the IND application shortly which will be an important milestone on our way to transfer the innovative AM-125 program to one or several partners as we are repositioning the Company around our RNA delivery technology."

About Betahistine

Globally, there has been a dearth of innovation for treating vertigo for decades. 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 shall be leveraged via out-licensing to pharma or biotech companies. In addition, Altamira is in the process of divesting and/or licensing-out 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.

Contact:

Hear@altamiratherapeutics.com
800-460-0183

SOURCE: Altamira Therapeutics Ltd.

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https://www.accesswire.com/748222/Altamira-Therapeutics-Reports-Positive-Conclusions-from-Independent-Meta-Analysis-of-Clinical-Studies-with-Betahistine-in-Treatment-of-Most-Common-Cause-of-Vertigo

FAQ

What were the results of the meta-analysis regarding betahistine treatment for BPPV?

The meta-analysis showed that betahistine combined with the Epley maneuver significantly reduced dizziness handicap compared to the maneuver alone (p = 0.001).

When does Altamira plan to file the IND application for AM-125?

Altamira is set to file the IND application for AM-125 with the FDA in May 2023.

What is AM-125 and its significance in treating vestibular disorders?

AM-125 is an intranasal formulation of betahistine, offering higher bioavailability and potential for effectively treating acute vestibular syndrome including BPPV.

What is the strategic direction for Altamira Therapeutics following this PR?

Altamira intends to partner or divest AM-125 while pivoting its focus towards RNA delivery technology platforms.

What is the prevalence of BPPV in the U.S.?

BPPV accounts for 17 to 42% of all diagnosed vertigo cases and leads to approximately 5.6 million clinic visits annually in the U.S.