Altamira Therapeutics Achieves COVAMID Trial Target Enrollment for Bentrio in Acute COVID-19

Rhea-AI Summary

Altamira Therapeutics (NASDAQ:CYTO) announced reaching its target enrollment of 136 subjects in the COVAMID clinical trial, evaluating the safety and efficacy of its Bentrio nasal spray for treating acute COVID-19. The company anticipates top-line data by Q3-22, following an interim analysis to confirm statistical assumptions. Depending on the analysis, enrollment may extend to 180 patients. A positive trial outcome could lead to label expansion for Bentrio in countries requiring supportive clinical data. Bentrio is designed to protect against airborne viruses and allergens.

Positive

• Successfully reached target enrollment of 136 subjects in COVAMID trial ahead of schedule.
• Top-line data expected by Q3-22 with potential for label expansion for Bentrio if trial outcomes are favorable.

Negative

• Interim analysis could necessitate increasing enrollment to 180 patients, potentially delaying results to Q4-22.

• Reached targeted clinical trial enrollment of 136 subjects ahead of schedule
• At current patient enrollment, top-line data read-out is expected in Q3-22

HAMILTON, BERMUDA / ACCESSWIRE / June 23, 2022 / Altamira Therapeutics Ltd. (NASDAQ:CYTO), a company dedicated to developing therapeutics that address important unmet medical needs, today announced that it has reached its targeted enrollment of 136 confirmed subjects in its COVAMID clinical investigation to evaluate the safety, tolerability, and efficacy of its Bentrio™ nasal spray in patients with acute COVID-19.

Bentrio is an OTC drug-free nasal spray for personal protection against airborne viruses and allergens. It is being distributed in several countries throughout Europe and Asia and is expected to become available in progressively more countries through a growing global network of distributors.

COVAMID is a randomized, placebo controlled clinical trial to evaluate the ability of Bentrio nasal spray to reduce the SARS-CoV-2 viral load in the nose, alleviate COVID-19 signs and symptoms, and decrease the frequency of COVID-19 related hospital admissions. In the COVAMID trial, the COVID-19 patients are randomized at a 2:1:1 ratio to receive for 10 days either Bentrio, a placebo (Bentrio minus its key mineral component), or no treatment, followed by a 10-day observation phase. COVAMID is being conducted in Bulgaria and North Macedonia.

Having reached the target enrollment and following completion of data entry and verification, a pre-specified blinded interim analysis will determine whether the initial assumptions for the statistical powering of the study have been met. If confirmed, Altamira expects to announce top-line data from the COVAMID trial later in the third quarter of 2022. If, however, the interim analysis suggests that a larger sample size will be required, the Company expects to continue enrollment to up to 180 patients and, based on a similar rate of enrollment, the top-line data would then be expected to be announced in the fourth quarter.

In case of a positive outcome from the COVAMID clinical trial, the Company expects to seek an expansion of its product label to also include viral infections in countries requiring supportive clinical data. So far, Altamira has demonstrated effective protection from infection with human rhinovirus (common cold), influenza virus and SARS-CoV-2 in cell cultures with human nasal epithelia cells.

"We are delighted to have reached our target patient enrollment for COVAMID ahead of schedule," commented Thomas Meyer, Altamira Therapeutics' founder, Chairman and CEO. "After having already demonstrated Bentrio's effectiveness and utility in several clinical studies in allergic rhinitis, this is a significant milestone in our clinical development of Bentrio in viral infections. Given its unique triple mode of action and versatility against various types of viruses, we consider Bentrio well-positioned to help protect people in a world with many challenges from existing or evolving airborne viruses."

About Bentrio
Bentrio is a drug-free nasal spray for personal protection against airborne viruses and allergens. Upon application into the nose, Bentrio forms a protective gel layer on the nasal mucosa. This thin film is designed to prevent the contact of viruses or allergens with cells; in addition, the composition serves to bind such particles and help with their discharge and to humidify the nasal mucosa. Together, this is designed to reduce the risk of upper respiratory tract viral infections and promote alleviation of allergic symptoms. For more info, visit: https://altamiratherapeutics.com/our-products/bentrio

Bentrio is being distributed in selected European and Asian countries and is planned to become available through distributors in numerous other countries in Europe, Asia and MENA. In the US, Altamira submitted a 510(k) application of Bentrio in the treatment of allergic rhinitis, which is currently under review by the FDA.

About Altamira Therapeutics

Altamira Therapeutics (NASDAQ:CYTO) 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 for 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). Founded in 2003, it 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 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, 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

Investors@altamiratherapeutics.com
800-460-0183

SOURCE: Altamira Therapeutics

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FAQ

What is the COVAMID clinical trial for Altamira Therapeutics (CYTO)?

The COVAMID clinical trial evaluates the safety and efficacy of Bentrio nasal spray in patients with acute COVID-19.

When will the results from the COVAMID trial be announced?

Top-line data is expected in Q3-22, but this could be delayed to Q4-22 if a larger sample size is needed.

What is Bentrio and how does it work?

Bentrio is a drug-free nasal spray designed to protect against airborne viruses and allergens by forming a protective gel layer in the nose.

What potential outcomes could arise from the COVAMID trial for Altamira (CYTO)?

A positive outcome could lead to label expansion for Bentrio to include viral infections in additional countries.