Altamira Therapeutics Completes Interim Sample Size Analysis of COVAMID Trial with Bentrio in Acute COVID-19

Rhea-AI Summary

Altamira Therapeutics (NASDAQ:CYTO) announces the continuation of enrollment in the COVAMID trial, increasing the participant count from 136 to 160 to enhance statistical power. The top-line results are anticipated by early Q4-22. The trial evaluates the efficacy of Bentrio, a drug-free nasal spray for COVID-19, in a randomized placebo-controlled study. Bentrio aims for label expansion into viral infections in key markets including the US and EU. The interim analysis indicated a higher standard deviation than expected, prompting the increase in subjects for rigorous efficacy testing.

Positive

• Enrollment in the COVAMID trial has increased from 136 to 160 subjects to enhance statistical power.
• Top-line data read-out from the trial is expected in early Q4-22, indicating progress in clinical evaluation.
• Bentrio has the potential for label expansion to include viral infections, increasing market reach.

Negative

• The interim analysis showed a higher standard deviation in efficacy measures than initially assumed, raising concerns about trial robustness.

HAMILTON, BERMUDA , Aug. 01, 2022 (GLOBE NEWSWIRE) --

• Enrollment to be continued to 160 subjects, adding 24 to ensure adequate statistical power
• Top-line data read-out from trial expected in early Q4-22
• COVAMID trial essential for potential label expansion into viral infection in important markets
• Company’s strategic focus is on partnering Bentrio^TM for marketing and distribution in US, EU, and other key markets

HAMILTON, BERMUDA / August 1, 2022 / Altamira Therapeutics Ltd. (NASDAQ:CYTO), a company dedicated to developing therapeutics that address important unmet medical needs, today announced that it has completed the pre-specified blinded interim sample size analysis in the COVAMID trial to evaluate its Bentrio nasal spray in patients with acute COVID-19. The Company has resumed enrollment to increase the size of the study population from the current 136 to a total of 160 subjects.

The interim analysis showed that the actual standard deviation of the primary efficacy outcome measure was somewhat higher than what had initially been assumed for the statistical powering of the study. Altamira expects to swiftly enroll the additional study participants to enhance the statistical powering for efficacy testing and plans to announce top-line data from the COVAMID trial early in the fourth quarter of 2022.

COVAMID is a randomized, placebo controlled clinical trial to evaluate the safety, tolerability, and efficacy of Bentrio. The primary efficacy endpoint will be the mean cycle threshold improvement in the customary RT-PCR test for COVID-19, i.e. the reduction of the SARS-CoV-2 load based on upper or middle throat swab samples. In the COVAMID trial, 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.

Bentrio is an OTC drug-free nasal spray for personal protection against airborne viruses and allergens. Bentrio was shown to provide effective protection from infection with SARS-CoV-2 in cultures of human nasal epithelia cells, both with prophylactic application prior to infection and mitigative application in the first 24 to 30 hours post infection.

"We look forward to a swift completion of enrollment in the COVAMID trial and to extending the size of the study population for adequate statistical powering," commented Jean Lachance, Head of Altamira’s OTC Consumer Health business unit.

"While we have already generated extensive clinical data to confirm Bentrio’s safety and efficacy in the treatment of allergic rhinitis, COVAMID will for the first time provide us with clinical data for a viral infection indication as well,” Mr. Lachance added. “The trial will be essential for supporting our plans to expand Bentrio’s product label to include viral infections in those countries and regions which are requiring supportive clinical data such as the USA, the European Union, and China.”

Altamira’s strategy is to market and distribute Bentrio through a growing network of specialized and well-established OTC consumer health companies. After already covering most of the important Asian markets through partners, except Japan, the Company’s current partnering activities are focusing on the US, EU and other key international markets. As a medical device, the marketing and  distribution of Bentrio requires prior regulatory clearance. Recently, Bentrio was cleared in the US for marketing for the treatment of allergic rhinitis.  

About Bentrio

Bentrio is a drug-free nasal spray for personal protection against airborne allergens and, where approved, against airborne viruses. 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 allergens (or virus particles) with cells; in addition, the composition serves to bind such particles and help with their discharge. Together, this is designed to promote alleviation of allergic symptoms (or mitigate upper respiratory tract viral infections). For more info, visit: https://altamiratherapeutics.com/our-products/bentrio

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 allergens and, where approved, against viruses (Bentrio™; commercial) or for the treatment of acute vestibular syndrome (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

FAQ

What is the COVAMID trial for CYTO?

The COVAMID trial is a clinical study evaluating the efficacy of Bentrio, a nasal spray, in treating acute COVID-19.

When will top-line data from the COVAMID trial be released?

Top-line data from the COVAMID trial is expected to be announced in early Q4-22.

What recent changes were made to the COVAMID trial?

The study population size was increased from 136 to 160 subjects to ensure adequate statistical power.

What is Bentrio's role in the COVAMID trial?

Bentrio is evaluated for its efficacy in reducing SARS-CoV-2 load in COVID-19 patients in the COVAMID trial.

How does the interim analysis affect CYTO's stock?

The higher than expected standard deviation in the interim analysis may impact investor confidence in the trial results.