- 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.'
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/
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SOURCE: Altamira Therapeutics
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