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 BentrioTM 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.
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/
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