Altamira Therapeutics Completes Enrollment for COVAMID Trial with Bentrio in Acute COVID-19
Altamira Therapeutics (NASDAQ:CYTO) announced it has reached its extended enrollment target of 160 patients in the COVAMID clinical trial, which evaluates the efficacy of Bentrio™ nasal spray for acute COVID-19 treatment. Top-line data is anticipated in Q4-2022. Bentrio, a drug-free nasal spray, is designed to protect against airborne viruses and allergens and has recently received OTC marketing clearance in the US for allergic rhinitis. A successful trial outcome could expand its product label to include viral infections.
- Enrollment target of 160 patients reached in COVAMID trial.
- Top-line data expected in Q4-2022.
- Bentrio cleared for OTC marketing in the US; increasing global availability.
- Potential label expansion to include viral infections upon positive trial results.
- No current revenue reported from Bentrio despite increasing marketing efforts.
HAMILTON, BERMUDA , Sept. 13, 2022 (GLOBE NEWSWIRE) --
- Study has reached extended enrollment target of 160 patients
- Top-line data read-out expected in Q4-22
Altamira Therapeutics Ltd. (NASDAQ:CYTO), a company dedicated to developing therapeutics that address important unmet medical needs, today announced that it has reached its extended enrollment target of 160 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 designed for protection against airborne viruses and allergens. It is being marketed in several countries throughout Europe and Asia to help protect against allergic rhinitis and, where approved, against viral infection. Recently, Bentrio was cleared in the US for OTC marketing for the treatment of allergic rhinitis. It 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.
Following a blinded interim analysis, the Company in early August announced that the size of the COVAMID study population would be increased from 136 to 160 patients to ensure adequate statistical power. Altamira expects to announce top-line data from the COVAMID trial during the fourth quarter of 2022.
With a positive outcome from the COVAMID clinical trial, the Company plans to seek an expansion of its product label to also include viral infections in those countries requiring supportive clinical data. So far, Altamira has demonstrated that Bentrio provides 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 glad to have swiftly completed the additional patient enrollment for COVAMID,” commented Jean Lachance, Head of Altamira’s OTC Consumer Health business unit. “Based on the compelling results which we already achieved with Bentrio in several SARS-CoV-2 assays, we are confident to see the protective effects confirmed also in a clinical setting. We consider Bentrio well-positioned to help protect people in a world with manifold and growing exposures to airborne viruses -- for which Covid-19 has dramatically raised consumer awareness.”
About Bentrio
Bentrio is an OTC 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 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.
FAQ
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