- Swift progress of study enrollment - midpoint of 50 patients reached
- Interim analysis confirmed target enrollment of 100 patients
- Completion of enrollment expected by early January 2023
HAMILTON, BERMUDA / ACCESSWIRE / December 2, 2022 / Altamira Therapeutics Ltd. (NASDAQ:CYTO), a company dedicated to developing therapeutics that address important unmet medical needs, today announced that it has reached the midpoint for enrollment in its "NASAR" clinical trial with Bentrio in Season Allergic Rhinitis (SAR). Based on the accumulated data from the first 53 participants, an interim analysis confirmed the enrollment target of 100 patients for appropriate statistical powering of the study.
The randomized controlled NASAR trial is designed to compare the safety and efficacy of Bentrio against a saline nasal spray. Study participants are randomized at a 1:1 ratio to either receive Bentrio or saline spray via self-administration three times per day, or as needed, for two weeks. The primary endpoint will be the comparison of the reflective Total Nasal Symptom Score (rTNSS) under treatment with Bentrio against saline spray. The NASAR trial was initiated in fall of 2021 and resumed enrollment in September 2022 with the start of the new pollen season in Australia. Based on current enrollment rates, Altamira expects to complete enrollment by early January 2023 and obtain top-line data in late Q1 2023.
"With the annual pollen season in Australia in full swing, we are pleased to see enrollment into the NASAR study progressing swiftly," commented Thomas Meyer, Altamira Therapeutics' founder, Chairman and CEO. "The NASAR study will allow for a head-to-head comparison of Bentrio with saline nasal sprays, which are currently the most popular drug-free treatment for allergic rhinitis. We are very confident to show superior efficacy of Bentrio thanks to its triple mode of action and long nasal residence time."
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, viruses (Bentrio™; commercial) or for the treatment of vertigo (AM-125; post 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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