Company's drug-free nasal spray demonstrated a statistically significant reduction of nasal symptoms vs. untreated controls as well as good tolerability and safety
HAMILTON, BERMUDA / ACCESSWIRE / May 20, 2022 / Altamira Therapeutics Ltd. (NASDAQ:CYTO), a company dedicated to developing therapeutics that address important unmet medical needs, today announced positive top-line data from its clinical trial with Bentrio™ nasal spray in house dust mite ("HDM") allergic rhinitis.
The HDM challenge trial demonstrated a statistically significant reduction of nasal symptoms vs. untreated controls as well as good tolerability and safety. Bentrio is a drug-free nasal spray intended for personal protection against airborne viruses and allergens with a triple mode of action.
At a single Canadian study site, the trial enrolled a total of 37 patients with a history of perennial allergic rhinitis ("PAR") caused by HDM exposure. Study participants were randomized under an open label, three-period crossover design to receive either Bentrio in a single or double dose, or no treatment, prior to controlled allergen exposure in an environmental exposure chamber for three hours.
The primary endpoint was the change in the Total Nasal Symptom Score (TNSS; determined in 20-minute intervals) from baseline. The ANCOVA (analysis of covariance) model showed that Bentrio treatment reduced the increase in mean TNSS during the 3-hour exposure by 1.1 points (-1.87 to -0.28 in the 95% confidence interval; p<0.01) vs. no treatment. Under Bentrio treatment, the mean TNSS was 4.1 points vs. 5.2 points under no treatment.
The changes in TNSS started to separate at the 40-minute time point and, on average, reached 1.5 to 2 points from the mid-point to the end of exposure. The protective effect was observed both with a single or double puff per nostril with no meaningful difference between the two treatment approaches. Regarding safety, there were only few adverse events, mostly mild, and more than 85% of study participants rated the tolerability of Bentrio as "good" or "very good."
"We are delighted with the outcome from the house dust mite challenge study as it confirms Bentrio's ability to effectively and safely protect against various types of airborne allergens," commented Thomas Meyer, Altamira Therapeutics' founder, Chairman and CEO. "The positive data from this perennial allergic rhinitis study is congruent with the favorable outcomes from our previous study of grass pollen in seasonal allergic rhinitis.
"Interestingly, we found that one puff per nostril is sufficient to achieve the desired protection," Mr. Meyer added. "We look forward to continuing the commercial roll-out of Bentrio, helping to provide relief for those many allergy sufferers who have been looking for an effective over-the-counter treatment without any drug or preservative ingredients."
About House Dust Mite Allergies
HDM allergens constitute the prime cause of respiratory allergies (i.e. allergic rhinitis and allergic asthma), with prevalence estimates for allergen sensitization ranging between 65 and 130 million persons in the general population worldwide, or as much as 50% among asthmatic patients.1 In the US population aged 6 years and older, dust mite allergens are the second most common source of sensitization right after plant-related allergens (20.3 and 27.1%, respectively).2 Unlike plant-related allergens, which tend to be seasonal (e.g. pollen / hay fever), HDMs may be present all year long. Symptoms of HDM allergies include sneezing, a runny or stuffy nose, itching, coughing, difficulty breathing, and chest tightness or pain.
1 Calderon et al. (2015), Respiratory allergy caused by house dust mites: What do we really know?, J Allergy Clin Immunol 136(1):38-48.
2 Salo et al. (2014), Prevalence of allergic sensitization in the United States: results from the National Health and Nutrition Examination Survey (NHANES) 2005-2006. J Allergy Clin Immunol 134(2):350-9.
Bentrio (AM-301) is a drug-free nasal spray intended 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.
About Altamira Therapeutics
Altamira Therapeutics 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). The Company was founded in 2003 and is headquartered in Hamilton, Bermuda with its main operations in Basel, Switzerland. The shares of Altamira Therapeutics Ltd. trade on the NASDAQ Capital Market under the symbol "CYTO."
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 and 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.
SOURCE: Altamira Therapeutics