Bermuda-registered Altamira ready for Omicron test
Bermuda-registered Altamira Therapeutics Ltd has been setting up contracts with wholesalers in its lead market, Germany, covering more than 50 per cent of German pharmacies, as it begins its European rollout of Bentrio™, its nasal spray for protection against airborne viruses and allergens.
The product is becoming available through Amazon in key German markets, while a marketing and distribution agreement has already been signed for six Asian countries.
There are now preparations for a Covid-19 trial, including tests against the Omicron variant.
Following successful testing of Bentrio™ against the Delta variant of SARS-CoV-2 in a human nasal epithelia model, the company is now planning to also evaluate the product's effectiveness against the Omicron variant.
Preparations for the conduct of a clinical trial to further confirm the efficacy and safety of Bentrio™ are progressing.
Following formal classification of Bentrio™ as a medical device, the trial application is now going through the regular approval process with the Drugs Controller General of India.
Meanwhile, the company has decided to broaden the geographic scope of the study and include two countries in South-East Europe for which trial applications will be submitted shortly under "fast-track" conditions.
Given the broad applicability of Bentrio™, the company expects to observe protective effects in this assay also against the new and fast-spreading variant.
Altamira Therapeutics is dedicated to addressing unmet medical needs through RNA therapeutics, allergy and viral infection protection, and inner-ear therapeutics.
Sales through "brick and mortar" pharmacies, which still represent the vast majority of the OTC market in Germany, have been increasing steadily and are expected to be boosted further through various marketing initiatives planned for the first quarter of 2022.
The Amazon platform will soon be expanded to other European markets. In Switzerland, Bentrio™ will become available in early January under a distribution agreement.
The company has applied through the US Food and Drug Administration for premarket clearance, so that it can be used for protection against airborne allergens in mid-October.
As part of the review process, the company has been aiming to make Bentrio™ available to people suffering from allergic rhinitis also in the US.
In addition, the company and Wellesta Holdings Pte Ltd, Singapore, entered into a definite marketing and distribution agreement for six Asian countries — India, Indonesia, Malaysia, Singapore, Taiwan and Vietnam.
A letter of understanding had been signed between the two companies in October, under which Wellesta has since obtained the first of the national registrations for Bentrio™ in their sales territory. Based on various ongoing discussions, the company expects to expand the geographic footprint for Bentrio™ further through agreements with additional international distributors.
"We are pleased to report further progress with the international rollout of Bentrio, as well as with the further preclinical and clinical evaluation of Bentrio's protective effects against airborne viruses and allergens," commented Thomas Meyer, Altamira Therapeutics' founder, Chairman and CEO. "The rapid and global spread of the Omicron variant of SARS-CoV-2 is highlighting once more the need for simple, yet versatile protective measures to complement classic approaches such as vaccination, protective mask wearing or social distancing."
In recent weeks, two clinical trials with Bentrio™ started enrolling patients suffering from allergies due to airborne allergens. In the "NASAR" trial, the company plans to enrol 100 patients suffering from seasonal allergic rhinitis for a two-week treatment course, and in the second trial, 36 patients suffering from perennial allergic rhinitis due to house dust mite exposure. Results from the studies are expected in the first half of 2022.