A new nasal spray which forms a thin layer of gel that helps trap and kill COVID-19 has launched in the UK.
A real-world user survey involving a super-spreader event also found that the spray reduced the risk of COVID-19 infection by 78%.
But according to Dr Dalia Meggido, co-founder and chief executive officer of Nasus Pharma, the Israeli biopharma company which developed the spray, it’s still not a substitute for masks.
“Masks clearly help prevent infections, but they do not offer 100% protection. Taffix provides an additional layer of protection, which is particularly useful in high-risk settings such as public transport, shops and schools — basically any enclosed space.”
It was just four months between the idea for Taffix being borne in March 2020 and the first independent laboratory trials of the product, which were conducted at the University of Virginia in July.
These trials – headed up by Professor Barbara Mann from the university’s department of infectious diseases and international health – showed that Taffix killed 99.99% of live SARS-CoV-2 — the virus which causes COVID-19.
And because Taffix is built on an existing, proven, and safe medical technology – which is already used in nasal sprays to combat allergies and the common cold — both the Israeli Ministry of Health and European regulators fast-tracked approvals.
But Nasus Pharma had a head start. As its name suggests, the company had already spent three years developing nasal spray products for rapid delivery of life-saving drugs.
When it began work on Taffix, the company already had a nasal spray that delivers the opioid rescue naxolone more rapidly, and easily, than injections, which was in the final stage of the clinical trial. Another specially formulated spray to treat anaphylactic shock was also in clinical trials.
The concept sounds simple, but as Dr Meggido says: “It requires very complicated and sophisticated technology to create a gel with particles that are small enough to cover the nasal membrane, but not small enough to get into the lungs — and we had that technology.”
Dr Meggido believes: “Taffix is a powerful, clinically proven tool which will help us restart economic and social activity — and allow a return to some sort of normality.”
THE TAFFIX TECHNOLOGY
But there are several unique — and crucial — differences between Taffix and earlier HPMC sprays.
The particles in Taffix are much smaller than those found in existing products. In existing products, the particles range from between 0.2 microns and 400 microns, with an average particle size of 72.6 microns. By comparison, particles in Taffix range from only 10 microns to 100 microns in size, and their average size is 19.1 microns.
There is also a lot of variation in the shape of particles found in commercial HPMC products, which creates gaps and weak points in the gel coating. By comparison, the particles in Taffix are uniformly spherical, which makes them more effective at stopping viruses and other small particles from reaching nasal membranes.
Unlike existing products, Taffix provides dual-action protection. On top of its highly effective physical barrier, Taffix kills viruses by gently altering the pH within the nasal cavity.
GP Dr Gill Jenkins said: “The pH of the nasal cavity is usually around 6.8, which is almost neutral on the scale of acidity to alkalinity. This unfortunately is an ideal environment for viral growth.
“Studies show that no respiratory viruses, including coronaviruses, can survive in a pH of 3.5 (which is slightly acidic) or below without harming the nasal mucosal cells.”
Taffix contains tiny amounts of citric acid, which shifts the pH balance down to 3.5pH.
The patented technology used in Taffix also ensures that the citric acid is distributed evenly so the pH is reduced uniformly. This unique combination of a uniformly even coating, with a uniformly even distribution of mild acidity, turns the protective barrier gel into a viral killing zone.
In-vitro studies have confirmed Taffix helps block and kill viruses, and protects against infection.
In one study, at the University of Virginia, aimed to test whether the Taffix can form a protective barrier against SARS-CoV-2, a gel of Taffix was performed on a 40 mm nylon filter, and then seeded with 10,000 PFUs of the virus. An untreated filter, seeded with the same amount of virus, was used as an untreated control.
After a 10-minute incubation the bottom of the filters was washed with culture media and then tested for live virus by plaque assay and for viral RNA using qRT (the test used to identify infected people and measures the virus).
Taffix reduced the amount of live by more than 99%, and in most experiments, no virus was detected or the amount of virus present was below the limit of detection of the assay in the undiluted flow through. Using qRT-PCR techniques Taffix treatment reduced the amount of viral RNA by more than 4 logs.
Another used MDCK cells — routinely used to measure the cell damage caused by influenza viruses — and compared Taffix with a commercially available HPMC gel with a pH of 6.8, making it virtually neutral. A saline solution was also used to provide control.
All three samples were infected with the H1N1 virus, better known as Avian Flu, and the number of viable MDCK cells was measured at 5 minutes and 30 minutes. At 5 minutes, only 35% of the cells treated with the commercially available gel neutral pH were viable, compared to 89% with Taffix. By 30 minutes, only 47% were viable, compared to 90% in the Taffix sample.
REAL LIFE PROOF OF EFFICACY
The ultra-orthodox city of Bney Brak, has the highest rates for COVID-19 infection in Israel, so Rosh Hashana — the Jewish New Year which involves two days of seven hours of prayers — was always likely to be a super-spreader event.
In mid-September 2020, just ahead of the celebrations, 17.6% of people tested in Bney Brak were positive for COVID-19 and a fortnight later, this had almost doubled, to 28.1%.
In a prospective study, 243 members of this high-risk community, were offered Taffix and asked to use it, according to the instructions and alongside masks, during the two days of prayer, and for the following 14 days. In all, 81 people used it regularly, as instructed, 160 chose not to use the spray and two used it rarely, if at all.
After two weeks, only 2.4% of the Taffix users had caught COVID-19, compared to 10% of those who had not used the spray — a reduction of 78%. Over the same period, the infection rate across the city jumped by 60%. No side effects were reported.
Lead researcher, Professor Barbara Mann, says: “To our knowledge, this is the first time that any measure to prevent infection in COVID-19, beyond the use of masks, was proven effective.
“Given the excellent safety profile of Taffix and its statistically significant efficacy in preventing infection following what is defined as high-risk infection event — it seems that this additional layer of protection can significantly reduce the risks of infection and may enable people to resume some part of their daily routine more safely.”
Dr Meggido adds: “We all welcomed the recent news that we will soon have one, if not several vaccines, against COVID-19. But it will be some time before enough people are vaccinated to protect our communities, so it is likely to be a long and difficult winter and spring 2021.
“In addition, Taffix is nonspecific protection against respiratory viruses and as such will have an important role in preventing the annual influenza spread and other viruses that might threaten us.”
“In the meantime, Taffix helps to provide a safe, simple and clinically proven way to dramatically reduce the risk of catching COVID-19.”
Taffix is available to buy online here or at Amazon.