TAFFIX: FAST SCIENCE SUMMARY

Introduction

Coronavirus disease 2019 (COVID-19) is a respiratory illness that results from infection with
Severe Acute Respiratory Syndrome coronavirus 2 (SARS-CoV-2)1. The disease has been
detected in most countries worldwide and community spread is being detected in a growing
number of countries. On March 19 2020, the COVID-19 outbreak was characterized as a
pandemic by the World Health Organization - WHO.

Early reports suggested that person-to-person transmission most commonly happens during
close exposure to a person infected with COVID-19, primarily via respiratory droplets produced
when the infected person coughs or sneezes. Droplets can land in the mouths, noses, or eyes
of people who are nearby or possibly be inhaled into the lungs of those within proximity.

The main means we have of helping to prevent a COVID-19 infection are wearing masks,
washing hands frequently and keeping our social distance from people outside of our
households. The measures, together with all government guidelines and regulations, should be
strictly adhered to.

Whilst these physical measures reduce transmission, other means of blocking viral entry into
the airways would be welcome.

• Taffix is a new personal nasal powder spray that blocks and kills up to 99% of viruses (e.g.,
SARS-Cov-2, the virus that causes COVID-19) in the nasal cavity

• Taffix is the first of its kind nasal powder spray that creates an active HPMC (Hydroxypropyl
Methylcellulose) gel barrier over the nasal mucosa and lowers its pH (to a pH of 3.5)

• Taffix acts within 50 seconds and provides respiratory virus protection for 5 hours

Why target the nasal cavity? The Science

Recent research has identified the nose as the main entry point for the COVID-19 virus. In
people with COVID-19 infection nasal swabs have yielded higher viral loads (higher amounts of
virus) than throat swabs implicating the nose as the main gateway to infection and transmission
of the COVID-19 virus 1. Of note also is that a major symptom of COVID-19 is loss of smell 2.

Research published this year in Nature Infection and conducted by scientists in Cambridge, UK
has identified specific nose cells as likely COVID-19 virus entry points 3. The specific nasal cell
cells identified in this research are the goblet cells and the cilia cells.

The nasal goblet cells produce mucin (a type of protein that provides the molecular framework
for mucous). The goblet cells rapidly produce and discharge mucous in response to a variety of
biological stimuli, including smoke and dust, viruses and bacteria.

1 Zhou P et al (2020). https://www.nature.com/articles/s41586-020-2012-7

2 Sayin I & Yazici ZM (2020) https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7328466/
3 Sungnak W et al (2020) https://www.nature.com/articles/s41591-020-0868-6

LBL-0024-EU
Cells of the nasal cilia are also implicated in facilitating entry of the COVID-19 virus. The nasal
cilia are fine, flexible structures that waft or beat to clear the nasal cavity of mucous.

These nasal cells are an important part of the immune system and act as the central component
in the defense against respiratory pathogens through the combined functions of creating a
physical barrier in the nose and contributing to both innate and adaptive immunity.

When these nasal cells are working effectively, the physical barrier and immune activity prevent
viruses from entering the airways, including the lungs and hence the rest of the body.

The COVID-19 virus depends for its entry into the body on the binding of its viral spike protein to
a specific cell receptor. The viral spike protein is then primed by cell enzymes known as
proteases. The main cell receptor to which the spike protein binds is Angiotensin Converting
Enzyme (ACE) 2. 4 The binding affinity of the COVID-10 spike protein for the ACE2 receptor is a
key factor for COVID-19 virus replication and disease severity. 5 The research published in
Nature Infection found that the goblet cells and cilia cells in the nose are richer than any other
cells in the body with the specific ACE 2 receptors to which the COVID-19 virus binds

Why is low pH within the nasal cavity important for killing viruses?

Low pH strengthens the nasal barrier and creates a hostile environment for viruses. 6 Research
has shown that several respiratory viruses are sensitive to and inactivated (or killed) by low pH
(an acidic environment). 7,8,9 This is thought to be due to changes in viral proteins caused by the
acidic conditions. One laboratory study found that the stability of coronavirus 229E was maximal
at a pH of 6 (almost neutral pH) 10 with significant reduction of coronavirus 229E infectivity at a
pH below 4. Further research found complete inactivation of rhinovirus at pH 3 11.

What is Taffix?

Taffix is an innovative nasal powder containing the well-established pharmaceutical ingredient

Hydroxy Propyl Methyl Cellulose (HPMC) which, when subject to specific manufacturing
technology and sprayed into the nose, creates a patented, thin, uniform gel over the nasal
mucosa. This gel lowers the pH of the nasal cavity to 3.5 where up to 97% of all viruses are
rendered inactive. Use of Taffix adds a significant protective tool for preventing viral infections
in addition to the essential preventive measures recommended during the current
pandemic.

Wearing a mask, washing hands and keeping your distance are essential. Use of Taffix does
not reduce the need for these essential measures but adds additional protection.

4 Sungnak W et al (2020) https://www.nature.com/articles/s41591-020-0868-6

5 Hoffmann M et al (2020) https://pubmed.ncbi.nlm.nih.gov/32142651/
6 Rennie P et al (2007) https://respiratoryresearch.biomedcentral.com/articles/10.1186/1465-9921-8-38

7 Rennie P et al (2007). https://respiratory-research.biomedcentral.com/articles/10.1186/1465-9921-8-38

8 Giranda V et al (1992). https://www.pnas.org/content/89/21/10213

9 Hambling MH (1964) https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2093680/

10 Lamarre A & Talbot P (1989). https://pubmed.ncbi.nlm.nih.gov/2819602/

11 Hughes JH et al (1973) https://journals.sagepub.com/doi/abs/10.3181/00379727-144-37634

2
Why HPMC?
HPMC is a well-established inert, viscoelastic polymer used in eye drops (Hypromellose) as well
as a component to facilitate the controlled delivery of ingredients in oral medications. In the
case of Taffix, innovative manufacturing technology is used to generate a patented thin uniform
gel over the nasal mucosa when the product is sprayed into the nostrils. The gel lowers the pH
of the nasal cavity to 3.5 where up to 97% of all viruses are rendered inactive.
In short, this technologically created patented gel that physically prevents viruses from
reaching the nasal cells.

Taffix: Science Technology Spotlight

Taffix™ is based on unique microsphere technology that generates small uniform particles
which create an even thin gel. Acidification of the gel is a complex chemical process ensuring
uniformity of the delivered dose.

The manufacturer has patented technology that can create homogenous, uniform microspheres
with small particle size and in a very narrow range of size. This technology has been used to
develop an HPMC powder that has inherent advantages over the HPMC used in currently
available products.

The smaller particle size creates a higher surface area and better spraying properties. The
particles are distributed more homogeneously forming a more even and uniform gel layer. This
physical advantage has clinical consequences since the gel layer is the protective layer that
should block small particles and viruses from reaching the nasal epithelial cell level.

Compare this technology with that of commercially available HPMC powders which, due to
irregular micro particles with a wide particle size distribution, do not deliver a uniform product.
Creation of an uneven gel in the nose may expose the underlying nasal epithelium to viruses or
other environmental hazards thus reducing the efficacy of the treatment.

In addition, the Taffix technology enables each particle in Taffix formulations to contain ALL
ingredients of the formulations. In other words, every microsphere contains all components
(HPMC, Citric Acid and Benzalkonium) thus ensuring uniformity of the delivered dose. This
property clearly differentiates Taffix™ from other HMPC containing nasal powders, which are
simple mixtures of milled polymers and other materials.

Studies using Taffix

The efficacy of Taffix in preventing viruses from infecting and killing human cells has been
tested in a series of in-vitro (laboratory) studies.

Taffix has also been tested in a real-life situation where it was found to reduce the risk of
infection in human beings when used ahead of a public gathering.

3
Laboratory studies

Taffix creates a stable gel over nasal mucosa

In an ex vivo test in pig’s nose 46mg Taffix powder was sprayed into each nostril 12, showed that
the gel was created within one minute and remained intact for up to 6 hours. The pH was
measured in situ and found to be 3.6 as soon as the gel was created at 4.4 to 6 hours.

The findings from this study suggested that Taffix should be re-applied before entering a
crowded area and every 5 hours after whilst in the crowded area.

Taffix is able to protect cells against infection of SARS-Cov-2 virus

A study conducted at the University of Virginia Department of Medicine and Division of

Infectious Diseases and International Health by Professor Barbara Mann 13 tested whether Taffix
can form a protective barrier specifically against the COVID-19 (Sars-CoV-2) virus.

This was a laboratory study in which a gel of Taffix created on a 40nm nylon filter to which
10,000 plaque forming units (PFUs) of the Sars-CoV-2 virus was added. (PFU is a measure of
the number of infectious virus particles. A filter untreated with Taffix but to which the same
amount of virus was added was used as a control. Standard laboratory assays were used to
test for live virus and viral RNA 10 minutes after the addition of Taffix.

Taffix reduced the amount of live virus by more than 99% and significantly reduced viral RNA by
4 logs (logarithms) (meaning a 99.99% reduction in viral RNA). In most experiments, no virus
was detected or the amount of virus present was below the detection limit of the assay.

Taffix completely blocks SARS-CoV-2 (COVID-19) virus cells infection 14

Efficacy of Taffix against COVID-19 - Quantification of virus RNA - 99.9% blockage

Well Flour Target Content Sample Cq

C02 FAM N1 Pos Ctrl plasmid 32.69

E02 FAM N1 Unkn untreated 20.25

F02 FAM N1 Unkn gel-treated 33.61

Blue - untreated well

Red - control
Green - gel treated well

The gel layer produced by Taffix powder after administration of a clinical equivalent amount,
effectively blocked SARS-CoV-2 virus, as demonstrated by reduction in virus RNA equivalent to

12 Taffix Data on File

13 Data on file
14
Barbara J Mann, G Brett Moreau, Tair Lapidot, Dalia Megiddo. TaffiX® Nasal Powder forms an Effective
Barrier against SARS-CoV-2. Biomed J Sci & Tech Res 33(3)-2021. BJSTR. MS.ID.005405.

4
4 log reduction in virus count. Taffix also protected above 99% of cells from infection by live
SARS-CoV-2 virus.

Taffix is highly effective against other respiratory viruses

Taffix was tested in a further laboratory study to evaluate the direct effect of the pH of different
Taffix formulations on the ability of H1N1 influenza virus to reduce viability of MDCK cells
(MDCK are cells commonly used in biological laboratory research) and compared to
commercially available neutral HPMC product.

MDCK cells were divided into two main groups. The first group had saline added but no virus to
act as a control). The second group of MDCK cells were infected with H1N1 influenza virus.
Prior to the infection viruses were treated either with Saline, Taffix at 3.5 pH or commercially
available HPMC product carrying a pH of 6.8. Taffix for 5 minutes and 30 minutes.

Cell viability was measured following the infection. Addition of the virus pre treated with saline to
the cells decreased their viability to 27% (a decrease of 93% when the virus was pre-incubated
for 30 minutes with saline) and to 22% (a decrease of 98% when the virus was pre-incubated
with saline for 30 minutes).

Treatment of cells with Taffix did not significantly affect the cells ’viability compared to that of the
untreated cells (no virus added). In fact, addition of Taffix to cells infected with the virus
decreased the cells ’viability only TO 89% at 5 minutes and TO 90% at 30 minutes
(compared with 100% viability of MDCK cells with no virus added)

Treatment of infected cells with a commercially available gel (pH 6.8) significantly reduced
infected cell viability TO 35 % at 5 minutes (compared with 89% with Taffix) and TO 47% at
30 minutes (compared with 90% with Taffix)

Taffix proven highly effective against respiratory viruses 15

Taffix reduces cell death caused by H1N1 influenza virus by 90%

MDCK cells were treated with H1N1 influenza virus and their viability was tested. Viruses
wWere pretreated by Taffix or saline for 5 minutes or 30 minutes prior to infection.

15
Taffix data on file

5
.

Taffix effectively protects cells from infections of lentivirus

In this study the efficiency of the Taffix gel formulation to act as a barrier was tested.
The gel was formed in a cell strainer made from nylon neck with 40-micron holes.
The aim was to see if an infective virus (lentivirus in this case) can pass through the cell strainer
treated with Taffix. The results of the study indicate that 97% of lentiviruses were not able to
cross the Taffix gel and infect cells.

Taffix proven highly effective against respiratory viruses 16

Taffix protects cells from lentivirus infection by 97%

Cell without protection Cell protected with Taffix

Fluorescence spots = Almost no Fluorescence is

virus infection in cells, as seen = no virus reached
seen under microscope the cells

Fluorescence measurement in cells treated with test

solutions. GFP lentivirus was used based on its ability to
insert a GFP fluorescent gene into infected cells thus
enabling the identification of virus-infected cells.

Taffix reduced COVID-19 virus infection risk by 78% when used ahead of a public gathering 17

This was a prospective user survey involving human beings in the city of Bney Brak, Israel,
(population 210,000 mostly ultra-orthodox Jews) which has the highest COVID-19 infection rate
and mortality in Israel. In mid-September before the Jewish New Year (an intensive two day
gathering for prayers) findings from the PCR (polymerase chain reaction) test for COVID-19
found the proportion of people testing positive was 17.6% and those climbed to 28.1% two
weeks later. (The PCR test looks for evidence that the virus is currently in the body, by
detecting the presence of viral RNA in a swab sample from the nose/throat).

In this study, 243 members of a Jewish ultra-orthodox synagogue community in Bney Brak that
participated in the two-day Jewish New Year prayer gatherings (involving 7 hours spent daily in
the synagogue) were followed up for the following 14 days to measure the effect of Taffix in this
potentially “super spread” event. A total of 83 participants collected and used Taffix throughout
Rosh Hashana prayers and for the following two weeks (intention to treat group, ITT), 81 of
them used it regularly as instructed (per protocol, PP) while two used it rarely if at all. The

16 Taffix data on file

17
https://www.researchsquare.com/article/rs-100328/v1

6
 remaining 160 participants did not use Taffix.

At the end of the two weeks follow up results in the ITT group were as follows:

• Of the 83 people who used Taffix two (2/83 or 2.4%) were infected with COVID-19 virus

• Of 160 people who did not use Taffix 16 (16/160 or 10%) were infected with COVID-19 virus

• The odds ratio for SARS-CoV-2 infection in Taffix users was 0.22 (p=0.028), a reduction of 78%
(95%CI 1%-95%) in odds of infection.

• No side effects were reported.

These findings demonstrate that Taffix can be a helpful tool (in addition to masks, hand
washing and social distancing) against COVID-19 spread.

Taffix reduces risk of infection in real life super spread event. (odds ratio 0.22, p=0.028)

Number of Rate of
Groups
Infected people infection
81 people from the community –
Used Taffix Regularly, Up to 3 times a day, before
0 0%
Taffix meeting people and before praying on Rosh
Users Hashanah and kept all recommended measures

2 more people from the community-

2 2.4%
Used Taffix Irregularly

160 people from the community-

Taffix Non
did not use Taffix and in those who kept all 16 10%
Users
recommended measures

*2 weeks later - Taffix reduces SARS-CoV-2 infection

" The fact that Taffix was able to significantly reduce infection rate in users of the product is very
encouraging. It may offer an additional layer of protection to people who encounter events that
pose high risk of infection. The data contributes to our knowledge of the effect on population

7
 protection. Additional controlled clinical studies will be needed to deepen our understanding of
the specific efficacy in different circumstances“
— Prof Y. Naparstek, from the Hadassah Medical Center, Jerusalem Israel, and the Scientific Director of Meuhedet HMO
Research Institute In Israel

Safety of HPMC nasal powder

HPMC is inert, stable and safe. It is widely used and recognised in the European Union (EU) as
a food additive and recognized as GRAS (generally Regarded as Safe) by the US Food and
Drug Administration (FDA) 18.

HPMC nasal powder has been in use in Europe and the US for nearly 20 years (Nasaleze™).
This product has been classified as a class 1 medical device in Europe and a Class 2 medical
device by the FDA and is approved for sale in Israel. In over 20 years of use, over 7 million
products were sold and demonstrated a complete safety profile. Almost 30 clinical studies were
performed with this product consolidating its safety profile 19. In the latest safety study published
in April 2020, no pathological changes in the respiratory tract following treatment with HPMC
were found in a laboratory study 20 .

Safety of low pH nasal formulations

A number of nasal sprays with a pH of 3.5 have regulatory approval from the FDA and safety
data shows them to be safe and well tolerated 21.

Regulatory approval
Taffix is legally marketed in Europe (CE-DE/CA09/0760/N18/001) and indicated for use as a
protective mechanical barrier against allergens and viruses (e.g., SARS-CoV-2) within the nasal
cavity. Taffix is intended for over the counter (OTC) use.

When to use Taffix

• Use Taffix before exposure to high-risk environments where environments may be airborne
(such as shops, supermarkets, pubs, bars, restaurants and other places where people gather)
or when you encounter anyone from outside your household.

• Taffix may be used up to 3 times a day (whilst in a risky environment) to maintain an effective
barrier. Once applied Taffix is effective for 5-6 hours.

• Taffix contains no drugs or medicines, is non-drowsy and has a good safety profile.

Who can use Taffix?

• Taffix is suitable for adults, athletes and children over 12 years

Who should not use Taffix?

18 Burdock GA (2007) https://pubmed.ncbi.nlm.nih.gov/17723258/

19 Clinical research on Nasaleze. http://allergyl.pl/wp-content/uploads/2019/04/Allergyl-Clinical-Trials-ENG.pdf
20 Popov TA, Emberlin J, Josling P, Seifalian A. In vitro and in vivo Evaluation of the Efficacy and Safety of

Powder Hydroxypropylmethylcellulose as Nasal Mucosal Barrier. Med Devices (Auckl). 2020;13:107‐.

113. Published 2020 Mar 30. doi:10.2147/MDER.S236104
21 Nasus Pharma. Taffix. Studies on file

8
• Children under 12 years (can use after consulting their physician)

• People sensitive to any of the ingredients: check the label

• Pregnant or breast-feeding women should consult their doctor before using

Cautions
• Taffix bottles should not be shared with other people. Mark your bottle and avoid sharing it with
others to prevent transmission of viruses and germs
• Very few cases of allergic reactions have been found with Taffix. Most reports received to date
include blocked nose, runny nose, sneezing, sore throat. If symptoms more severe than this are
experienced, stop using the product. If symptoms persist see your doctor.
• Tingling, burning or irritation may be experienced when you first use the product
• Avoid contact with the eyes.
• If the powder gets in your eyes, rinse the eyes well with water
• Do not use if the top has been tampered with
• Always close the top

• Do not wash the bottle with water or any other fluid as this may block the bottle
• Store at room temperature. Do put in the fridge or freezer.

Conclusion

Taffix Nasal Spray offers a safe and effective additional layer of protection (in addition to
wearing masks, washing hands and maintaining social distance) in reducing the risk of viral
respiratory infections and specifically for the current COVID-19 disease.

Taffix Nasal Spray can be used up to 3 times a day and offers protection whilst in a risky
environment for up to 5-6 hours.

Taffix uses the technology of small, narrow range particle size HMPC to create a thin, uniform
low pH gel when the powder is sprayed into the nose. This creates both a physical barrier to
viral access to the nasal cells and a low pH nasal environment in which virus survival is
significantly reduced.

This concept of effective blocking of viruses to penetrate the nasal mucosa with a low pH gel
has been described and well validated in the scientific literature as a useful means to block
respiratory virus infections with many respiratory viruses. Taffix has been demonstrated to
successfully create a low pH microenvironment in the nasal cavity and prevents viruses from
reaching the cells and infecting them.

Laboratory studies have shown that:

• Taffix creates a stable gel over nasal mucosa

• Taffix is able to protect cells against infection with COVID-19 SARS-Cov-2 virus

• Taffix is highly effective against other respiratory viruses

9
• Taffix effectively protects cells from infections of lentivirus

A study in human beings found that:

• Taffix reduced COVID-19 virus infection risk by 78% when used ahead of a - high infection risk
public gathering
How to use?

How to prepare a new Taffix for use?

• Take your Taffix Nasal Spray out of the package

• open the cap

• Shake Taffix bottle

• Test spray into the air twice

The Taffix is now ready for use

How to use the Taffix?

Every time you take Taffix follow the instructions below

Blow your nose Shake the bottle Apply 1 to 2 sprays Wipe the bottle
into each nostril

Manufacturer: Mdi Europa

Nasus Pharma Ltd. GmbH
Harakevet 29 Tel Aviv, 6618306, Israel Langenhagener Str. 71, D-30855
10
Tel: +44 20 8798 0660 Langenhagen, Germany
info@nasuspharma.com Tel: +49 511 39089530
www.taffixprotect.es info@mdi-europa.com
Registration number in in Europe (CE-
DE/CA09/0760/N18/001)
Registration number in Israel
MOH (AMAR): 33010001