pHOXBIO Announces Breakthrough Clinical Trial Results Concluding Prophylactic Nasal Spray Prevents Infection from SARS-CoV-2
PR91830
LONDON and NEW YORK, Sept. 22, 2021 /PRNewswire=KYODO JBN/--
- pHOXWELL significantly reduced SARS-CoV-2 infection by 63% with tolerability
comparable to placebo in high-risk population of healthcare workers
- Novel self-administered nasal spray designed to augment existing preventive
measures for SARS-CoV-2, including PPE and vaccines
- Regulatory filing initiated in India for SARS-CoV-2 prevention claim
- Company exploring strategic alternatives to make product accessible in India
and markets worldwide to help combat ongoing COVID-19 pandemic and future
disease outbreaks
pHOXBIO Ltd. [ https://phoxbio.com/ ] today announced results from a
randomized, double-blind, placebo-controlled clinical trial which demonstrate
that pHOXWELL, its novel prophylactic nasal spray, prevented infection from
SARS-CoV-2, the virus that causes COVID-19. In a pivotal Phase 2/3 clinical
study, there were 63% fewer SARS-CoV-2 infections in high-risk healthcare
workers given pHOXWELL compared to placebo (p=<0.0001).
Logo - https://mma.prnewswire.com/media/1631530/pHOXBIO_grey_Logo.jpg
pHOXWELL [
] is a self-administered prophylactic nasal spray designed to offer a
variant-agnostic mechanism of action that provides a robust defence to inhibit
the infection processes of SARS-CoV-2. It is designed to be effective against
other airborne respiratory viruses. The product offers 6-8 hours of protection
with just two sprays per nostril, per application, and can be applied whether
in the workplace, at home or on-the-go.
Company Chairman, Professor Rakesh Uppal, Professor of Cardiovascular Surgery
at Queen Mary University of London and Director of Barts Life Sciences, says
"pHOXWELL presents a significant breakthrough. We now have an effective tool,
previously missing, to fight this pandemic. Vaccination, while absolutely
essential, is not 100% effective and it is still possible to become infected
by, and transmit, the virus that causes COVID-19. pHOXWELL is designed to offer
extra protection to vaccines and PPE, as the spray inhibits SARS-CoV-2 from
infecting the nasal mucosa, which is the primary entry point into the body.
pHOXWELL's efficacy is likely to be maintained with future mutations in the
virus".
Study Design and Results
The study was a double-blind, randomized, placebo-controlled study to assess
the efficacy and safety of pHOXWELL nasal spray in the prevention of SARS-CoV-2
infection in high-risk healthcare professionals in India. The trial was carried
out during the peak surge of the highly infectious Delta variant in India in
April to July 2021. The study was designed following approval by the
appropriate regulator. The primary endpoint was the percentage of subjects who
test positive for SARS-CoV-2 on IgGS (spike protein specific) testing over the
45 days of the study. Secondary endpoints included efficacy, safety and
tolerability measures.
The primary endpoint showed that 13.1% of subjects were IgGS positive in the
pHOXWELL arm versus 34.5% in the placebo arm (p= <0.0001). This result shows
that pHOXWELL has a significant prophylactic effect versus SARS-CoV-2 infection
when compared to placebo. These highly statistically significant results were
consistent across the two sites which recruited subjects (Site 1 17.4% vs
54.6%, p= <0.0001; Site 2 11.1% vs 23.9%, p=0.0015) and sex (male 13.6% vs
36.6%, p= <0.0001; female 12.1% vs 31.2%, p=0.0013).
The secondary endpoint looking at subjects experiencing clinical symptoms, also
shows significant results in favour of pHOXWELL, with only 17.6% of subjects
who experienced infection in the pHOXWELL arm having clinical symptoms versus
34.6% in the placebo arm (p= <0.0001). These results were consistent across sex
(male 15.3% vs 31.8%, p= 0.0001; female 21.7% vs 39%, p= 0.0048) and age groups
(18-35 26.5% vs 43.6%, p= 0.0091; 36-65 19.4% vs 36.9% p= 0.0018; 65+ 6.9% vs
33.3%, p= 0.0407).
User acceptability end points were positive, with an overall positive
experience maintained across the study. pHOXWELL also exhibited an excellent
safety profile.
648 subjects completed the study. The mean age was 40.8 years. 63.3% of
subjects were male and 36.7% female. All subjects were over 18, unvaccinated,
demonstrated not to be infected with SARS-CoV-2 at the time of entry (RT-PCR),
and not to have had any previous infections (IgG Spike protein negative). They
were treated three times a day with active or placebo prior to any possible
exposure situation to SARS-CoV-2 over 45 days. Subjects were regularly tested
by RT-PCR for SARS-CoV-2 infection, 556 had IgGS testing at the last visit and
potential symptoms and adverse events were recorded. A technical issue during
the study caused RT-PCR testing not to work for the infection end point for all
subjects, hence the use of IgGS testing.
Company Seeking To Deliver Benefits to Society
pHOXBIO and its parent company, Raphael Labs, will now initiate a regulatory
filing to support a SARS-CoV-2 prevention claim with the appropriate regulator,
based on the clinical trial data. This will allow for production and
distribution of pHOXWELL in India initially, with further territories intended
to follow as a prophylaxis against SARS-CoV-2 infections.
Professor Uppal, said "there is a pressing need globally for a prophylactic
nasal spray to help prevent infection in areas where vaccination rollout
remains inadequate in the face of the tragic human toll of this pandemic. We
are confident that our anti-COVID-19 nasal spray, pHOXWELL, will become a vital
part of the global armoury to provide an extra defensive shield to tackle the
pandemic, and we welcome forming partnerships with governments, NGOs and
manufacturers to deliver the preventative benefits of pHOXWELL".
pHOXWELL [
]is low cost, easy to manufacture, shown to have prolonged stability at room
temperature and can be transported globally. We anticipate its use will be
applicable to many populations where vaccination rates remain low and PPE is
scarce, particularly for frontline health workers. pHOXBIO [
] is seeking to evaluate opportunities that can help accelerate the delivery of
its products' benefits to society. Interested parties can contact the company
About pHOXWELL [
]
pHOXWELL [
] is a combination of natural virucides and Vita Raphael, a proprietary
solution, which work in concert to prevent viral infection. pHOXWELL is
designed to provide additional protection that complements current standards of
care in inhibiting the spread of airborne respiratory viruses, including PPE
and vaccines. pHOXWELL is virucidal and has been designed to inhibit the
infection of other airborne respiratory viruses including common and new
strains of coronaviruses, influenzas and rhinoviruses. In vitro testing
confirmed that pHOXWELL killed 90% of H1N1 (Influenza) in under 60 seconds.
pHOXWELL offers 6-8 hours of protection with just two sprays per application
and can be applied whether at home, at work or "on the go". pHOXWELL can be
used by most people, whether vaccinated or not, and is aimed at adults ages 18
and over.
Airborne Respiratory Viruses & Current Gaps
Viruses are amongst the most infectious and debilitating airborne respiratory
pathogens. Even without SARS-CoV-2's devastating impact, airborne respiratory
pathogen spread contributes to respiratory infection and cause around 4 million
preventable deaths each year. The ability of vaccines alone to control the
spread of airborne respiratory viruses is limited by significant challenges
including variable efficacy and challenges faced by emerging variants, global
supply demands and shortages in developing countries, and vaccine hesitancy and
unsuitability for some.
PPE use can be insufficient, used incorrectly or malfunction and in some areas
is poorly available. There is a significant need for an effective and safe
prophylactic that compliments vaccines and PPE.
About pHOXBIO and Raphael Labs
pHOXBIO [
] is a privately held biopharmaceutical company that is a division of Raphael
Labs. The company is developing pHOXWELL and pHOXGEN, two unique solutions
targeting prophylaxis of airborne respiratory viruses such as coronaviruses and
influenza viruses that cause some of the world's deadliest communicable
diseases. pHOXBIO products represent a scientific breakthrough with the
potential to impact public health and strengthen pandemic preparedness by
addressing substantial gaps in current control measures.
Raphael Labs is a Dublin-based privately held biopharmaceutical company with a
significant UK operation, managing a diverse portfolio of subsidiaries with
specific interests in the development and commercialization of Raphael Labs'
proprietary formulation Vita Raphael. Company subsidiaries include pHOXBIO,
which addresses respiratory diseases; pHOXMETICS, which addresses cosmeceutical
interests; pHOXHEAL, which is focused on wound care; and a research and
development arm called pHOXWORX.
Raphael Labs' scientific leadership team includes Professor Dame Kay Davies,
Doctor Lee's Professor of Anatomy, Emeritus at Oxford University; Professor
Steve Davies, Waynflete Professor Emeritus of Chemistry at Oxford University;
Alan Dunton M.D., based in Boston; Mr. Goutham K Gorti, FRCS, based in New
Jersey; Professor Aine McKnight, Professor of Viral Pathology at the Blizard
Institute, Queen Mary University of London; Professor Angela Russell, Professor
of Medicinal Chemistry at Oxford University; Dr Jim Swales, pHOXWELL's clinical
trial lead; Professor Mauro Teixeira, Professor of Immunology, Universidade
Federal de Minas Gerais, and Professor Rakesh Uppal, Professor of
Cardiovascular Surgery, William Harvey Research Institute, Queen Mary
University London, Barts Heart Centre and Director of Barts Life Sciences.
Raphael Labs is supported by Mark Timney, Graeme Bell, and Michael Blash in the
United States.
- News release ends -
Media Enquiries
Nicola Burdett (UK/ India)
nb@raphlabs.com
Matt Arrowsmith (US)
ma@raphlabs.com
Business Enquiries
Robert Beenstock
rb@raphlabs.com
partnerships@raphlabs.com
SOURCE pHOXBIO
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