pHOXBIO Ltd. has shared 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).
 

About pHOXWELL
 

pHOXWELL is a self-administered prophylactic nasal spray designed to offer a variant-agnostic mechanism of action that provides a robust defense 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. pHOXBIO anticipates its use will be applicable to many populations where vaccination rates remain low and PPE is scarce, particularly for frontline health workers.