In the news release, pHOXBIO Announces Breakthrough Clinical Trial Results Concluding Prophylactic Nasal Spray Prevents Infection from SARS-CoV-2, issued Sept. 22, 2021 by pHOXBIO over PR Newswire, we are advised by the company that the hyperlinks have been revised. The complete, corrected release follows:
pHOXBIO Announces Breakthrough Clinical Trial Results Concluding Prophylactic Nasal Spray Prevents Infection from SARS-CoV-2
- 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
LONDON and NEW YORK, Sept. 22, 2021 /PRNewswire/ -- pHOXBIO Ltd. 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).
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).
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