pHOXBIO has reported data from a pivotal Phase II/III clinical trial that showed that its new prophylactic nasal spray, pHOXWELL, prevented infection from the SARS-CoV-2 virus.
pHOXWELL is a blend of natural virucides and a proprietary solution called Vita Raphael.
The self-administered spray can potentially provide a variant-agnostic mechanism of action that offers a strong defence to hinder the Covid-19 infection processes, the company noted.
The double-blind, randomised, placebo-controlled trial analysed the efficacy and safety of pHOXWELL nasal spray to prevent the virus infection in high-risk healthcare workers in India.
It was conducted from April to July 2021 when a peak rise in cases was caused by the Delta variants of SARS-CoV-2 in the country.
The percentage of participants testing positive for SARS-CoV-2 on IgGS (spike protein specific) testing over the 45 days of the trial was the primary goal.
Efficacy, safety and tolerability measures were included as secondary goals.
Data showed that subjects receiving pHOXWELL had reduced Covid-19 infections by 63% versus placebo.
Furthermore, 13.1% of subjects in the pHOXWELL group on the primary endpoint tested positive for Covid-19 as against 34.5% in the placebo group.
pHOXBIO noted that these findings showed the spray ability to offer a substantial prophylactic effect against Covid-19 versus placebo.
Only 17.6% of subjects were infected in the pHOXWELL arm having clinical symptoms as against 34.6% in the placebo group.
The nasal spray also demonstrated a favourable safety profile.
pHOXBIO chairman professor Rakesh Uppal said: “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.”
pHOXBIO and its parent company Raphael Labs plan to commence regulatory filing to support a Covid-19 prevention claim based on the trial results.
This will permit the manufacturing and supply of pHOXWELL in India in the preliminary stage, with plans to advance to additional territories as prophylaxis for Covid-19.
In a separate development, Codagenix reported that its new intranasal COVI-VAC vaccine showed promising safety and immunogenicity results in the Phase I dose-escalation trial in healthy adults.
Findings showed that the vaccine can potentially hinder virus replication in the nose.