View all newsletters
Receive our newsletter – data, insights and analysis delivered to you
  1. News
September 23, 2021

pHOXBIO’s nasal spray prevents SARS-CoV-2 infection in Phase II/III trial

Nearly 13.1% of subjects in the pHOXWELL arm were tested positive for Covid-19 versus 34.5% in the placebo arm.

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.

Related Companies

Free Report
img

Reshape regional strategies to navigate global uncertainties

The COVID-19 crisis triggered one of the worst peacetime recessions globally. Even as several economies tread the path to recovery, the surge in COVID-19 cases and emergence of new variants, coupled with geopolitical tensions, will continue to cloud the global outlook.  The Global Risk report uses GlobalData’s proprietary Country Risk Index to determine the existing and future level of global risk by assessing over 50 key indicators, including:  
  • Macroeconomic 
  • Political 
  • Social
  • Technological 
  • Environmental 
  • Legal 
Use our Country Risk Index scores to help you understand future global risk and determine your business strategies, growth plans and investment portfolios. 
by GlobalData
Enter your details here to receive your free Report.

NEWSLETTER Sign up Tick the boxes of the newsletters you would like to receive. Key drug pipeline and competitive landscape changes based on the latest clinical activity, sent every Tuesday. Curated analysis and data-driven insights on clinical trials strategy and operations, sent every Thursday. The pharmaceutical industry's most comprehensive news and information delivered every month.
I consent to GlobalData UK Limited collecting my details provided via this form in accordance with the Privacy Policy
SUBSCRIBED

THANK YOU