pHOXBIO aims to start a UK-based Phase I trial of its preventive Covid-19 nasal spray before the end of the year, CEO Rakesh Uppal says. The nasal spray, called pHOXWELL, is designed to offer six-to-eight hours of protection from a SARS-CoV-2 infection following two puffs in each nostril.
After a positive Phase II/III trial of pHOXWELL staged in India, the London-based biotech is in conversations with UK regulators to begin the Phase I safety-focused study, Uppal says. If the trial is a Phase Ib set-up, which initial regulatory discussions have suggested, it could recruit just shy of 50 subjects, and also look at some early efficacy signals, Uppal says. Otherwise, it would likely recruit around 20 volunteers in a Phase Ia design.
In the India-based Phase II/III trial of 648 unvaccinated healthcare workers, pHOXWELL reduced SARS-CoV-2 infections by 63% relative to placebo, the company reported in September. pHOXWELL is designed as a supplement, and not a replacement, to existing COVID-19 preventive measures such as Covid-19 vaccines and personal protection equipment, says pHOXWELL researcher Angela Russell at the University of Oxford.
pHOXWELL is composed of a solution that mimics the fluid surrounding healthy cells, mixed in combination with natural virucides, Russell explains. “It both kills the SARS-CoV-2 virus directly and protects the cells against viral entry,” she says.
More trials planned
Following the planned Phase I, pHOXBIO is contemplating two additional UK-based studies: a human challenge trial and a large-scale efficacy trial that would recruit university students, Uppal says. Russell would also like to investigate pHOWELL’s ability to prevent Covid-19 transmission, as its mechanism is likely to block viral spread.
Outside of the UK, pHOXBIO is currently applying for market authorization of pHOXWELL in India, Uppal says. Once this is secured, pHOXBIO aims to establish marketing authorization in around 40 countries with similar regulatory frameworks as India in other parts of Asia, Africa, South America, and the Middle East.
As a result, pHOXBIO is in active discussions to select a global manufacturing and distribution partner with a strong footprint in these regions, Uppal says. The company will also knock on doors of major public health organizations, such as NGOs and the Gates Foundation, for further help in researching and deploying its preventive spray, he adds.
“pHOXWELL is relatively easy to make, transportable at room temperature, has a long shelf-life, and can be manufactured locally in many geographies,” Uppal says. “That has been our biggest driver in development.”