New Delhi: A UK based pharmaceutical firm is planning to launch an intranasal spray in India next month that significantly prevents the COVID-19 infection, the firm said on Thursday.
The firm, pHOXBIO Ltd, told UNI that it will approach India’s drug regulatory authority in October to apply for marketing authorisation of its novel prophylactic nasal spray which has been found 63 per cent effective in reducing the COVID-19 transmission.
The company will file a SARS-CoV-2 prevention claim with India’s regulatory body and intends to follow in other territories as well, the firm’s spokesperson said.
The firm also said that it will rope in a local manufacturer to produce the product in India, adding that it intends to make the intranasal spray available at an affordable cost.
“Our next step and focus is the filing for a SARS-CoV-2 claim. pHOXWELL has been developed in response to the pandemic. We are aiming to make the spray as affordable as possible and to form a manufacturing partnership in India,” a senior official from pHOXBIO told UNI.
The firm has reported results from a pivotal phase II/III clinical trial of its product, pHOXWELL.
In the trial, which consisted of 648 high-risk healthcare workers in India, those given pHOXWELL experienced 63 per cent fewer SARS-CoV-2 infections than participants given a placebo.
The trial was carried out during the peak surge of the highly infectious Delta variant in India from April to July 2021.
The data was also promising against symptomatic COVID-19, with 17.6 per cent of participants who experienced infection in the pHOXWELL arm experiencing clinical symptoms versus 34.6 per cent in the placebo arm.
According to the firm, the self-administered prophylactic nasal spray can provide six to eight hours of protection with two sprays per nostrils, per application, and can be applied whether in the
workplace, at home or “on-the-go”.
Company Chairman Dr Rakesh Uppal, professor of cardiovascular surgery at Queen Mary University of London and director of Barts Life Sciences, described the product as extra protection to vaccines and PPE.
“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,” he said.