SoftOx Solutions has announced that a Phase 1 study of its SoftOx inhalation solution (SIS) demonstrated that nebulized SIS was well tolerated with no serious adverse effects observed and no adverse effects related to pulmonary function. The study enrolled 57 healthy volunteers who got either SIS or placebo delivered via jet nebulizer 4 times per day for 5 days, with the SIS at concentrations of up to 100 µg/ml HOCl. The company said that it is now making preparations to advance the inhalation solution into SoftOx Phase 2 development.
According to the company’s website, “The SoftOx . . . approach to the development of an antimicrobial solution is to investigate naturally occurring chemicals that harbor broad antimicrobial effects without inducing resistance. The broad spectrum antimicrobial effect includes active and dormant bacteria, viruses, yeast, fungi and spores, including bacteria within their protective biofilm environment. Our primary focus is to combat the 12 pathogenic bacteria that pose the greatest threat to human health (as addressed by WHO). There is also emphasis on supporting the fight against viral epidemics / pandemics, caused by coronaviridae (such as MERS-CoV, SARS-CoV-1and SARS-CoV-2), Influenza virus, Ebolavirus, Norovirus, Poliovirus, and others.”
SoftOx Chief Medical Officer Christopher Burton said, “We are highly encouraged by these Phase 1 results demonstrating an acceptable safety and tolerability profile for a potential future inhaled antiviral treatment. This study paves the way forward for the future clinical development of SIS within infectious disease indications in the upper and lower respiratory tract.”
CEO Geir Almås commented, “SIS has the potential to be a breakthrough in respiratory treatment. The broad spectrum antimicrobial effect of SIS obviates the need for expensive diagnostic testing which can also delay the start of treatment, and would represent a paradigm shift in the management of respiratory infections.”
Read the SoftOx Solutions press release.
