iX Biopharma Ltd. announced its latest development programme, IXB-322, a novel low-dose interferon wafer (1000 IU) to be delivered sublingually for the prevention and treatment of respiratory viral illnesses, including COVID-19, influenza and respiratory syncytial virus ("RSV"). Interferons are human proteins (biologics) that serve as primary responders to coordinate the immune system against invading viruses and tumours. Many viruses including SARS-CoV-2 and influenza inhibit natural interferon production by the oral mucosa to thwart the host defence.

Clinical studies have shown that delivering low-dose interferon (1000 IU) directly to the oral mucosal surface allows interferon to exert its effect by interacting at the level of the mucosa, and elicit local protective mucosal immunity which may prevent and also treat these respiratory illnesses. Interferon is currently approved to treat various conditions including hepatitis B & C, melanoma, lymphoma and multiple sclerosis. To date, interferon has only been administered via injection at high doses (3-50 million IU) leading to unwanted side-effects due to over stimulation of the immune system.

The Company's sublingual approach avoids unwanted side effects associated with high dose administration, is non-invasive and avoids the problem of degradation with oral delivery of proteins due to the highly acidic and enzymatic environment of the gastrointestinal tract. iXB-322 utilises the Company's new WaferlogiX biologics platform delivery technology, which is designed to administer biologics such as therapeutic proteins and peptides, vaccines and cytokines. The WaferlogiX technology is modified from the WaferiX matrix technology and is designed to protect biologics from enzymatic degradation.

It incorporates muco-adhesives to enhance the release kinetics of biologics and maximise their interaction with the oral mucosa. Additionally, permeation enhancers have been integrated to improve the permeation across the epithelial membrane of the mucosa. The global interferon market has expanded following the COVID-19 pandemic to an estimated $7.5 billion in 2020 due to an increasing demand for the use of interferons along with antiretrovirals and antimalarial drugs in the treatment of COVID-19 patients.

Influenza and SARS-CoV2 viruses are still prevalent and cause significant morbidity and mortality despite widely available vaccination. Adjunctive strategies are required to minimize disease burden. Low dose interferon wafers could disrupt the market as a safe, effective and easy to use antiviral to prevent and treat viral illnesses like influenza, COVID-19 and RSV in both vaccinated and unvaccinated individuals.

The Company will be engaging with the US FDA on designing the clinical development program required to obtain pharmaceutical registration.