Tiziana Life Sciences files for patent on potential Covid-19 therapy

Biotechnology company Tiziana Life Sciences has filed a provisional patent application on the combination of nanoparticle-Actinomycin D (NP-ACT D) with anti-interleukin-6 receptor monoclonal antibody (anti-IL-6R), it announced on Monday, as a potential therapy for the management of Covid-19 disease.

The AIM-traded firm said the underlying invention concepts were based on the hypothesis that a combination of an antiviral drug controlling proliferation of Covid-19, with an anti-inflammatory agent such as anti-IL-6R suppressing a possible ‘cytokine storm’, could provide immediate relief to severe cases of Covid-19.

It said actinomycin D (ACT D) is an antibiotic drug approved initially for infectious diseases in the United States in 1964, and is on the World Health Organization's ‘List of Essential Medicine’ as among the most effective medicines needed in a health system.

However, severe toxicities associated with the intravenous administration of ACT D limited its widespread therapeutic utility.

The NP-ACT D formulation, effectively controlling slow and sustained release, could overcome the severe toxicities of ACT D, Tiziana said.

Side-by-side animal studies have compared NP-ACT D with free ACT D, and reportedly demonstrated that the intravenous treatment with NP-ACT D was well-tolerated, with minimal apparent toxicities in animal models.

It said that importantly, results from another animal study comparing free ACT D side-by-side with an equivalent dose of NP-ACT D showed 0% mortality in rats dosed with NP-ACT D, compared to more than 90% mortality with free ACT D.

Still, Tiziana said that the safety and tolerability of NP-ACT D needed to be evaluated in healthy volunteers prior to any clinical studies.

“Patients infected with Covid-19 are known to develop an uncontrolled immune response, or ‘cytokine storm’, which results in excessive production of pro-inflammatory cytokines such as IL-6 and TNF-a, both of which are regarded as key drivers of chronic inflammation and are believed to be associated with severe lung damage commonly observed in patients with Covid-19 infections and acute respiratory distress syndrome (ARDS),” the Tiziana board said in its statement.

“Therefore, Tiziana believes it is possible to potentially combine TZLS-501 (anti-IL6R) with NP-ACT D to inhibit viral proliferation and to suppress inflammation in lungs to halt progression of Covid-19-mediated lung damage and death.”

At the close on Monday, shares in Tiziana Life Sciences were up 5% at 52.5p.