Further analysis of data from the ARCADIA clinical study confirms that the addition of AZD1656 treatment to standard care resulted in fewer deaths and earlier hospital discharge in COVID-19 patients than did placebo treatment.
The ARCADIA Phase II multi-centre study was undertaken in over 150 diabetic patients hospitalised due to moderate to severe COVID-19 infection. Patients received either AZD1656 or placebo daily for up to 21 days in addition to standard care and antidiabetic medications. To be clear, all patients in the trial received standard of care treatment (over 70% in both groups received dexamethasone) with those in the drug group receiving AZD 1656 in addition. No deaths occurred in those receiving AZD1656 in the first week of treatment, whereas six deaths occurred in the placebo group. All-cause mortality rates within 28 days of admission favoured the AZD1656 patients, with only four deaths occurring, versus nine deaths in the placebo group.
Thirty patients in the AZD1656 group (38%) were discharged from hospital within seven days of admission, but only 18 patients (25%) receiving placebo treatment. AZD1656 treatment was shown to be safe and well-tolerated.
In addition to the clinical benefit observed in this high-risk patient group, the immunological data gathered from the trial strongly supports SGSC’s rationale for the ARCADIA study by confirming that AZD1656 is an immunomodulator which damps down the inflammatory response characteristic of COVID-19 infection, while enhancing the virus-specific immune response.
Thus far, only a small number of repurposed or repositioned drugs have demonstrated benefits in treating COVID-19 infection in early clinical study1. SGSC believes that AZD1656 has the potential to become a valuable addition to the very small number of available COVID-19 drug treatments, offering a safer and more effective alternative to immunomodulatory treatments such as dexamethasone and other steroids, infused anti-cytokines (such as tocilizumab) and Janus kinase inhibitors2.
AZD1656 has an important advantage over small molecule and antibody antiviral agents in that due to its immodulatory effect, efficacy is unlikely to be compromised in treating disease caused by new coronavirus variants. The highly infectious Omicron variant appears to be associated with milder disease symptoms and lower hospitalisation rates, but we may not be so fortunate with future variants. “Variant agnostic”, readily stockpiled, transported and easily administered treatments such as AZD1656 are essential for future pandemic preparedness.
1 COVID-19 early treatment: real-time analysis of 1,489 studies. https://c19early.com. Accessed 3rd Match 2022
2 NIH Covid-19 Treatment Guidelines. Table 4f. Characteristics of Immunomodulators. https://tinyurl.com/3jbeucyh Accessed 3rd March 2022
SGSC is actively engaged in commercial discussions with appropriate global and regional pharmaceutical companies, with the objective of outright sale, partnership in future development or securing funding for the additional clinical studies necessary to get this to market. Ideally AZD1656 would be evaluated in broader non-diabetic patient populations, both hospitalised patients and those at higher risk of hospitalisation due to underlying health conditions. Despite the unknowns around the evolution of the pandemic, SGSC believes that AZD1656 has the potential to generate significant long-term revenue.
The COVID-19 pandemic has been truly global, and SGSC believes that AZD1656 could be particularly valuable in countries where limited hospital resources, low vaccine uptake and a high prevalence of vulnerable individuals have conspired to push up hospitalisation and death rates.
About AZD1656
AZD1656 was originally developed by AstraZeneca as a diabetes treatment and has an extensive record of safety in clinical studies involving more than one thousand subjects. Preclinical data suggested a likely immune mode of action, leading SGSC to secure a licence to the agent as a therapy for inflammatory conditions.
In addition to the ARCADIA study supported by EML, the Mubadala Sovereign Wealth Fund, Chlodwig Enterprises and UKRI / Innovate UK, SGSC has actively built on the scope of AZD1656 through patent filing (COVID-19 combination treatment) and intends to exploit the beneficial immunomodulatory effect in immune dysfunction applications.