Type: Glucose kinase (hexokinase 4) activator shown to reduce plasma glucose levels in a dose-dependent fashion, with a rapid onset of action, in normo-glycaemic insulin resistant rats and diabetic mice, when dosed acutely and when dosed once daily for up to 28 days.
Status: The U.K.’s Medicines and Healthcare products Agency (MHRA) said August 25 that it approved the Phase II ARCADIA trial (NCT04516759), designed to assess the safety and efficacy of AstraZeneca’s AZD1656 in 150 patients with either Type 1 or Type 2 diabetes, hospitalized with mild-to-moderate COVID-19.
AstraZeneca agreed to provide AZD1656 for the trial, to be led by professor John Martin and colleagues at the UK biomedical research charity St George Street. The charity, scientific intellectual property, professionals, and international funding was assembled and structured by professor Sir Chris Evans, chairman and CEO of Excalibur Healthcare Services, through a new entity, Excalibur Medicines.
ARCADIA will commence with Evans and the Excalibur team having sourced investment from Mubadala, an Abu Dhabi-based global investment firm, Excalibur itself and several high net worth individuals. This is in addition to funding secured from the U.K. Government through the UKRI / Innovate UK programme. This enables the trial to go ahead at speed in 150 patients over a four month timeframe at multiple sites in the U.K.
AZD1656 was originally developed for use in treatment of hyperglycemia in patients with Type 2 diabetes mellitus. Excalibur envisions AZD1656 being used for treating people with diabetes who have early symptoms of COVID-19, since the drug is designed to dampen the overactive response of the immune system typically acute in patients with raised blood glucose levels. Those patients are at higher risk for the virus, since diabetes is the leading single cause of co-morbidity with COVID-19, according to the MHRA.
According to the NIH’s National Center for Advancing Translational Sciences (NCATS), AZD1656 has been studied alone and in combination with other blood glucose control agents in diabetic patients. Three Phase IIa studies have been conducted up to 90 mg BID for 28 days (monotherapy, add-on to metformin, add-on to insulin) and two Phase 2b trials of four months duration. AZD1656 has been demonstrated to effectively lower blood glucose levels in human trials.
COVID-19: 200 Candidates and Counting
To navigate through the >200 potential therapeutic and vaccine options for COVID-19, GEN has grouped the candidates into four broad categories based on their developmental and (where applicable) clinical progress:
● FRONT RUNNER – the most promising therapeutics/vaccines based on clinical progress, favorable data or both.
● DEFINITELY MAYBE – earlier phases with promising partners, or more advanced candidates in development that have generated uneven data.
● KEEPING AN EYE ON… – interesting technology, attracting notable partners, or both, but preliminary data.
● TOO SOON TO TELL – longshots pending additional experimental and/or clinical data.
GEN has also tagged the most common treatment types: