C21 pill shows clear and significant clinical benefit for COVID patients
9 Dec 2020
Study shows a clear and significant clinical benefit for COVID patients using an oral C21 formulation (a selective agonist of angiotensin AT2 receptors) with an excellent safety and tolerability profile. C21 was well tolerated and reduced the risk of needing oxygen and mechanical ventilation in a significant number of patients. Analysis or the study data continues.
Swedish pharmaceutical company Vicore Pharma have reported a study that shows a drug called C21 can hold back COVID-19 infection and prevent the disease from progressing to the next level.
This could provide a proven source of treatment for COVID outpatients and - when coupled with an effective vaccine – help to end the pandemic.
C21 was administered to 51 patients with a positive COVID test and signs of acute respiratory infection, while a further 56 patients with the same condition received a placebo. The study showed that the number of patients needing oxygen treatment, such as face-mask air supplies, was 40% lower for the C21 group compared with the placebo group. Four patients in the placebo group required mechanical ventilation, compared to one in the C21 group, and there was an encouraging trend for C21 reducing mortality, with three deaths in the placebo group, and one death in the C21 group.
Oxygen treatment is required when COVID infection progresses to the lower airways, where gas exchange occurs. Larger planned studies will aim to confirm that C21 can stall COVID infection in patients, and prevent their condition worsening.
ATTRACT COVID-19 trial with C21 (VP01)
The ATTRACT study was a randomised, double-blind and placebo-controlled trial investigating the efficacy of oral C21 compared with placebo in 106 hospitalised COVID-19 patients with signs of an acute respiratory infection but not requiring mechanical ventilation. Many of these patients go on to experience respiratory distress, as manifested by the need for supplemental oxygen, often leading to acute respiratory failure if the disease progresses. The need for oxygen treatment reflects progress of the infection to the lower airways where gas exchange occurs.
C21 reduced the risk of needing oxygen at the end of treatment by 40 %, an effect that was statistically significant (p=0.057) at the 10% level as predefined in the Statistical Analysis Plan.
There was a clear trend for C21 reducing number of patients needing mechanical ventilation, with four patients in the placebo group compared to one in the C21 group.
There was also a trend for C21 reducing mortality, with three deaths in the placebo group compared with one in the C21 group.
C21 was well tolerated in this population of severely sick patients.
The company will continue to analyse the data from the study and more information will be presented in due course.
“Given the nature and scale of this study, we are surprised to see such a clear and significant clinical benefit for C21”, says Carl-Johan Dalsgaard, CEO of Vicore Pharma, “and given the severity and duration of the pandemic, an oral C21 formulation with an excellent safety and tolerability profile could become an important and convenient early treatment of COVID-19, fulfilling a huge medical need. In addition, these results bode well for our ongoing study in idiopathic pulmonary fibrosis (IPF) as well as for future studies in larger indications where activation of AT2R may have a role to play”.
Dr Reema Kashiva, Principal Investigator at Noble Hospital and Research Centre, Pune, India, said: “Given the severity of COVID-19, it is encouraging to see promising clinically meaningful results such as the impact of C21 on oxygen use, suggesting potential utility of this medicine on shifting the treatment paradigm of this aggressive disease.”
Study design In the ATTRACT study (Angiotensin II Type Two Receptor Agonist COVID-19 Trial), a randomized, double-blind and placebo-controlled trial, a total of 106 hospitalized patients with a diagnosis of coronavirus SARS-CoV-2 infection (confirmed by polymerase chain reaction test) and signs of an acute respiratory infection but not requiring mechanical ventilation were recruited. The patients were randomized to receive oral treatment with C21 (100 mg b.i.d., n=51) or placebo (n=56) for seven days on top of standard of care (physician’s choice). The treatment groups were well balanced regarding age and sex. According to the currently available data, at least 100 of the 106 patients were treated with glucocorticoids.
C21, a first-in-class AT2R agonist C21 is a first-in-class orally available low molecular weight angiotensin II type 2 receptor (AT2R) agonist that activates the “protective arm” of the renin-angiotensin system (RAS). The compound has shown robust effects in human IPF lung slices, and a phase II proof of concept study in IPF has recently started. Given that AT2R agonism has therapeutic potential in a number of additional indications with significant unmet needs, Vicore has intensified the efforts to develop proprietary follow-up molecules with different profiles.
LifeArc funding The ATTRACT study received £1.5 million in funding from the UK charity LifeArc - Coronavirus (COVID-19) Therapeutics - https://www.lifearc.org/funding/COVID-19-funding-2/ - a £10 million fund launched on 20 March 2020 to support research and testing of therapeutics that could be rapidly deployed to help address COVID-19.