Trial of 100 COVID-19 patients to test the impact of pulmonary fibrosis drug on COVID-19 progression
A randomized phase 2 placebo-controlled clinical study named ATTRACT (Angiotensin II Type Two Receptor Agonist Covid-19 Trial) to test the impact of an AT2R agonist (VP01) on progression of COVID-19 disease
Vicore Pharma, with funding from LifeArc, is set to commence Phase 2 clinical trials testing an already available drug candidate in 100 hospitalised COVID-19 patients. Researchers at Vicore Pharma, in collaboration with University College London, have identified that one of their candidate drugs VP01 (Compound 21; C21), currently also in development for pulmonary fibrosis, could reduce the severity of COVID-19 disease. It has the potential to reduce Acute Respiratory Distress Syndrome also known as severely inflamed lungs which is commonly the cause of death in severe cases of COVID-19.
University College London and Vicore Pharma
- Principal Investigator: Professor Joanna Porter, University College London
- Co-investigator: Mimi Flensburg, Vicore Pharma
Potential of repurposed therapeutic for COVID-19 pandemic
In severe cases of COVID-19, the virus causes an exaggerated degree of inflammation, a major contributor to lung damage. VP01 (C21) targets a receptor called the Angiotensin II Type 2 Receptor (AT2R) which regulates levels of inflammation. By binding to and activating AT2R, VP01 reduces inflammation through activation of the so-called “protective arm” of the renin-angiotensin system. Therefore, VP01 has the potential to limit virus-induced lung edema and injury in cases of COVID-19. VP01 is also being developed to improve lung function in idiopathic pulmonary fibrosis.
Despite this pathway link, there are no other programs or trials that are currently investigating other AT2R inhibitors for COVID-19. Given the availability of VP01, it is expected that if proven beneficial to COVID-19 patients it could be launched during the current pandemic, thus meeting the intentions of the LifeArc COVID-19 repurposing call.
LifeArc and the LifeArc COVID-19 Fund Scientific Advisory Panel reviewed existing data from previous animal and human safety studies as well as a medical review of the plan for future research. Researchers have secured funding from LifeArc to progress VP01 to a Phase 2 randomised controlled clinical trial due to the potential of the compound and clear, timely plan for its path to patients. In the Phase 2 trial, named ATTRACT (Angiotensin II Type Two Receptor Agonist Covid-19 Trial), researchers will test VP01 on 100 COVID-19 patients to see if there are significant reductions in inflammation.
Endpoints in the study include safety of VP01 in patients with moderate COVID-19 disease and efficacy of VP01 on oxygen saturation, body temperature, length of hospital stay and biomarkers of inflammation and tissue damage. The clinical trial will take place at University College London Hospitals NHS Trust as well other selected UK and non-UK sites, and is due to complete in 6 months. The Medicines and Healthcare products Regulatory Agency (MHRA) has given Vicore Pharma approval to commence phase 2 clinical trials, which means that testing in patients should be imminent.
Progress update – November 2021
A total of 51 patients received C21 twice daily for seven days in addition to standard of care, while a further 55 received a placebo in addition to standard of care. After 14 days of starting the treatment, one of 51 (2%) patients in the C21 groups required additional oxygen on a ventilator compared with 11 of 55 (20%) in the placebo group. These encouraging results, reported in EClinicalMedicine published by The Lancet, suggest that C21 may reduce the need for oxygen therapy and speed recovery of hospitalised patients with COVID-19.
The researchers will now conduct a phase 3 clinical trial involving 600 hospitalised patients to evaluate the safety and efficacy of C21. The results of the ATRACT-III study are expected in 2022.