Investigational treatment may reduce need for a ventilator for hospitalised COVID-19 patients

An oral treatment may reduce the need for oxygen therapy and speed recovery of hospitalised COVID-19 patients.

Early findings from the ATTRACT trial – led by an academic-pharma collaboration between Vicore and UCLH and UCL supported by staff from the Joint Research Office and Translational Research Office and part funded by LifeArc – have been encouraging and have led to a larger trial in which 600 patients will receive the treatment.

The results of the initial findings are published in EClinicalMedicine, published by The Lancet.

The treatment developed by Vicore, called Compound 21 (C21), is a type of drug known as an angiotensin II type 2 receptor (A2TR) agonist. C21 is being tested as a possible treatment for a lung condition known as Idiopathic Pulmonary Fibrosis (IPF), to reduce inflammation and thickening of the lung tissue that can occur in patients with IPF.

C21 was used in the ATTRACT trial for its potential to reduce lung inflammation in patients with COVID-19

106 patients took part in the ATTRACT study between July and October 2020 at eight hospitals in India. These patients had signs of acute respiratory infection but were not on a ventilator and were randomly assigned either to receive C21 or not in addition to their usual care.

Patients receiving C21 were given twice daily doses of 100mg orally for 7 days. During hospitalisation, patients were assessed daily on a variety of measures including need for oxygen via a ventilator to help with their breathing.

By day 14, fewer patients needed additional oxygen, with just one patient out of 51 (2%) in the C21 group still needing oxygen compared with 11 patients out of 55 (20%) in the placebo group. The results suggest C21 can help to restore functioning of the lung and normalise gas exchange.

The principal investigator of the study was Professor Jo Porter, consultant in respiratory and general medicine at UCLH and a professor in respiratory medicine at UCL. Clinicians and researchers at UCLH and UCL were key to developing the clinical study design for testing of C21 in COVID-19.

The research team said if the apparent beneficial effects of C21 are reproduced in the larger trial, known as ATTRACT-III, the treatment has the potential to contribute significantly to the therapeutic options for C-COVID-19. Results from the larger study are expected in 2022.

Vicore Pharma is developing C21 for the treatment of the lung condition idiopathic pulmonary fibrosis (IPF) and for treatment of COVID-19

A trial of C21 in IPF – led by another academic-pharma collaboration between Vicore and UCLH and UCL – had been planned since before the pandemic.

When the pandemic began and the potential of C21 to treat COVID-19 was recognised, the researchers at Vicore and UCL worked quickly to put a trial in place.

Prof Porter said: “We saw a marked reduction in the need for oxygen at day 14 in patients who received C21, and these findings suggest the treatment may speed up recovery time for patients hospitalised with COVID-19. These phase 2 findings bode well for the phase 3 portion of the trial which is now underway.”

The ATTRACT study received £1.5 million in funding from the UK charity LifeArc. In March 2020 the charity launched a £10 million fund to support research and testing of therapeutics that could be rapidly deployed to help address COVID-19.

Dr Catriona Crombie, head of the LifeArc Philanthropic Fund, said: “Early in the pandemic we recognised that repurposed medicines offered the fastest route to patients help address COVID-19. We were excited by the promise of this study, which has helped to identify a potential new treatment that restores lung function and speeds up recovery time in seriously ill patients.”

Dr Rohit Batta, CMO of Vicore Pharma, said: “We are incredibly pleased to be able to share these results through a prestigious publication, and we are most thankful for the support from UCL and LifeArc.”