Lancet’s EClinicalMedicine publishes phase 2 data on C21 in COVID-19

2021-10-25

· The trial showed that C21 reduced the need for supplemental oxygen and mechanical ventilation, indicating faster patient recovery. C21 was also found to be safe and well tolerated.
· Data encouraged Vicore to move into phase 3 with readout on-track for H1 2022.

Gothenburg, October 25, 2021 – Vicore Pharma Holding AB (publ) (“Vicore”), a rare disease pharmaceutical company developing innovative medicines for severe lung disorders, today announces that the results of the COVID-19 phase 2 trial of its angiotensin II type 2 receptor agonist C21 have been published in EClinicalMedicine, a peer reviewed clinical journal, published by The Lancet. The paper is available online via this link.

The positive results from the phase 2 trial are very encouraging and led Vicore to further investigate C21 in the currently ongoing phase 3 trial” said Göran Tornling, senior adviser to Vicore and co-author of the ATTRACT publication “We are very pleased to be able to share this important data through publication in EClinicalMedicine”.

The phase 2 trial ATTRACT1 was organized and conducted in the full heat of the 2020 COVID-19 outbreak.  Although the primary endpoint (reduction in CRP) was not different between C21 and placebo treated patients after seven days of treatment, secondary analyses of clinical outcomes strongly suggest that C21 treatment is beneficial in reducing the extended need for supplemental oxygen therapy. In this 106 patient phase 2 trial, data suggest that treatment with C21 may have reduced progression to more severe respiratory disease.

We see a continued need of efficient treatments for hospitalized patients with COVID-19. The vaccination rate is still low with only 37%* vaccinated with two doses world-wide and new mutations of the virus remain a challenge. Provided that we can confirm the positive results in the phase 3 trial, C21 has the potential to become one of these treatments in addition to antivirals” said Carl-Johan Dalsgaard, CEO of Vicore and corresponding author on the paper.

The Chief Investigator of ATTRACT was Professor Joanna Porter, consultant in respiratory and general medicine at University College London Hospitals NHS Foundation Trust (UCLH) and a professor in respiratory medicine at UCL.

ATTRACT-3, ongoing phase 3-trial in COVID-19
The pivotal phase 3 trial ATTRACT-3was approved by the FDA in June 2021 based on results from the ATTRACT trial. ATTRACT-3 is a randomized, double-blind, placebo-controlled, global, phase 3 trial which will include 600 adult patients hospitalized with COVID-19 and requiring oxygen support but not mechanical ventilation. The primary objective is to evaluate the effect of C21 on recovery from COVID-19. ATTRACT-3 is recruiting and expected to deliver top-line data in H1 2022.

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) leading to resolution and regeneration following tissue damage. The compound is currently in a phase 2 proof-of-concept trial in IPF and in a pivotal phase 3 trial in COVID-19.

LifeArc funding                         
The ATTRACT study received £1.5 million in funding from the UK charity charity
LifeArc – Coronavirus (COVID-19) Therapeutics, 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.

For further information, please contact:
Carl-Johan Dalsgaard, CEO
Phone: +46 70 975 98 63
E-mail: carl-johan.dalsgaard@vicorepharma.com

This information was submitted for publication on October 25, 2021, at 08:00 CET.

*Our world in data

1. NCT04452435

2. NCT04880642