- 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.
STOCKHOLM, Oct. 25, 2021 /PRNewswire/ -- 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-32 was 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 charityLifeArc - 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
1NCT04452435
2NCT04880642
This information was brought to you by Cision
http://news.cision.com
https://news.cision.com/vicore-pharma-holding-ab/r/lancet-s-eclinicalmedicine-publishes-phase-2-data-on-c21-in-covid-19,c3438937
The following files are available for download:
https://mb.cision.com/Main/15668/3438937/1485304.pdf
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Lancet’s
EClinicalMedicine publishes phase 2 data on C21 in
COVID-19
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