GOTHENBURG, Sweden,
June 11, 2021 /PRNewswire/ -- Vicore
Pharma Holding AB (publ) ("Vicore"), a rare disease pharmaceutical
company developing innovative medicines for fibrotic lung disorders
such as idiopathic pulmonary fibrosis (IPF), today announces that
the U.S. Food and Drug Administration (FDA) has accepted the
Investigational New Drug (IND) application for the company's lead
asset, the orally available angiotensin II type 2 receptor (AT2R)
agonist C21, for the treatment of COVID-19. The active IND enables
initiation of US sites in Vicore's pivotal phase 3 trial,
ATTRACT-3.
ATTRACT-3 trial is a randomized, double-blind,
placebo-controlled, multinational, phase 3 trial that will include
600 adult patients hospitalized with COVID-19 requiring oxygen
support but not mechanical ventilation. The primary objective is to
evaluate the effect of C21 on recovery from COVID-19. Vicore's
Phase 2 trial (ATTRACT) in COVID-19 showed that C21 significantly
reduced the extended need for supplemental oxygen therapy,
indicating faster recovery on C21 compared to placebo.
In ATTRACT-3, patients will be randomized to receive 100 mg C21
or placebo twice daily on top of standard of care (SoC) for 14 days
and patients will be followed for 60 days. Trial preparations are
currently ongoing in countries in North
America, South and Central
America, Europe,
Africa and Asia. Topline results from ATTRACT-3 are
expected during the first quarter of 2022.
"Morbidity and mortality in COVID-19 are still significant,
particularly in moderate to severe disease, and our earlier trial
indicates that C21 has the potential to improve respiratory
outcomes and promote recovery in these patients," said Carl-Johan Dalsgaard, CEO of Vicore. "The FDA's
acceptance of our first IND with C21 represents an important
milestone in preparing our global phase 3 trial."
C21 in COVID-19 – improved respiratory outcomes
Results from the phase 2 ATTRACT study on 106 hospitalized
patients with COVID-19, showed a significantly reduced risk for the
need of supplemental oxygen (90% compared to placebo at day 14;
P=0.003) and numerically fewer deaths and cases of patients
requiring mechanical ventilation.
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 idiopathic pulmonary
fibrosis (IPF) lung slices and a phase 2 proof-of-concept study in
IPF is currently ongoing. Given that AT2R agonism has therapeutic
potential in several additional indications with significant unmet
medical needs, Vicore has intensified the efforts to develop
proprietary follow-up molecules with differentiated profiles.
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
June 11, 2021 at 08.00
CET.
This information was brought to you by Cision
http://news.cision.com
https://news.cision.com/vicore-pharma-holding-ab/r/vicore-announces-fda-acceptance-for-pivotal-phase-3-trial-of-c21-in-covid-19,c3365181
The following files are available for download:
https://mb.cision.com/Main/15668/3365181/1430614.pdf
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Vicore announces FDA
acceptance for pivotal phase 3 trial of C21 in COVID-19
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