GTEBORG from Sweden, November 2, 2021 / PRNewswire / – Vicore Pharma Holding AB (publ) (“Vicore”), a rare disease pharmaceutical company that develops innovative drugs for severe lung disorders, today announces results showing that treatment with the AT2R C21 agonist of company reduces long-term lung injury in hospitalized COVID-19 patients.
The new results are based on high resolution computed tomography (HRCT) scans from a 3 to 6 month non-interventional retrospective follow-up trial, ATTRACT-22. This study included a subset of 33 patients with COVID-19 participating in Vicore’s Phase 2 ATTRACT trial3. The patients treated with C21 (n = 17) had reduced pathological abnormalities compared to the group treated with placebo (n = 16); in the C21 group, on average 10.3% of the lungs were affected compared with 19.2% in the placebo group. The dominant radiological change was the opacity of the ground glass, a pathological feature following viral respiratory infection. Although functional tests were not performed in this study, it is known that reduced gas exchange is a common abnormality of lung function in COVID-19 patients with abnormal HRCT at three months.
“These promising results are encouraging news for patients and physicians involved in Vicore’s ATTRACT-3 phase 3.4 test in COVID-19 and suggests that C21 has the potential to speed recovery after COVID-19. It also indicates that the lasting injury some patients experience after severe COVID-19 may be improved by treatment with C21.” noted Elin Rosendahl, Vice President of Clinical Development at Vicore Pharma.
Lung injury scores were assessed by an independent, blind radiologist experienced in HRCT scanner reading at a national center for chest disease in the UK. The scores were cumulative totals for the types of conventional lung injury commonly assessed by radiologists. Follow-up HRCT scans were recorded as part of local clinical practice during follow-up visits made 90-170 days after the 7-day treatment period in the ATTRACT trial in patients who received either C21 or placebo in addition to standard processing. care including steroids and the antiviral remdesivir. To our knowledge, this is the first time the effects of a pharmaceutical intervention on long-term lung damage have been reported after COVID-19 has been reported.
The results of the ATTRACT trial were recently published in EClinicalMedicine, a peer-reviewed clinical journal published by The Lancet, and are available online through this connect. The randomized, double-blind, placebo-controlled trial showed that C21 in addition to standard care significantly reduced the proportion of COVID-19 patients requiring supplemental oxygen, indicating faster patient recovery compared to placebo.
ATTRACT-3, Phase 3 COVID-19 trial underway
The design of the pivotal phase 3 ATTRACT-3 trial was approved by the FDA in June 2021 and is currently recruiting patients in the United States, Czech Republic, Ukraine, India, South Africa, and Philippines. ATTRACT-3 is a randomized, double-blind, placebo-controlled, global phase 3 trial that will include 600 adult patients hospitalized with COVID-19 requiring oxygen support but no mechanical ventilation. This is a different category of patients from those targeted by antivirals. The main objective is to assess the effect of C21 on recovery from COVID-19. ATTRACT-3 is expected to provide top-notch data in the first half of 2022.
C21 – a first class AT2R agonist
C21 is an orally available, first-in-class, low molecular weight angiotensin II type 2 (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 the IPF5, and in a pivotal phase 3 COVID-19 trial.
The ATTRACT study received £ 1.5million in funding from the UK charity LifeArc – Therapeutics against the coronavirus (COVID-19), a £ 10 million fund launched on March 20, 2020 to support research and testing of therapies that could be rapidly deployed to help fight COVID-19.
For more information, please contact:
Carl Johan Dalsgaard, CEO
Telephone: +46 70 975 98 63
E-mail: [email protected]
This information is such that Vicore Pharma Holding AB (publ) is obliged to make it public in accordance with the EU Market Abuse Regulation. The information has been submitted for publication, through the contact persons indicated above on November 2 To 7:45 a.m..
1Phase 2 data from the COVID-19 trial (ATTRACT)
This information was brought to you by Cision http://news.cision.com
The following files are available for download:
SOURCE Vicore Pharma Holding AB