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Vicore’s C21 reduces long-term lung injury after COVID-19 in the ATTRACT Phase 2 extension study

· The results showed nearly 50% reduction in lung injury in the C21 group compared with the placebo group · These positive findings together with previous clinical results[1 ]suggest that C21 could accelerate recovery · C21 is currently being evaluated in a phase 3 trial in COVID-19 patients

Gothenburg, November 2, 2021 – Vicore Pharma Holding AB (publ) (“Vicore”), a rare disease pharmaceutical company developing innovative medicines for severe lung disorders today announces results that treatment with the company’s AT2R agonist C21 reduces long-term lung injury in hospitalized COVID-19 patients.

The new results are based on high-resolution computerized tomography (HRCT) scans from a 3–6-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 C21-treated patients (n=17) displayed reduced pathological abnormalities compared to the placebo-treated group (n=16); in the C21 group, on average 10.3% of the lung was affected compared to 19.2% in the placebo group. The dominating radiological change was ground glass opacity, a pathological characteristic following viral respiratory infection. Although functional tests were not performed in this study, it is known that reduced gas exchange is a common lung function abnormality in COVID-19 patients with an abnormal HRCT at three months.

These promising results are encouraging news for patients and physicians involved in Vicore’s ongoing phase 3 ATTRACT-34 trial in COVID-19 and suggests that C21 have the potential to accelerate recovery after COVID-19. It also indicates that the lasting injury that some patients experience after severe COVID-19 may be improved by treatment with C21. said Elin Rosendahl, VP clinical development of Vicore Pharma.

Lung injury scores were assessed by an independent blinded radiologist experienced in HRCT scan reading at a national center for thoracic disease in the UK. Scores were cumulative totals of conventional lung injury types commonly assessed by radiologists. Follow-up HRCT scans were recorded as part of local clinical practice at follow-up visits performed 90-170 days after the 7-day treatment period in the ATTRACT trial in patients who had received either C21 or placebo on top of standard-of-care including steroids and the antiviral remdesivir. To our knowledge, this is the first time effects of pharmaceutical intervention on long-term lung injury after COVID-19 is 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 via this link. The randomized, double-blind, placebo-controlled trial showed that C21 on top of standard of care significantly reduced the proportion of COVID-19 patients requiring supplemental oxygen, indicating faster patient recovery compared to placebo.

ATTRACT-3, ongoing phase 3-trial in COVID-19
The pivotal phase 3 ATTRACT-3 trial design was approved by the FDA in June 2021 and is currently recruiting patients in US, Czech Republic, Ukraine, India, South Africa, and Philippines. ATTRACT-3 is a randomized, double-blind, placebo-controlled, global, phase 3 trial which will include 600 adult patients hospitalized with COVID-19 requiring oxygen support but not mechanical ventilation. This is a patient category that is different from those being addressed by antivirals. The primary objective is to evaluate the effect of C21 on recovery from COVID-19. ATTRACT-3 is 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 IPF5, 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 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

This information is such that Vicore Pharma Holding AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons set out above on November 2 at 07:45 CET.

1. Phase 2 data from COVID-19 trial (ATTRACT)
2. NCT04878913
3. NCT04452435
4. NCT04880642
5. NCT04533022

Source: Vicore Pharma