Positive results show that C21 can become an important complement to COVID-19 vaccines

Gothenburg, December 21, 2020 – Vicore Pharma Holding AB (publ), a pharmaceutical company dedicated to developing innovative medicines for severe lung disorders, today reports an expanded data analysis to follow up the encouraging top line data from the ATTRACT study reported on December 8, 2020. The data show restoration of lung function in COVID-19 with the company’s oral lead candidate drug C21, suggesting that C21 can become an important complement to vaccines to combat the COVID-19 pandemic. A webcast presentation will be held today at 15:00 CET (9:00 am EST).

With COVID-19 increasing world-wide, with more than 600,000 new cases and 10,000 deaths registered per day, there is an urgent need for a safe oral effective therapy as an important complement to the recently launched vaccine efforts.

“The critical incident in COVID-19 that makes this disease different to a common cold is the progression to the distal airways with respiratory distress and subsequent need for oxygen supplementation”, said Carl-Johan Dalsgaard, CEO of Vicore Pharma. “Our data clearly show that C21 can restore lung function on top of steroids and normalize gas exchange. A safe oral medication with such properties can become an important complement to vaccines to combat the pandemic”.

Updated summary of results

• C21 gradually lowered the risk for patients needing oxygen supplementation with reductions of 40% (p=0.057) at the end of the 7-day treatment and 57% (p=0.014) at day 8 after start of treatment.
• At the end of the trial, about a week after the last dose of C21, the effect was even more pronounced, with only one patient in the C21 group still needing oxygen supplementation compared to 11 patients in the placebo group - a reduction by >90% (p<0.002). 
• In the subgroup of patients needing oxygen supplementation (about 30 patients per treatment group), C21 produced a greater reduction of CRP (C-reactive protein) than in the placebo group, an effect that was statistically significant at the predefined 10% level.
• As reported on December 8, there was a clear trend for C21 reducing the number of patients needing mechanical ventilation and a trend for C21 reducing mortality. The data also showed that the treatment was safe and well tolerated.

The reduced need for oxygen supplementation indicates that C21 stops virus-induced pathological processes in the distal airways and thereby restores lung function. The improvement developed gradually and became more pronounced after the treatment period, and the results suggest that C21 may also be capable of preventing respiratory damage caused by the virus, and in doing so the development of COVID-19. 

Webcast presentation           
Vicore Pharma will host a webcast to present more about the outcome of the study at 15.00 CET (9:00 am EST) today that can be accessed via the link: https://financialhearings.com/event/13570

The presentation will be available before the webcast at:
https://vicorepharma.com/investors/events-presentations/

Study design     
In the ATTRACT study (Angiotensin II Type Two Receptor Agonist COVID-19 Trial), a randomized, double-blind and placebo-controlled trial, a total of 106 hospitalized patients with a diagnosis of coronavirus SARS-CoV-2 infection (confirmed by polymerase chain reaction test) and signs of an acute respiratory infection but not requiring mechanical ventilation were recruited. The patients were randomized to receive oral treatment with C21 (100 mg b.i.d., n=51) or placebo (n=56) for seven days on top of standard of care (physician’s choice) with a follow up after 7-10 days.  According to data analyzed to date, the treatment groups were well balanced regarding age, sex and concomitant medications.  Importantly, the vast majority of patients received corticosteroid treatment.

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 IPF lung slices, and a phase II proof-of-concept study in IPF has recently started. Given that AT2R agonism has therapeutic potential in a number of additional indications with significant unmet needs, Vicore Pharma has intensified the efforts to develop proprietary follow-up molecules with different profiles.

LifeArc funding                         
The ATTRACT study received £1.5 million in funding from the UK charity LifeArc - Coronavirus (COVID-19) Therapeutics - https://www.lifearc.org/funding/COVID-19-funding-2/ - 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.

Ends

For further information, please contact:

Vicore Pharma Holding AB
Carl-Johan Dalsgaard, CEO
Tel: +46 70 975 98 63
E: carl-johan.dalsgaard@vicorepharma.com  

Optimum Strategic Communications
Mary Clark, Eva Haas, Shabnam Bashir
Tel: +44 (0) 20 8148 3040
E: vicore@optimumcomms.com

This information was submitted for publication on December 21, 2020, at 08:00 CET

About Vicore Pharma Holding AB (publ)
Vicore is a rare disease pharmaceutical company focused on rare lung disorders and related indications. The company currently has three drug development programs, VP01, VP02 and VP03. VP01 aims to develop the substance C21 for the treatment of idiopathic pulmonary fibrosis (“IPF”), pulmonary fibrosis in systemic sclerosis (“SSc”) and COVID-19. VP02 is based on a new formulation and delivery route of an existing immunomodulatory compound (an “IMiD”). VP02 focuses on the underlying disease and the severe cough associated with IPF. VP01 and VP02 are also being actively evaluated for other indications within the field of interstitial lung diseases which have a significant unmet need. VP03 includes follow-up molecules to VP01.

The company's shares (VICO) are listed on Nasdaq Stockholm’s main market. For more information, see www.vicorepharma.com.