Positive data from Phase II study ATTRACT in patients with COVID-19 published online
Gothenburg, February 1, 2021 – Vicore Pharma Holding AB (publ), a pharmaceutical company dedicated to developing innovative medicines for severe lung disorders, today published data from the phase II study ATTRACT online and submitted it to a peer reviewed journal. The results show restoration of lung function in COVID-19 on top of corticosteroids and remdesivir with the company’s oral drug C21, suggesting that C21 can become an important complement to vaccines to combat the COVID-19 pandemic.
With close to 100 million registered cases and 2 million deaths to date, there is an urgent need for a safe oral effective therapy to complement the recently launched vaccines. Vicore Pharma’s angiotensin II type 2 receptor (AT2R) agonist C21 showed restoration of respiratory function with a significantly lower risk of being on supplemental oxygen at the end of treatment and during follow up.
The results are now available as a preprint at www.medrxiv.org/content/10.1101/2021.01.26.21250511v1 and have been submitted for publication in a peer reviewed journal.
“The complete analysis confirms the initial observation that C21 is safe, restores lung function and reduces the need for oxygen supplementation in these critically ill COVID-19 patients”, said Carl-Johan Dalsgaard, CEO of Vicore Pharma.
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 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.
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
This information was submitted for publication on February 1, 2021 at 08:00 CET.
About Vicore Pharma Holding AB (publ)
Vicore Pharma 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.
The VP01 project aims to develop the substance C21 for the treatment of idiopathic pulmonary fibrosis (IPF), systemic sclerosis and COVID-19. The VP02 project is based on a new formulation and delivery route of an existing immunomodulatory compound (an “IMiD”). The VP02 project focuses on the underlying disease and the severe cough associated with IPF. Both projects are also being actively evaluated for other indications within the field of interstitial lung diseases which have a significant unmet need. The VP03 project includes follow-up molecules for C21.
The company's shares (VICO) are listed on Nasdaq Stockholm’s main market. For more information, see www.vicorepharma.com.
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