Vicore Pharma announces completion of patient enrollment in the COVID-19 ATTRACT trial
Gothenburg, October 1, 2020 – Vicore Pharma Holding AB (publ), a pharmaceutical company dedicated to developing innovative medicines for rare lung disorders, today announces that the last patient has been randomized in the ATTRACT COVID-19 VP01 trial.
The last patient in the ATTRACT (Angiotensin II Type Two Receptor Agonist Covid-19 Trial) study has now been randomized and will be treated for up to one week and then followed up for another week. Thereafter, the data is quality controlled and the database will be locked before the study is unblinded for analysis. Top-line results are expected to be available before year end as previously announced.
“It is an exceptional performance by the team and our CRO. After facing recruitment challenges in the UK, the study was moved to another country and then fully recruited in about two months’ time” says Carl-Johan Dalsgaard, CEO of Vicore Pharma.
Dr Catriona Crombie, Associate Director, Technology Transfer at LifeArc said “LifeArc’s mission as a charity is to advance early science into patient benefits. We were very pleased to be able to support trials for repurposed therapeutics for patients through our COVID-19 research fund, and it’s rewarding to see the progress made in achieving this significant trial recruitment milestone. We look forward to receiving the first set of data.”
Study design
ATTRACT is a randomized, double-blind, placebo-controlled trial in 106 hospitalized COVID-19 patients with an intense inflammatory drive in the lungs which can develop into acute respiratory failure if it progresses. The patients, who are not on mechanical ventilation at randomization, receive oral treatment with 100 mg of VP01 (C21) or placebo twice daily for seven days. The primary objective with the study is to investigate efficacy of VP01 on inflammation, ventilation and other functional parameters.
The ATTRACT study received £ 1.5 million in funding from the UK charity LifeArc. Read more about its research fund to address the challenges of COVID-19; https://www.lifearc.org/news/2020/lifearc-launches-10-million-research-fund-to-address-the-challenges-of-covid-19/
VP01, a first in class AT2R agonist
VP01 (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). It is under development for idiopathic pulmonary fibrosis (and is also being studied in Raynaud’s phenomenon in patients with systemic sclerosis. Internal preclinical findings with VP01 suggested that it may also be useful in the treatment of COVID-19.
VP01 could bypass negative effects of COVID-19
The RAS is understood to play an important role in the development of COVID-19 because angiotensin II (Ang II) is upregulated and contributes to the inflammatory reaction in the lungs. Moreover, the protective arm of the RAS is disarmed by SARS-CoV-2 which binds to the enzyme angiotensin converting enzyme 2 (ACE2) and thereby inhibits the conversion of Ang II to endogenous protective molecules stimulating the AT2R. Because VP01 directly stimulates the AT2R, it may bypass the negative effects of viruses like SARS-CoV-2 on the protective RAS functions.
For further information, please contact:
Carl-Johan Dalsgaard, CEO, tel: +46 70 975 98 63, carl-johan.dalsgaard@vicorepharma.com
This information was submitted for publication on October 1, 2020, at 08:00 CET
About LifeArc
LifeArc is a UK-based self-funded medical research charity. Their mission is to advance translation of early science into health care treatments or diagnostics that can be taken through to full development and made available to patients.
LifeArc has made £ 10 million available for clinical COVID-19 research to repurpose existing medicines or those in the late stage of development as this approach offers one of the fastest routes to develop new treatments that could tackle the virus and its impact.
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.
VP01 aims to develop the substance C21 for the treatment of idiopathic pulmonary fibrosis (IPF), systemic sclerosis 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 for VP01.
The company's shares (VICO) are listed on Nasdaq Stockholm’s main market. For more information, see www.vicorepharma.com.