Vicore to announce AIR trial update at the ATS congress on May 21st

Stockholm, March 31, 2023 – Vicore Pharma Holding AB (publ) (“Vicore”), unlocking the potential of a new class of drugs – angiotensin II type 2 receptor agonists (ATRAGs), today announces an oral presentation of updated interim data from the AIR trial during the American Thoracic Society (ATS) International Congress on May 21st in Washington DC.

• Professor Toby Maher will present an update of the phase 2a trial (AIR) in idiopathic pulmonary fibrosis (IPF) during the American Thoracic Society (ATS) international congress
• Results presented will come from a more advanced data set than previously reported, including a thorough analysis of the patient population
• Company selected to be showcased as fibrosis innovator at the ATS respiratory innovation summit

An update of the AIR trial will be presented in the session “Clinical Trials in Chronic Lung Disease” by Professor Toby Maher, Keck School of Medicine at University of Southern California. The ATS congress is an important conference for sharing data and scientific breakthroughs in the field of chronic respiratory disease.

“We are delighted to be able to share our progress in the AIR trial. We have previously communicated a true stabilization over time, and we even see an increase in lung capacity in high responders. With a more advanced data set, it will be of great interest to complete and present further analyses.” says Rohit Batta, CMO of Vicore 

Oral presentation of the abstract; “An updated interim analysis of the AIR trial; an open-label, single-arm, 36-week, phase 2 trial of an angiotensin type 2 receptor agonist, C21, in individuals with IPF” in the session “Clinical Trials in Chronic Lung Disease”.
View abstract: https://www.abstractsonline.com/pp8/#!/10703/presentation/8265
May 21, 2023, 2:15 PM -4:15 PM EST (20:15-22:15 CET)

Hosted by the American Thoracic Society, the 2023 Respiratory Innovation Summit will unite the innovators, investors, clinicians and advocacy groups who are leading the charge to create powerful new treatments for deadly and crippling diseases of the lungs and airways. Vicore has been selected to be showcased at this summit and programmed for an oral presentation.

”We are honored to be selected to be showcased as fibrosis innovator in this prestigious summit. This is a recognition of the quality of the company and the expectations of C21 as new and promising medicine for the treatment of IPF” says Carl-Johan Dalsgaard, CEO of Vicore.

In addition, Vicore will give an oral presentation of the results from the pilot phase of the digital therapeutic study, COMPANION, and present a poster on angiotensin II type 2-receptor agonists (ATRAGs) in rare lung disease: 

Oral presentation of the abstract; “A digital therapeutic for anxiety symptoms in patients with idiopathic pulmonary fibrosis: An open-label pilot clinical investigation”  
View abstract: https://www.abstractsonline.com/pp8/#!/10703/presentation/6394
May 22, 2023, 9:00 AM – 11:00 AM EST (15-17 CET) 

Poster presentation entitled ”Development of angiotensin II type 2 receptor agonists ‘ATRAGs’ for treatment of pulmonary fibrosis and pulmonary hypertension”  
View abstract: https://www.abstractsonline.com/pp8/#!/10703/presentation/8321
May 24, 2023, 8:00 AM – 10:00 AM EST (14-16 CET)

View the scientific program and register for ATS: ATS 2023

About C21 – first-in-class ATRAG (angiotensin II type 2 receptor agonist)

C21 is an innovative, first-in-class, orally available, selective, small molecule ATRAG under development for the treatment of IPF (idiopathic pulmonary fibrosis). C21 has orphan drug designation in IPF both in Europe and the US. The novel and multimodal mechanism of action of C21 targets the underlying fibrosis in IPF by stimulating the protective arm of the renin-angiotensin system (RAS). The AT2 receptor activation triggers protective signaling pathways, promoting alveolar repair and maintenance of alveolar integrity. The fibrosis formation is reduced, disease stabilized and lung capacity increased.

About the phase 2a trial in IPF (AIR)

The main purpose of this therapeutic exploratory trial is to investigate the safety and efficacy of C21 in treatment-naïve patients with IPF. The trial is an open-label, single-arm trial in which C21 is given orally twice daily as monotherapy for 24 weeks with an option to continue treatment for another 12 weeks. Patients with IPF have a well-characterized decline in lung function. The effect of C21 on lung function, measured by change from baseline in Forced Vital Capacity (FVC), is investigated. The trial has multiple centers with regulatory approvals obtained in the UK, India, Ukraine and Russia. The trial is paused in Ukraine and Russia due to the ongoing conflict. In November 2022, Vicore presented an interim analysis of 41 patients, further confirming the previous results with a stabilization of lung capacity already at week 6 and, as also seen in the previous interim analysis, a subsequent increase of lung capacity from weeks 18 to 36. The increase was more pronounced in IPF patients without end-stage destruction of lung parenchyma as documented by high resolution computer tomography (HRCT).

For further information, please contact:

Carl-Johan Dalsgaard, CEO
Phone: +46 70 975 98 63
E-mail: carl-johan.dalsgaard@vicorepharma.com

This information was submitted for publication on March 31 at 08:00 CET.

About Vicore Pharma Holding AB (publ)

Vicore is an innovative Swedish clinical-stage pharmaceutical company dedicated to creating life changing treatments in diseases where the AT2 (angiotensin II type 2) receptor has a central role in stopping and reversing disease pathology. The company is establishing a portfolio in rare lung diseases in cluding idiopathic pulmonary fibrosis (IPF) and pulmonary arterial hypertension (PAH). C21 is a first-in-class orally available small molecule angiotensin II type 2 receptor agonist (ATRAG). Almee™ (an investigational medical device in clinical development) is a digital therapeutic (DTx) based on cognitive behavioral therapy (CBT) created to address the psychological impact of living with pulmonary fibrosis. Inhaled IMID is a new formulation and delivery route of thalidomide targeting the severe cough associated with IPF. With our unique expertise in the ATRAG biology we fuel our pipeline with several new assets with long patent life for a variety of diseases, some of which could be partnered while others can be taken to the market by Vicore itself.

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

Vicore to announce AIR trial update at the ATS congress on May 21st