(MENAFN- PR Newswire)
- The AIR trial is a single arm, multicenter phase 2 study in patients with idiopathic pulmonary fibrosis (IPF)
- Interim data have shown stabilization of the disease and an increase in lung capacity at 24 and 36 weeks
- Oral presentation by Professor Toby Maher on September 4 at 15:00 CET
GOTHENBURG, Sweden, Aug. 17, 2022 /PRNewswire/ -- Vicore Pharma Holding AB (publ) ('Vicore'), a clinical-stage pharmaceutical company developing medicines targeting the angiotensin II type 2 receptor (AT2R), today announces that the previously published interim data from AIR, a phase 2 trial in IPF), will be presented as an oral 'late-breaker' on September 4 at 15:00 CET during the European Respiratory Society (ERS) congress in Barcelona, Spain.
The AIR trial1 is an open label single arm phase 2 trial in treatment naïve IPF patients in which 100 mg of C21 was administered twice daily for 24 weeks with an optional 12-week extension. The trial is being conducted in the UK, India, Ukraine and Russia. The IPF diagnosis was established through central reading of high-resolution computer tomography (HRCT). To assess lung function, the gold standard for FVC* measurements was used at all sites. Earlier this year, the company reported promising interim data with increases in lung capacity after 24 to 36 weeks treatment with C21.
The interim data showed that at 24 weeks, the mean FVC was +251 ml (n=9) over baseline versus the expected -120 ml reduction in an untreated population (a difference of 370 ml). At 36 weeks, 5 out of the 7 patients further increased their lung capacity, and 2 remained stable. C21 was safe and well tolerated. The phase 2 trial continues to enroll patients, and in parallel, the company is preparing for the next trial in close collaboration with regulatory and scientific experts.
'The magnitude of the impact on FVC seen in this interim analysis is truly interesting with an increase in lung function over time and if it holds through in a controlled trial, C21 will create a paradigm shift in IPF.' says presenter Professor Toby Maher, the Keck School of Medicine at the University of Southern California
Presentation details ERS Session: What is hot in interstitial lung diseasesTitle: Late Breaking Abstract - Interim results from AIR, an open-label, single arm, 36-week ph 2 trial of C21 in subjects with idiopathic pulmonary fibrosisPresenter: Professor Toby MaherReference: OA1397Date and time: Sunday, September 4 at 15:00 CETLink:
About Idiopathic Pulmonary Fibrosis (IPF)
IPF is a debilitating lung disease with a prognosis worse than most cancers. Today, there are two approved treatments for IPF, Ofev® (nintedanib), registered trademark of Boehringer Ingelheim, and Esbriet® (pirfenidone), registered trademark of Roche, which reduce the rate of progression by 50 percent, but with significant side effects and reduced quality of life.
About angiotensin II type 2 receptor agonists (ATRAGs)
The AT2R is part of the body's regeneration and repair system and is suggested to be involved in several diseases connected to ageing and cell senescence, including idiopathic pulmonary fibrosis, chronic kidney disease, heart failure as well as cognitive disorders. Stimulating AT2R has been shown to be effective in combatting disease in numerous models and clinical validation is well advanced in acute and chronic lung disease. Stimulating AT2R also dilates small diseased resistance vessels in animals and in humans, resulting in locally increased blood flow.
For further information, please contact: Carl-Johan Dalsgaard, CEOPhone: +46 70 975 98 63 E-mail: [email protected]
This information was submitted for publication on August 17, 2022 at 08:00 CET.
[1] NCT04533022
*Forced Vital Capacity, a measure of lung capacity
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| | Vicore IPF interim data selected as an oral late breaker at the ERS congress |
SOURCE Vicore Pharma Holding AB
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