Phase II study in Idiopathic Pulmonary Fibrosis (AIR)
The main purpose of this therapeutic exploratory study is to investigate the safety and efficacy of C21 in treatment-naïve patients with IPF and to provide a clear go/no go for confirmatory phase.
The AIR study was designed in collaboration with international clinical experts in IPF and is focused on the patient’s needs and preferences, e.g., all patients receive active treatment. It is an open-label, single-arm study 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. Effect of C21 on lung function, measured by change from baseline in forced vital capacity (FVC), will be investigated and interpreted in the light of the well-documented natural history of IPF.
The study has multiple centers with regulatory approvals obtained in the UK, India, Ukraine and Russia. The first patient was recruited in November 2020 and the study is estimated to read-out in Q4, 2022.
Phase II study in IPF (AIR)
Phase III study in COVID-19 (ATTRACT-3)
The main purpose of ATTRACT-3 in which C21 is tested for the treatment of COVID-19 with the objective of generating key efficacy and safety data for assessment by regulatory bodies, including the US FDA. The study is ongoing and the first patients where dosed in September.
ATTRACT-3 is a randomized, double-blind, placebo-controlled, multinational, phase 3 trial which will include 600 adult patients hospitalized with COVID-19 requiring oxygen support but not mechanical ventilation. The primary objective is to evaluate the effect of C21 on recovery from COVID-19.
For more information about the study; ATTRACT-3 on Clinicaltrials.gov
Phase II study in COVID-19 (ATTRACT) and long-term follow-up (ATTRACT-2)
The main purpose of this therapeutic exploratory study was to investigate if C21, through stimulation of AT2R, could improve the clinical outcome in patients hospitalized with COVID-19. The study included adult patients with confirmed SARS-CoV-2 infection and signs of acute respiratory infection, but not requiring invasive or non-invasive mechanical ventilation.
ATTRACT was a randomized, double-blind, placebo-controlled, parallel-group, multicenter study performed on top of standard-of-care. C21 was given orally, twice daily for 7 days and the patients were followed for 14 days. The study was initiated in July 2020 and completed in September 2020. The results were publicly shared in December 2020.
For more information about the background and the results from the ATTRACT study
Phase II study in COVID-19 (ATTRACT)
Phase II mechanistic study in systemic sclerosis
The main purpose of this mechanistic study was to examine the role of the AT2R in acute improvement of blood flow in fibrotic tissues and thus demonstrate proof-of-mechanism with regards to the proposed vasodilatory effects of C21. This effect may benefit patients with SSc-related pulmonary fibrosis as well as patients with other interstitial lung diseases such as IPF.
This was as a randomized, double-blind, placebo-controlled, single-dose study utilizing a cross-over design to control for inter-individual variability in response to cold challenge. The study was initiated in December 2019 and completed in December 2020. The results were publicly shared in March 2021.
For more information about the background and the results from the SSc study
Phase II mechanistic study in SSc