We are proud of our complementary pipeline. C21 (VP01 program) has been shown preclinically to work through multi-modal pathways, which may benefit complex diseases such as idiopathic pulmonary fibrosis (IPF).
A phase II mechanistic study in SSc patients with Raynauds phenomenon started in December 2019. The study was fully recruited in December 2020 and top line data were published in March 2021. The results showed that C21 dilates peripheral resistance vessels, an effect that is believed to be an advantage in fibrotic lung diseases such as IPF.
In April 2020 we received approval for a phase II study with C21 in COVID 19 patients (ATTRACT) from the UK regulatory agency MHRA shortly followed by approval in India. The first patient was included in India in July and in the end of September the study was fully recruited with 106 patients. Positive top line data was presented in December showing a reduced risk of needing oxygen at the end of the period by 58%, an effect that was statistically significant. There was also a clear trend for C21 reducing the number of patients needing mechanical ventilation with four in the placebo group compared to one in the C21 group. There was also a trend for C21 reducing mortality with three deaths in the placebo group compared with one death in the C21 group. A long-term HRCT scan follow-up of the study, 3-6 months after the last dose of C21, showed a reduction in long-term injury on the lungs of patients with COVID-19.
The positive results from the ATTRACT study led us to continue the development and in September 2021 we dosed the first patients in the pivotal phase III study with C21 in COVID-19 (ATTRACT-3). The study is a randomized, double-blind, placebo-controlled, global, phase 3 trial which will include 600 patients and the primary objective is to evaluate the effect of C21 on recovery from COVID-19. The study is estimated to read-out during the first half of 2022.
During the fourth quarter 2020 we started the recruitment for the phase II study in IPF. The study is performed in UK, India, Ukraine and Russia. We estimate to have the results available by the end of 2022.
VP02 is a new formulation of an existing pharmaceutically active medicine, thalidomide (an IMiD), and is currently in the preclinical stage. We estimate to start a clinical study with VP02 during 2022.
The development of new AT2R agonists in our VP03 program are ongoing with our collaboration partners Emeriti Bio and HaLaCore Pharma and our aim is to have a candidate drug ready by end of 2021 and start phase I studies during the first half of 2022.
Our company’s distinctive approach springs from our collaborative nature and deep roots in world-class science. As one of the potential leaders in the treatment of fibrotic lung diseases, we are committed to bringing these transformational medicines to patients.