We are proud of our complementary pipeline. VP01 has been shown preclinically to work through multi-modal pathways, which may benefit complex diseases such as idiopathic pulmonary fibrosis (IPF) and systemic sclerosis related pulmonary fibrosis (SSc).
A phase II study in SSc patients with Raynauds phenomenon started in December 2019. It had a fast initial recruitment but was paused in March due to the situation with Covid-19. The study was fully recruited in December 2020 and we are expecting top line data in February 2021.
In April we received approval for a phase II study with VP01 in COVID 19 patients 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 40%, 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.
In May, we received approval from MHRA to start a phase II study in IPF. Patient recruitment started during the fourth quarter 2020.
VP02 is a new formulation of an existing pharmaceutically active medicine and is currently in the preclinical stage. We estimate to enter clinical development with VP02 in 2021.
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.