The phase II clinical study with C21 in patients with SSc started to recruit patients in December 2019, and Vicore expects the study to be completed within a year from the start. The study is designed to study the effect of C21 on cold-induced vasoconstriction in patients with SSc. It will shed light on the AT2 receptor’s role in improving blood flow in diseased tissues, an effect that may benefit patients with SSc related pulmonary fibrosis as well as patients with IPF
Vicore have submitted the clinical trial application for a phase II study in IPF. This study will collect information on the safety and efficacy outcomes of VP01 in these patients. The study design has been modified in order to maximize the statistical power to detect a treatment effect, as well as reduce the number of patients needed, hence potentially shortening the time to read-out.
In addition, Vicore has submitted a Letter of Intent (LoI) for a phase II study with C21 in COVID-19. There is a good scientific rationale for studying C21 as a potential treatment of COVID-19. It has recently been shown that the SARS CoV-2 virus utilizes the enzyme ACE2, which is part of RAS, for entry into the cell. This inactivates the ACE2 enzyme, creating an imbalance in the local RAS, leading to acute lung injury. Given that ACE2 generates the natural ligands for AT2R, Vicore Pharma believes that, by acting directly on the AT2R, C21 may suppress inflammatory mediators and bypass the way by which the virus incapacitates the system.
Orphan drug designation
VP01 has been recognized as an orphan drug in IPF by the regulatory authorities in Europe and the USA. This means that it will have market exclusivity for 10 years in the EU after its authorization and 7 years in the USA. The regulatory authorities will also provide us with valuable scientific advice on the design of future clinical trials.