Vicore Pharma restarts mechanistic study with VP01 in systemic sclerosis
After a five months pause due to the Covid-19 pandemic, Vicore Pharma has resumed enrolling patients in the mechanistic study with VP01 (C21) in patients with systemic sclerosis (SSc) and who also suffer from Raynaud’s phenomena (RP). ”We are very excited that the study has started again and if the Covid-19 situation does not change, we expect the study to be completed by year end as planned”, says Anne Katrine Cohrt, Director Clinical Development, Vicore Pharma.
The primary objective of the study is to investigate the efficacy of VP01 on cold-induced vasoconstriction in patients with SSc. It is known that these patients need a longer time to regain blood flow and skin temperature, and a direct relaxing effect on peripheral resistance vessels would shorten that time. Such a potential vascular effect would add further mechanistic understanding of VP01 in addition to the previously demonstrated disease-modifying and beneficial hemodynamic effects observed in the Sugen-hypoxia model.
The study is a randomized, double-blind, placebo-controlled cross-over trial in 16 patients with SSc and accompanying RP. The study will investigate the potential effect on improving blood flow in diseased tissues, an effect that may benefit patients with SSc as well as patients with idiopathic pulmonary fibrosis (IPF).
First in class molecule
VP01, a first in class low molecular weight angiotensin II type 2 receptor (AT2R) agonist, activates the ”protective arm” of the renin angiotensin system (RAS). It is under development for idiopathic pulmonary fibrosis (IPF) and is also being studied in patients with Covid-19.
Vasculopathy in fibrotic disease
Vasculopathy (diseased and dysfunctional blood vessels) is an integral part of fibrotic lung disease, including IPF and fibrotic lung disease as a result of SSc, and contributes to morbidity and mortality.
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