Vicore Pharma restarts mechanistic study with VP01 in systemic sclerosis

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Gothenburg, August 25, 2020 – Vicore Pharma Holding (publ), a pharmaceutical company dedicated to developing innovative medicines for rare lung disorders, today announces that patients are again being enrolled in the systemic sclerosis study after the pause due to the Covid-19 pandemic.

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.

Study design

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.

For further information, please contact:

Carl-Johan Dalsgaard, CEO, tel: +46 70 975 98 63, carl-johan.dalsgaard@vicorepharma.com  

About Vicore Pharma Holding AB (publ)
VVicore Pharma is a rare disease pharmaceutical company focused on rare lung disorders and related indications. The company currently has three drug development programs, VP01, VP02 and VP03.

VP01 (C21) is being developed for the treatment of idiopathic pulmonary fibrosis (“IPF”), pulmonary fibrosis in systemic sclerosis (“SSc”) and COVID-19. VP02 is based on a new formulation and delivery route of an existing immunomodulatory compound (an “IMiD”). VP02 focuses on the underlying disease and the severe cough associated with IPF. VP01 and VP02 are also being actively evaluated for other indications within the field of interstitial lung diseases where there are significant unmet needs. VP03 includes follow-up molecules for VP01.

The company's shares (VICO) are listed on Nasdaq Stockholm’s main market. For more information, see www.vicorepharma.com.