Vicore reports data from EndoPAT® exploratory trial
Stockholm, August 22, 2023 – Vicore Pharma Holding AB (STO: VICO) (“Vicore”), unlocking the potential of a new class of drugs – angiotensin II type 2 receptor agonists (ATRAGs), today reports that its clinical study investigating the EndoPAT® technology as a tool to assess the effect of C21 on endothelial function is complete and that the data were inconclusive.
- Purpose was to test the utility of the EndoPAT® technology to study pharmacological vasodilation
- Results were inconclusive due to high intra-individual variability
The study was designed as a single-dose, double-blind, exploratory crossover trial to compare the ATRAG C21 with placebo in eleven patients with type 2 diabetes. However, the intra-individual variability in the EndoPAT® assessments was high, including between placebo and baseline readings in the primary measure, reactive hyperemia index score, resulting in inconclusive data.
EndoPAT® is a diagnostic device that measures endothelium-dependent reflex hyperemia after short-term occlusion of the blood flow to the arm. It is a simple and non-invasive technique that if successful could have facilitated the comparison of efficacy of different ATRAGs and also for assessment of acute effects on endothelial function in various diseases.
Carl-Johan Dalsgaard, CEO of Vicore said: “There is limited experience with EndoPAT in interventional trials and even though we had good hopes for this technology, we have concluded that it is not useful to capture the short-term pharmacological effects we have seen in the human forearm blood-flow study and in systemic sclerosis patients. This finding has no impact on Vicore’s continued work with ATRAGs.”
For further information, please contact:
Carl-Johan Dalsgaard, CEO
Phone: +46 70 975 98 63
Optimum Strategic Communications
Mary Clark, Hana Malik, Zoe Bolt, Katie Flint
Tel: +44 20 3882 2119
This information was submitted for publication on August 22 at 08:00 CET.
About Vicore Pharma Holding AB (publ)
Vicore is an innovative Swedish clinical-stage pharmaceutical company unlocking the potential of a new class of drugs to stop disease progression and restore function. The company is establishing a portfolio in rare lung diseases including idiopathic pulmonary fibrosis (IPF) and pulmonary arterial hypertension (PAH). C21 is a first-in-class orally available small molecule angiotensin II type 2 receptor agonist (ATRAG) currently in a phase 2a study of IPF. C21 is protected by US and European orphan drug designation. A variety of patents have been filed to provide further protection for C21, out to 2040 and onwards. Almee™ (an investigational medical device in clinical development) is a digital therapeutic (DTx) based on cognitive behavioral therapy (CBT) created to address the psychological impact of living with pulmonary fibrosis. Inhaled IMID is a new formulation and delivery route of thalidomide targeting the severe cough associated with IPF. Using its unique expertise in the ATRAG biology Vicore is further fueling its pipeline with several new small molecule drug assets, with long patent life and for a variety of indications, some of which could be partnered while others may be taken to the market by Vicore.
The company’s shares (VICO) are listed on Nasdaq Stockholm’s main market. For more information, see www.vicorepharma.com.