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Vicore strengthens rare lung disease pipeline with PAH indication

· Strong preclinical data shows that C21 reverses vascular remodelling · Proof-of-concept trial in pulmonary arterial hypertension (“PAH”) planned to start late 2022 · Appointment of two new senior clinical advisors in PAH

Gothenburg, March 9, 2022 – Vicore Pharma Holding AB (publ) (“Vicore”), a clinical-stage pharmaceutical company developing medicines targeting the Angiotensin II type 2 receptor (AT2R), today announces plans to initiate a clinical trial with C21 in PAH.

Pulmonary arterial hypertension (PAH) is a rare lung disease with huge unmet medical need where existing medicines reduce the pressure by dilating the vessels without changing underlying disease or survival. Both PAH and the pulmonary hypertension associated with idiopathic pulmonary fibrosis come with pulmonary vascular dysfunction contributing to progression of disease and finally cardiac failure.  

Vicore has generated preclinical data in pulmonary hypertension models showing that C21 reverses vascular remodelling and significantly improves hemodynamics. In combination with the vascular effects demonstrated in the mechanistic clinical trial in systemic sclerosis patients, the data supports clinical development in PAH. C21 reduces the pro-fibrotic factor TGFβ in human IPF lung tissue and the established role of TGFβ in the development of PAH further strengthens the hypothesis. If development is successful, C21 would likely enjoy orphan drug status protection in the US and in Europe.

To assist in design and evaluation of the planned trial, the company has appointed two experts in the field as clinical advisors: Professor Chris Denton and Dr Gerry Coghlan. Chris Denton is a professor in experimental rheumatology at UCL Medical School and Joint Director of the Centre for Rheumatology, Royal Free Hospital, London. He runs the largest scleroderma service in the UK with more than 1000 scleroderma patients and has published extensively on laboratory and clinical aspects of Raynaud’s phenomenon, connective tissue disease and pulmonary hypertension. Gerry Coghlan is a cardiologist and leads the national pulmonary hypertension service at Royal Free Hospital. He is a founding member and ex-chair of the National Pulmonary Hypertension Physicians Association and has developed the Royal Free National Pulmonary Hypertension Service, with a particular interest in connective tissue disease associated pulmonary hypertension.

“I am delighted that new drugs with novel mechanisms are moving into clinical trials for PAH that is an important complication of connective tissue disease, including systemic sclerosis”, says Chris Denton, University College London.

We have been investigating PAH as a possible indication for development before, and now with the preclinical data at hand as well as the strong interim data in IPF, we decided to progress C21 to a proof-of-concept trial strengthening our rare lung disease portfolio”, says Carl-Johan Dalsgaard, CEO of Vicore. 

R&D day on March 10, 2022
Vicore Pharma will host an R&D-day in March 10 to further enlighten the market of the recent scientific progress with regards to the receptor localization, experimental evidence in human tissues, progress in the chemistry programs and the new indications that are being evaluated as well as an update on the ongoing clinical trials.  

Register for the event:

About pulmonary arterial hypertension (PAH)
Pulmonary arterial hypertension (PAH) is a progressive disease characterized by high blood pressure in the lung arteries caused by narrowing and obstruction in the arteries of the lung.

C21 – a first-in-class AT2R agonist
C21 is a first-in-class, orally available, low molecular weight, angiotensin II type 2 receptor (AT2R) agonist that activates the “protective arm” of the renin-angiotensin system (RAS) leading to resolution and regeneration following tissue damage. The compound is currently in a phase 2 proof-of-concept trial in IPF and in a pivotal phase 3 trial in COVID-19.

For further information, please contact:
Carl-Johan Dalsgaard, CEO
Phone: +46 70 975 98 63

This information was submitted for publication on March 9, 2022 at 08:00 CET.Vicore strengthens rare disease pipeline with PAH indication

Source: Vicore Pharma