Safe and well tolerated dose of C21 established in successful dose escalation phase 1 study
Gothenburg, September 6, 2019 – Vicore Pharma Holding AB (publ), a pharmaceutical company dedicated to developing innovative medicines for rare lung disorders, announced today that it has completed a 54-subject phase I dose-escalation study in the company’s VP01 project investigating the drug candidate C21, a first in class, oral, angiotensin II type 2 receptor (AT2R) agonist. The study established that 200 mg daily has a good safety profile and that it was the maximum tolerated dose. This dose will be used in the planned phase II studies in idiopathic pulmonary fibrosis (IPF) and diffuse systemic sclerosis (dSSc). Moreover, based on receptor-binding data, Vicore has concluded that this dose results in a free C21 plasma concentration that is sufficient to activate the AT2R. In addition to being a high affinity AT2R agonist, Vicore can now report that C21 is also a low affinity thromboxane receptor (TP receptor) antagonist, which is relevant for conditions such as systemic sclerosis and pulmonary fibrosis where platelet activation contributes to disease manifestations.
“We are pleased that we now have identified a dose that reaches a sufficient free plasma concentration to be able to activate the AT2R target in our upcoming phase II clinical trials in idiopathic pulmonary fibrosis and systemic sclerosis. It is also exciting that we have confirmed a dual action through both the AT2 and the TP receptor. The relative role of the effects of C21 on these two receptors will be further investigated, particularly as both mechanisms are relevant for addressing fibrosis and vasculopathy, giving C21 a unique profile. We are working closely with the clinical and patient communities and look forward to initiating both of our Phase II studies later this year”, says Carl-Johan Dalsgaard, CEO of Vicore Pharma.
For further information, please contact:
Carl-Johan Dalsgaard, CEO tel: +46 (0)70 975 98 63, carl-johan.dalsgaard@vicorepharma.com
This information is information that Vicore Pharma Holding AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication through the agency of the contact person set out above, at 17:30 CET on September 6 2019
About Vicore Pharma Holding AB (publ)
Vicore Pharma is a Swedish rare disease pharmaceutical company focused on interstitial lung diseases and related indications. The company currently has two drug development programs, VP01 and VP02.
VP01 aims to develop the substance C21 for the treatment of idiopathic pulmonary fibrosis (“IPF”) and diffuse systemic sclerosis (“dSSc”). 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 which has a significant high unmet need. The VP01 Phase IIa studies in IPF and dSSc patients are expected to be initiated during the second half of 2019. VP02 is entering a phase of optimization of formulation before local tolerability studies will commence. The first clinical studies with VP02 are expected to start in 2020.
The company's share (VICO) is listed for trading on Nasdaq First North Growth Market in Stockholm. The company´s certified adviser is Erik Penser Bank, telephone: +46 8 463 83 00, e-mail: certifiedadviser@penser.se. For more information, see www.vicorepharma.com