Update on progress in clinical lead program VP01 (C21)
Gothenburg, October 1, 2019 – Following the successful dose escalation phase I study, Vicore Pharma Holding AB (publ), a pharmaceutical company dedicated to developing innovative medicines for rare lung disorders, today announces an update with regards to its clinical lead program VP01 (C21) and confirms progress according to plan.
A phase II CTA (clinical trial application) has been filed with the MHRA, the regulatory body in the UK, for studying the effect of a single dose of C21 on cold induced vasoconstriction in subjects with systemic sclerosis (SSc). “This study will enable us to document a potential direct vasodilatory effect of C21 in man which may benefit patients with SSc, as well as patients with idiopathic pulmonary fibrosis (IPF)” says Carl-Johan Dalsgaard, CEO of Vicore.
Furthermore, the pharmaceutical formulation development together with Ardena in Gent has progressed ahead of schedule allowing Vicore to switch from an oral solution to capsules in the upcoming phase II proof of concept study in IPF. “This is a significant advancement” Carl-Johan Dalsgaard continues, “since a capsule formulation is much more nimble for the patient, superior from a logistical point of view and could be used in the commercial setting if the product reaches the market. The application for the IPF study with the new formulation is expected to be filed later this year, in line with our previous communication.”
For additional information about Vicore Pharma, see our Company presentation.
For further information, please contact:
Carl-Johan Dalsgaard, CEO, tel: +46 (0)70 975 98 63, carl-johan.dalsgaard@vicorepharma.com
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 shares (VICO) are listed on Nasdaq Stockholm’s main market. For more information, see www.vicorepharma.com.
Tags: