Update on progress in clinical lead program VP01 (C21)
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, firstname.lastname@example.org