Vicore Pharma expands VP01 (C21) clinical program to enable functional read out
An expansion of the planned clinical phase IIa study in IPF patients – in number of patients, dose and also in treatment duration – is the result of a longer preclinical safety study that has recently been completed. This creates a number of important benefits in relation to the next development phase of C21, including the possibility of showing an efficacy signal in lung function, as measured by forced vital capacity (FVC), which will be an important endpoint for the future registration of C21.
“C21 is a very interesting compound that has the potential to be an effective treatment of IPF, which is a fatal disease with a high unmet medical need. But in order to succeed, we must ensure the clinical program is designed to provide the highest probability of success”, said Vicore Pharma’s CEO, Dr. Carl-Johan Dalsgaard.
“We have therefore taken the decision to redesign the Phase IIa study that was announced earlier this year to also include a more functional read out, including both efficacy and safety. The new design follows after a strategic review taking into account the results from the longer pre-clinical safety study.”
These data also give Vicore Pharma the opportunity to increase the exposure, and it will therefore help to identify new higher doses of C21 in man before selecting the most optimal dose regimen for the IPF study. The company expects to initiate the expanded program in January 2019 and the clinical phase IIa study in IPF patients is expected to start six months later.
For further information, please contact:
Dr. Carl-Johan Dalsgaard, CEO: +46 709 759 863, 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 08:00 CET on September 10, 2018.