Vicore Pharma receives approval to start Phase IIa study in IPF

2018-04-18 | Regulatory

Vicore Pharma Holding (publ) (ticker: VICO) today announces the approval from the British Medicines Agency MHRA and the Ethics Committee for London and Surrey to conduct a Phase IIa study on IPF

“We are very pleased with this important approval and we are looking forward to starting the study together with our clinical research partners at different hospitals and with PAREXEL. This approval marks one of the biggest milestones so far in the company’s development.” says Per Jansson, CEO

The Phase IIa study is a double-blind and placebo-controlled study that will include 15+15 patients, where 15 patients will receive a daily dose of 100 mg C21 and 15 patients will receive placebo for one month. The objective of the study is to evaluate the effect on IPF (measured as biomarkers) and the safety of C21 in this patient category. Dr Joanne Porter at the University College of London (UCL) is the principle investigator for the study.

IPF is a very serious lung disease. The disease is progressive and the five-year survival is about 30% of affected patients. There are currently two approved drugs which have proven to slow down the decline of the lungs on the market. The drugs are associated with troublesome side effects and have not yet shown that they can improve survival or quality of life for the affected patients. About 60-70% of IPF patients choose to discontinue treatment due to side effects associated with the drugs or decline treatment on the whole. There is thus a significant need for new drugs with better side effect profiles and which can prolong survival and improve quality of life for affected patients.

C21 has demonstrated to prevent fibrosis as well as to reverse fibrosis in preclinical studies in various fibrotic models. The unique multimodal effect of C21 can therefore play an important role in treating patients with fibrotic diseases such as IPF. 

For more information, please contact:

Per Jansson, CEO
M: +46 709 174 746 or 

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 11.15 CET on April 18, 2018

About Idiopatic pulmonary fibrosis (IPF)
This disease affects the small alveoli and the lung tissue adjacent to the alveoli which are are both subject to fibrotization and loss of function. The aetiology of the disease is unknown but it is believed to be an excaggerated healing response to a minor insult and the end-result is general thickening and damage to the lung structure causing oxygen absorbtion impairment. The disease usually occurs at ages between 50-70 and the prevalence is approximately 14-42 cases per 100 000 inhabitants. The disease is progressive and five-year survival is around 30 percent