Phase I-study succesfully completed
Vicore Pharma has completed the two-part Phase I study in healthy male volunteers and have thereby passed an important milestone in the company's development.
Vicore Pharma has completed the two-part Phase I study in healthy male volunteers and have thereby passed an important milestone in the company's development. The results show that all the objectives in the two Phase I studies have been met; C21 is well tolerated, safe in high doses and exhibits consistent blood levels. The company can now continue the development of the C21 to a future drug for the treatment of pulmonary fibrosis.
We are very satisfied with the results of the study. The outcome is exactly what we expected and hoped for. We have information on the absorption of C21 in humans and we know that it has been well tolerated even at repeated and increasing dosages. C21 is thus considered to be a platform for clinical development, primarily for pulmonary fibrosis, but hopefully also for other rare diseases where we have strong animal data. The company is now intensifying discussions with potential partners for the next stage of development says CEO Per Jansson.
The Phase I -study was carried out between May 2016 and November 2016 at the Clinical Research Services Turku (CRST) in Finland, and comprised 48 healthy subjects. The study was a double-blind, randomized, placebo-controlled study of orally administered C21 in increasing doses. The purpose of this study was to evaluate the safety, tolerability and pharmacokinetics.
For further information, please contact:
Lena Lindblad, Operations Manager
T: 070-603 46 25 or e-mail: email@example.com;
Per Jansson, CEO