Published on January 2nd, 2017 | by CRST0
CRST Oy & Vicore Pharma have successfully conducted SAD and MAD studies with C21
Clinical Research Services Turku, CRST, has successfully completed two Phase I studies in healthy male volunteers with Vicore Pharma’s novel angiotensin II type 2 (AT2) receptor agonist C21.
All of the objectives of the two Phase I studies were met; C21 was found to be safe and well tolerated in the investigated dose range (up to 100 mg daily), and its pharmacokinetic properties were acceptable for further clinical development. The company can now continue to develop its clinical candidate C21 to a future drug for the treatment of pulmonary fibrosis, an orphan indication that was recently granted to C21 by the European Commission.
“We are very satisfied with the results of the studies. 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 Vicore’s CEO Per Jansson.
“We are happy to assist Vicore Pharma in its clinical development of C21 and we are pleased that the studies have passed uneventfully. We now look forward to the next steps in the development of this exciting new drug with significant potential in the treatment of idiopathic pulmonary fibrosis”, says Professor Mika Scheinin, Chief Scientific Officer of CRST.
“We are really happy about this strong collaboration with Vicore and happy to be part of this very promising and exiting development program”, says Antti Iitiä, CEO of CRST Oy.
The two Phase I studies were carried out between May 2016 and November 2016 and comprised 48 healthy volunteer subjects. Both studies followed standard double-blind, randomized, placebo-controlled ascending-dose designs and aimed to evaluate the safety, tolerability and pharmacokinetics of C21.