SynAct Pharma AB (“SynAct”) today announced that the company has received all the regulatory approvals necessary to start the first clinical study with the candidate drug AP1189. The study will be conducted in Belgium. it will begin at the end of May, with the first dosing calculated to take place in early June 2017. AP1189 is being developed as a new potential treatment for psoriatic arthritis, a form of joint disorder that affects approximately 30 percent of patients suffering from psoriasis.
SynAct submitted the application to initiate a clinical Phase I study to the Belgian authorities in April 2017 and has now received approval from both the Belgian Medicines Agency and the Ethics Committee. The primary purpose of the study is to evaluate the safety and tolerability of AP1189 in healthy subjects and to study the pharmacokinetics of the substance, i.e. How it is absorbed and metabolized (broken down) by the body. In the first part of the study, AP1189, which is taken orally, will be given in single ascending doses. In a second part of the study, AP1189 will be given in ascending daily doses for up to 14 days. Furthermore, food interaction will be studied, i.e. how food may affect the uptake of AP1189 by the body.
The study is scheduled to begin at the end of May, with the first dosing calculated to take place in early June 2017. In total, up to 108 healthy test subjects will be studied. Results from the study are expected to become available in the First Quarter of 2018.
CEO Jeppe Øvlesen comments
“We are very pleased to have received this long-awaited announcement and that we are able to initiate the first clinical study of SynAct’s candidate drug AP1189. The results of the Phase I study will provide both the company and potential commercial partners with valuable information for the further development of AP1189, a new potentially promising treatment for the significant proportion of psoriatic patients affected by severe joint symptoms, where there is still a great need for new safe and effective treatment options.
For further information about SynAct Pharma AB, please contact:
Jeppe Øvlesen Thomas Jonassen
CEO, SynAct Pharma AB CSO, SynAct Pharma AB
Telephone: +45 28 44 75 67 Telephone: +45 40 15 66 69
E-mail: [email protected] E-mail: tj@synactpharma.com
This is information that SynAct Pharma AB is obliged to disclose under the EU’s market abuse regulation. The information was submitted by the above contact person for publication on 10 May 2017.