Synact Pharma AB (“Synact”) today announced that the last part of the company’s ongoing phase I program with candidate drug AP1189 has started and that the first group of subjects in the final multiple-dose part commenced dosing with a suspension-aav AP1189.
The purpose of the remaining part of the Phase I study was to study the safety and tolerability and the pharmacokinetic properties of repeated dosing over two weeks. AP1189 will be administered in increasing doses once a day to groups of healthy subjects, of which nine per group receive AP1189 and three receive a placebo in a double-blind, randomised study design. The currently initiated multiple-dose part is carried out with the same suspension formulation* that was successfully used in the previous single-dose part of the study and exhibited a good safety profile and attractive pharmacokinetic properties. The experimental part of the study is expected to be completed before the end of the year and full analysis and presentation of the data will take place after the study is unblinded, i.e. when the treatment code has been withdrawn.
CEO Jeppe Øvlesen comments
“We are very pleased that we have now begun the last part of the phase I programme with AP1189, which gives us a good chance that, given continued positive data, we should be able to initiate a first study in patients with rheumatoid or psoriatic arthritis in the first half of 2019 and thus take the project into clinical phase II development.
* suspension: AP1189 suspended in liquid
For further information about SynAct Pharma AB, please contact:
Jeppe Øvlesen
CEO, SynAct Pharma AB
Telephone: +45 28 44 75 67
E-mail: [email protected]
Thomas Jonassen
CSO, SynAct Pharma AB
Telephone: +45 40 15 66 69
E-mail: [email protected]
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 13th September 2018.