SynAct Pharma AB (“SynAct”) today announced that candidate drug AP1189 exhibited a promising plasma profile in the first cohort of healthy subjects after 14 days of repeated dosing. The second cohort of the ongoing Phase I study has recently begun.
The purpose of the ongoing Phase I study was to study the safety and tolerability and the pharmacokinetic properties of repeated dosing over two weeks. AP1189 is 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. Dosing is given with the same suspension formulation* which was successfully used in the previous single dose part of the study, which then exhibited a good safety profile and attractive pharmacokinetic properties. Dosing in the first cohort of the multiple-dose part was completed in September 2018 and dosing in the next cohort was initiated in October 2018 after the first dose was deemed to be safe and well-tolerated.
Preliminary and blinded data show that the pharmacokinetic profile after dosing in the first cohort confirms the attractive pharmacokinetic properties previously observed after single doses in the first part of the Phase I study. The dose used in the first multiple-dose cohort (50 mg) produced very robust exposure with low inter-and intravariability and plasma levels of AP1189 are deemed to be high enough to result in a therapeutic effect.
Based on this data, the clinical part of the Phase I study is expected to be completed at the end of 2018. Full analysis and presentation of the data will be carried out after unblinding, that is, when the treatment code has been withdrawn.
CEO Jeppe Øvlesen comments:
“We are very excited about the preliminary data showing that we have a very attractive plasma profile for our drug candidate AP1189 at repeated dosing. It is very promising that we had already reached a level of exposure that is expected to give therapeutic effect after dosing in the first cohort. This, in combination with the good safety profile, gives us the opportunity to get a good safety margin for the candidate drug when we enter the Phase II study next year.”
* suspension: AP1189 suspended in liquid.
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 22nd October 2018.
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]