SynAct Pharma AB (“SynAct”) announced today, 23rd July 2018, that the Belgian Medicines Agency, the Federal Agency for Medicine and Health Product (FAMHP), and the local Ethics Committee have approved the company’s application to complete the multiple-dose part of the ongoing Phase I study with a suspension formulation of candidate drug AP1189. As previously announced , the experimental tablet formulation used in the first cohort in the multiple-dose of the Phase I study resulted in plasma concentrations varying too much. The company then decided to revert to the previously used suspension formulation of AP1189, which showed more stable pharmacokinetics, for the remaining part of the study.
In the introductory part (single dose) of the ongoing Phase I study, the suspension formulation* of AP1189 had shown good results regarding both safety and tolerability, which exceed the doses expected to produce therapeutic effect by a good margin. The pharmacokinetic properties of AP1189 also provide support for the intention to administer the substance once a day. However, it was found that the experimental tablet formulation used in the first cohort of the multiple-dose part of the study (repeated dosing over 14 days) resulted in excessively variable plasma concentrations. The company then decided to return to the previously used suspension of AP1189, which showed more stable pharmacokinetics and promising plasma concentrations, in the remaining part of the Phase I study. SynAct has now received approval from the relevant regulatory authorities for this change in the study structure.
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 14 days. AP1189 will be given in increasing doses once daily to between three and four groups of healthy subjects, of which nine per group receive AP1189 and three receive a placebo in a double-blind design. Before proceeding to the next dose group, a safety evaluation of the previous group is performed. The study drug is expected to be available in August and the first group of subjects is expected to be dosed during September. Full analysis and presentation of the data will take place after the entire study is complete and unblinded, i.e. when the treatment code has been withdrawn.
CEO Jeppe Øvlesen comments:
“We welcome the swift approval of the Belgian authorities, and now look forward to completing the Phase I study using AP1189. So far, the suspension has proved to work very well, which gives us good opportunities to generate the necessary safety and pharmacokinetic data in order to continue the development programme. Given continued positive data in the Phase I study and successful further development of an appropriate oral formulation, we expect to be able to start a Phase IIa study in patients with rheumatoid and psoriatic arthritis in the first half of 2019
* 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 23rd July 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]