SynAct Pharma AB (“SynAct”) today announced that the candidate drug AP1189 exhibits a continued favourable safety profile and a very promising plasma profile in the second cohort, where healthy subjects have been dosed for 14 days. The third and final 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 of healthy subjects and the pharmacokinetic properties of repeated dosing over two weeks. AP1189 is given in ascending doses that are expected to produce plasma concentrations up to 5 times higher than what is expected to have a therapeutic effect. In the first two cohorts, repeated dosing with AP1189 was safe and well tolerated. Furthermore, a plasma exposure was obtained with an attractive profile, which supports continued clinical development for dosing once daily.
Assuming that the dose level used in the now-ongoing third cohort continues to show that AP1189 is safe and well tolerated, the next step will be to prepare an application to conduct a phase II clinical study on patients with active rheumatoid arthritis. The application is scheduled to be submitted in Q1 2019, with the goal of starting the Phase II study in the spring of 2019.
Preliminary and blinded data show that the pharmacokinetic profile after dosing in the second cohort confirms the attractive pharmacokinetic properties previously seen in the single dose part of the study. The dose used in the second multiple-dose cohort (100 mg) produced a robust exposure with low inter-and intra-variability and the plasma levels of AP1189 in this cohort are considered to be approximately two times higher than required to result in therapeutic effect, i.e. the level at which positive effects in preclinical disease models have been seen.
Full analysis and presentation of data from the entire study will be presented after unblinding, i.e. when the treatment code has been withdrawn. This is expected to take place in the spring of 2019.
CEO Jeppe Øvlesen comments:
“We are very excited about this preliminary data that supports the fact that we have a good safety profile and very attractive plasma exposure to our drug candidate, AP1189, at repeated dosing. We look forward to bringing the project to phase II in the spring of 2019 with the aim of showing Proof of Concept. AP1189 has the potential to become a completely new treatment method in inflammatory and autoimmune diseases, which, unlike most of today’s drugs, does not inhibit the body’s immune system but instead stimulates the immune healing mechanisms.”
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 December 2018.
For further information about SynAct Pharma AB, please contact:
CEO, SynAct Pharma AB
Telephone: +45 28 44 75 67
CSO, SynAct Pharma AB
Telephone: +45 40 15 66 69