SynAct Pharma AB (“SynAct”) today announced that the single-dose part of the Phase I study with AP1189 has been successfully completed, and that the development program can continue according to plan. Preliminary data showed that AP1189 exhibited a good safety profile and is well tolerated at doses that exceed the expected therapeutic effect by a good margin. AP1189 is being developed as a new potential treatment for, among other things, psoriatic arthritis, a form of joint disorder that affects approximately 30 percent of patients suffering from psoriasis.
SynAct’s CEO, Jeppe Øvlesen, comments:
“We are very excited about the outcome of the initial part of the clinical Phase I study, and look forward to continuing the development of AP1189 as a new oral treatment for psoriatic arthritis and other inflammatory diseases. We are now focusing on the concluding phases of the Phase I study, but preparations are also underway, in parallel, for the first patient study, which is scheduled to start in the first half of 2018.”
AP1189 was administered to a total of 48 healthy subjects in this first part of the ongoing double-blinded Phase I study. The study consisted of eight groups of eight test subjects in each group, six of whom received the active substance and two who received a placebo. Preliminary results show that AP1189 in a single dose has a good safety profile up to doses that produce concentrations in the blood more than 10 times higher than the expected dose levels for therapeutic use. This, together with the good pharmacokinetic profile, supports the continued development of AP1189 for dosing once daily.
The phase I programme continues in the autumn of 2017 with a study in which AP1189 in the form of a newly developed tablet will be given with and without food to investigate how food intake affects the uptake of the candidate drug by the body. Thereafter, AP1189 will be given once daily for two weeks to 36 subjects in a final. multiple dose section. Full analysis and presentation of the data will take place after the entire study has been completed and unblinded.
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 market abuse regulation. The information was submitted by the above contact person for publication on 3 October 2017.