SynAct Pharma AB (“SynAct”) today announced that dosing with candidate drug AP1189 in the third and final cohort of the ongoing multiple-dose part of the Phase I study is completed. SynAct now awaits unblinded data to determine the final result in the Phase I study. In parallel, work is underway to compile the government application for the first patient study with AP1189.
The purpose of the Phase I study was to study the safety and tolerability of AP1189 in healthy subjects and the pharmacokinetic properties of repeated dosing over two weeks. The multiple-dose part was conducted in three cohorts of 12 subjects, with 9 given AP1189 and 3 given placebo treatment. Based on data from the first two cohorts, the formulation used shows an attractive plasma profile that supports continued clinical development with candidate drug AP1189 for dosing once daily.
The pharmacokinetic results are expected to become available after year-end 2019 and the study is planned to be unblinded during February 2019. In parallel with this work, SynAct will continue the planning of a double-blind, randomised Phase II study to evaluate the safety, tolerability and therapeutic efficacy of AP1189 in combination with methotrexate in patients with active rheumatoid arthritis (RA ).
When pharmacokinetic data from the last cohort is available, SynAct will be able to define the final formulation of the Phase II study, including the appropriate dose levels and number of patients. An update on this is planned to be communicated during Quarter 1 of 2019.
CEO Jeppe Øvlesen comments:
“We are glad that the dosage in the Phase I study with our drug candidate AP1189 is now completed according to plan. We are now awaiting the final study results and look forward to being able to complete the planning of the first patient study with AP1189 in the spring of 2019, with the goal of being able to show Proof-of-Concept for our drug candidate. AP1189 has the potential to become a 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 21st 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