SynAct Pharma AB (“SynAct”) today announced that the clinical Phase I study of candidate drug AP1189 had recently been completed with positive results and that planning is underway for the first Phase II study in patients with active arthritis. To improve the ability to demonstrate the full potential of the drug candidate, the Phase II study will be expanded and divided into two parts. The first part focusses on safety and tolerability in patients and will also provide an initial indication of effective dose intervals.. The second part will focus on studying the effect of AP1189 on the relevant disease parameters. Synact’s available financial resources are sufficient to fund the first part of the Phase II study. The company intends to begin work shortly on identifying an optimal financing solution to cover the additional costs of extending the phase II programme, which is estimated at around SEK 20 million.
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 with 12 patients (9 active and 3 placebo). The study shows that AP1189 is safe and up to 100 mg once daily for 14 days is well tolerated. The levels in plasma achieved with AP1189 at those doses are higher than the estimated level effective for therapeutic efficacy in humans. At the third and highest dose level, a reversible increase in markers of liver effects was noted. Overall, the results support continued clinical development with candidate drug AP1189 for dosing once daily.
The final study result will be determined and reported after the data is unblinded. An application to start a Phase II study of AP1189 is expected to be submitted to the relevant authority at the end of March 2019.
The planned Phase II study with AP1189 will be designed as a randomised, double-blind, placebo-controlled study to study the safety, tolerability and efficacy of treatment with AP1189 in combination with methotrexate in patients with rheumatoid arthritis (RA) with active disease. The study will be conducted as a multicentre study in two parts. The first part, which is scheduled to be conducted in 2019, will focus on safety and tolerability in combination with methotrexate and on identifying an effective dose. The Phase II study will be conducted in Denmark and the first part is estimated to include 36 patients. The second part will be carried out as a direct continuation of the first part, with the primary focus on efficacy evaluation in an additional 54 patients. The results of the complete study are planned to be communicated in the second half of 2020.
Synact’s existing financial resources are sufficient to carry out a limited Phase II study with AP1189, but the company has decided to extend the scope of the study. This is to be able to obtain a more complete dossier of the drug candidate’s potential. The study is planned to cover up to 90 patients. Additional funding of approximately SEK 20 million is required in order to carry out the entire Phase II study and to examine the potential for AP1189 in other indications in detail. The company will initiate work to find a form of financing that is favourable to Synact shareholders. A detailed plan of the further development of AP1189 will be presented in the coming months.
CEO Jeppe Øvlesen comments:
“We are very excited to have identified the dose levels to be used in the forthcoming Phase II study of our First-in-Class candidate, AP1189. At the same time, our work to broaden the development of AP1189 for other indications continues. Not least the fact that, as reported last year, AP1189 has the potential to reduce proteinuria gives us a number of very interesting opportunities.
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 11th February 2019.
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