SynAct Pharma AB (“SynAct”) today announced that, based on positive data in the recently completed and now unblinded Phase I study, the company, had submitted an application to the Danish Medicines Agency and the Scientific Ethics Committee for permission to conduct a phase IIa study on patients with active rheumatoid arthritis. The study is planned as a randomised, placebo-controlled, double-blind study in which two doses of AP1189 are tested as additions to standard treatment in patients with newly developed active rheumatoid arthritis. The study will be conducted in two parts. The first part will focus on safety and tolerability in patients and will provide an initial indication of effective dose intervals. The second part will focus on studying the effects of AP1189 on the relevant disease parameters. The study will be initiated at clinics in Denmark. Assuming the study is approved in the Second Quarter of 2019, the overall study is expected to be reported at the end of 2020. Interim analysis at the end of the first part of the study is scheduled to be reported during the First Quarter of 2020.
The Phase I study with AP1189, which is now unblinded, focused on studying safety and tolerability as well as the pharmacokinetic properties of AP1189 in healthy individuals. The last part of the study, the multiple dose part, was conducted in three cohorts with twelve subjects (9 active and 3 placebo), with dosing once daily for 14 days. AP1189 was shown to be safe and well tolerated at the doses tested and at the highest dose gave a plasma exposure six times higher than the level expected to be therapeutic. A total of 35 adverse reactions were reported, of which four were assessed to be related to the treatment in the study. The four events, which all related to the digestive tract, were mild to moderate in intensity, were of a short duration and did not give any reason for intervention or break in the study medicine. In the last cohort (200 mg) isolated increases in aminotransferases (marker of liver function) were reported in five subjects. Three of these were reported in subjects treated with active (3 out of 9 with active treatment), two of whom were reported in subjects treated with placebo (2 out of 3 placebo treatment). The largest increase was seen in two people with active treatment. The increases normalised after the completion of the study. There were no observed increases in aminotransferases in the two other cohorts and AP1189 had no effect on vital parameters, including blood counts, heart rate and ECG. Overall, the results support continued clinical development of candidate drug AP1189 for dosing once daily. The planned Phase II study of 90 patients entitled “A double-blind, multi-centre, two-part, randomized, placebo-controlled study of the safety, tolerability, and efficacy of 4 weeks of treatment with AP1189 in early rheumatoid arthritis (RA) patients with active joint disease “, has been submitted to the Danish Medicines Agency and the Ethics Committee for approval to conduct the study in rheumatology departments in Denmark. The study will be conducted with patients with active arthritis who have been referred to the special department for treatment using anti-rheumatic medication that treats diseases for which the initial treatment is methotrexate. In the study the methotrexate treatment is administered as oral treatment in a standard dosing regimen. AP1189 or a placebo will be given in addition to treatment with methotrexate. The primary purpose of the study is to generate a safety profile for the drug in patients and of the drug’s ability to reduce the disease intensity in relation to placebo treatment. The study is scheduled for four weeks of dosing. Assuming the study is approved in the Second Quarter of 2019, the overall study can be reported at the end of 2020. Interim analysis at the end of the first part of the study is scheduled to be reported during the First Quarter of 2020.
CEO Jeppe Øvlesen comments:
“We are very pleased that we are now heading from phase I into clinical phase II and can thus start the Phase II study with 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.”
For further information about SynAct Pharma AB, please contact:
CEO, SynAct Pharma AB
Telephone: +45 28 44 75 67
E-mail: [email protected]
CSO, SynAct Pharma AB
Telephone: +45 40 15 66 69
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 29 March 2019.