CSO Thomas Jonassen says
“The Covid-19 lockdown had major impact on the possibility to recruit patients to clinical trials, but we were fortunate to have the possibility to get some progress in the study during Covid-19 lockdown, not at least thanks to our very dedicated investigators. These factors have enabled us to maintain positive momentum in clinical development. We are now dosing with good progress at the 100 mg dose level. We expect to have all sites in Denmark, Sweden and Norway to actively recruit after the summer break, which means that we expect to get recruitment to part 1 of the study completed within the next 2 months.”
The study is designed as a placebo-controlled double-blind multicenter study with a 2:1 randomization of active vs placebo (ie two patients is treated with AP1189 for each patient treated with placebo) in patients referred to rheumatological departments due to uncontrolled disease activity defined as clinical disease activity index (CDAI) higher than 22. The patients are dosed with AP1189 or Placebo and in parallel treatment with the disease modulating anti-rheumatic drug, methotrexate will be initiated. AP1189 or placebo is given once daily for 4 weeks. When dosing in this second cohort of the part 1 of the study is completed, the study will continue into part 2 of the study where it already, based on data from a blinded review has been decided to continue with the 50 mg dose. If the 100 mg dose level is found safe and well-tolerated this dose level will continue in part 2 as well.
SynAct expects that the cash on hand and the additional funds from the exercise of the warrants of series TO 2 in July 2020, will be sufficient to secure the continued clinical development of the AP1189-compound in the scheduled Phase II studies in RA, and in idiopathic membranous nephropathy, NS where the study was initiated in June 2020.