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SynAct Pharma AB ("SynAct") today announces that recruitment to the second cohort in part 1 of the company's Phase IIa study in patients with Rheumatoid Arthritis (RA) with high disease activity has been completed.
The study is designed as a placebo-controlled double-blind multicenter study with a 2:1 randomization of once daily dosing of AP1189 vs placebo (ie two patients is treated with AP1189 for each patient treated with placebo) in RA patients referred to rheumatological departments due to uncontrolled disease activity defined as clinical disease activity index (CDAI) higher than 22. AP1189 or Placebo is given once daily for 4 weeks in parallel with the initiation of treatment with the disease modulating anti-rheumatic drug, methotrexate.
"We have during the summer had very good progress in the recruitment to the study, which means that we now have completed recruitment in part 1 of the study. The last patients last visit in part 1 of the study will take place in the first half of October 2020 and will be followed by an interim analysis with a primary focus on safety parameters. We will as previously reported remain blinded" says CSO in SynAct Pharma, Thomas Jonassen, MD.
It is planned to continue in the second part of the study as soon as the decision to the final dose regiment has been selected following the evaluation of the interim analysis. It has previously been reported that it is intended to continue dosing with the 50 mg dose and if the 100 mg dose level is safe and well-tolerated, also to include this in part 2 of the study. In that case, the full study will be conducted in up to 90 patients with up to 30 patients on each of the three dose regimens: 50 mg, 100 mg or placebo.
Together this means that the second part of the study will continue during the autumn and winter on clinical sites in Denmark, Sweden and Norway with the aim to have completed recruitment during the first half of 2020.
We have made a brief analysis on blinded and non-validated data from the patients dosed during the last three months for the 100 mg dose cohort and they confirm what we reported following a blinded review of the first 12 patients dosed at the 50 mg dose level. The blinded data indicates that the compound is safe and well tolerated and we have identified additional patients that not only qualified for the primary read-out defined as a reduction in clinical activity index (CDAI) below 22 but had low disease activity, ie CDAI below 10 at the end of the treatment period. However, it has to be emphasized that all observations are based on blinded, non-validated data, ie it can not be excluded that there is placebo-treated patients among those who showed a reduction in the CDAI-score" says Thomas Jonassen, CSO, SynAct Pharma AB.
SynAct has following the successful exercise of the warrants of series TO 2 in July 2020 funding for the continued clinical development of the AP1189-compound in Phase II in the ongoing studies in RA and Nephrotic Syndrome as well as Study in Covid-19 patients to be initiated subject to authorities approval in the new RESOVIR collaboration setup together with key opinion leaders within resolution therapy.
This information is such information that SynAct Pharma AB is obliged to publish in accordance with the EU Market Abuse Regulation. The information was submitted, through the agency of the below contact person, for publication on September 3, 2020.