SynAct presents initial data from the first part of the Phase II study within RA and gives an update on its progression

  • The first of two tested doses (50 mg) identified to be safe and well-tolerated.
  • The blinded review revealed that patients in the study form two groups based on changes in their clinical disease activity index (CDAI).
  • Based on the safe and well-tolerated first dose (50 mg) the company now initiates the next dose level (100 mg).

SynAct Pharma AB (“SynAct”) hereby announces that the company, based on a blinded review of data from the company´s ongoing Phase II study entitled ”A double-blind, multi-center, 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 identified the first of two tested doses (50 mg) as safe and well-tolerated. Based on these results, the company will continue at the next dose level (100 mg), but due to the COVID-19 pandemic SynAct Pharma is not able to predict how many patients will be included in the next couple of months.

The blinded review from the Phase II study in RA with AP1189 was based on data from the first 12 dosed patients from sites in Denmark and Sweden. In addition to finding that the dose was safe and well-tolerated, the blinded review revealed that patients in the study form two groups based on changes in their clinical disease activity index (CDAI).

During the 4 weeks treatment period, a group of 8 patients, by the end of the treatment period, showed a reduced CDAI score compared to pre-treatment levels with a median reduction of 50%, and a group of 4 patients with a worsening in their clinical status, where the median CDAI-score was increased with 10%. Seven (7) of the eight (8) patients, which showed a reduction in the CDAI-score, went down from high (CDAI-score >22) to moderate (CDAI-score 11-22) or even low (CDAI-score 2.8-10) disease activity. It is emphasized that this data analysis is based on blinded, non-validated data, and that the above reduction in the CDAI-score cannot be directly attributed to patients receiving either placebo or AP1189.

SynAct Pharma has, based on the findings, decided to move on with dosing at the next dose level (100 mg) in part 1 of the study, and to include the 50 mg dose level in part 2 of the study. Moreover, depending on the safety profile and results from the continued dosing at 100 mg per dose in part 1 of the study, it will be decided whether the 100 mg dose shall also be included in part 2 of the study.

In the ongoing study, AP1189 or Placebo is dosed once daily in previously methotrexate (MTX) naïve patients. MTX is given once weekly in increasing doses starting with 10 – 15 mg. The study consists of two parts. In part 1 there are two consecutive cohorts, where the first cohort receives 50 mg in a 2:1 randomization against placebo controls, i.e. 2 patients are treated with AP1189 for each patient treated with Placebo. If this is deemed safe, a second cohort shall receive a 100 mg dose using the same randomisation. In part 2 the dose(s) of AP1189 identified based on data obtained in part 1 will be used. The full study is designed with the aim to include up to 90 patients (up to 60 treated with AP1189, and up to 30 with Placebo).

Prior to the Covid-19 pandemic, the company announced in February that part 1 of the study would be delayed by 3 months, with planned reporting of interim data from the first part of the study in Q2 2020. The Covid-19 pandemic has severely limited recruitment in many clinical studies, but SynAct Pharma has been able to continue some recruitment of patients in Denmark during the pandemic, however at a somewhat reduced recruitment rate, whereas recruitment at Swedish and Norwegian sites is on hold. It is currently unknown when recruitment from sites in other European countries can be initiated. It is therefore unlikely that all patients in the planned 100 mg cohort in part 1 of the study will be enrolled, dosed, and reported in Q2.

The company will update the market with progress and timelines when more clarity on the Covid-19 pandemic situation and its impact on the reopening of sites become available. Despite the Covid-19 uncertainties, SynAct Pharma expects that the cash on hand and the additional funds from the exercise of the options (TO2) 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, where a clinical trial application was filed to the Danish Medicinal Agency in March 2020.

Thomas Jonassen, CSO of SynAct Pharma states:

“We have, based on the blinded data review, decided to go on to dosing at the next dose levels, since the 50 mg dose levels seems to be safe and well-tolerated. In addition, the blinded data review shows that two-thirds of the patients have a reduction in CDAI score. It is a small sample size and we cannot exclude that there are placebo-treated patients among those patients, but we see a signal, which in some patients is quite significant, and the 50 mg dose levels should be tested further in part 2 of the study. It should be emphasized that AP1189 or placebo is given in parallel with methotrexate and that the patients have not been treated with methotrexate before.

Finally, I would like to thank our patients and the investigators who during these difficult days with the Covid-19 pandemic have made it possible to bring the study forward.”

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 May 5, 2020.

For further information about SynAct Pharma AB, please contact:

Jeppe Øvlesen                                                                                Thomas Jonassen

CEO, SynAct Pharma AB                                                                CSO, SynAct Pharma AB

Phone: +45 28 44 75 67                                                                  Phone: +45 40 15 66 69