Significant events in the First Quarter 2017
- SynAct received approval from the Ethics Committee and continued dialogue with the French Medicines Agency.
- The utilisation period of Synact’s series TO 1 subscription options fell during March 2017. The utilisation of the subscription options after the end of utilisation period was approximately 7.8 per cent. SynAct raised approximately SEK 1 million through the subscription options, before issue costs.
Significant events since the end of the period
- SynAct gives notice of the Annual General Meeting on 11 May 2017. More information is available through the Company’s (www.synactpharma.se) and AktieTorget’s (www.aktietorget.se) websites respectively.
- SynAct publishes the annual report for the financial year 2016. The annual report is available through the Company’s (www.synactpharma.se) and AktieTorget’s (www.aktietorget.se) websites respectively
- SynAct is planning a Clinical Phase I study with the candidate drug AP1189 in Belgium instead of France, as previously planned. In conjunction with this, the company has revised its timetable for presentation of the phase I results and the initiation of the Phase II study from before year-end 2017/2018 to the First Quarter of 2018.
- SynAct has obtained all regulatory approvals necessary to start the first clinical study with the candidate drug AP1189. The study will be conducted in Belgium and will commence at the end of May 2017 with the first dosing calculated to take place in early June 2017.
CEO Jeppe Øvlesen has the word
Because the dialogue with the French medicines Agency was much more time-consuming than could be predicted, we decided to submit an application to carry out the first clinical study of the candidate drug AP1189 in Belgium instead. In connection with this, we also revised the timetable for the presentation of the results of phase I and initiation of the Phase II study was revised from “before the New Year 2017/18” to the First Quarter of 2018.
The test application was submitted in April 2017 and we received approval from both the Belgian Pharmaceutical Agency and the Ethics Committee on 10 May 2017 . The study will begin at the end of May 2017 after the remaining practical preparations have been made and the first dosing is planned for the beginning of June 2017. The primary purpose of the study is to evaluate the safety and tolerability of AP1189 in healthy subjects and to study the pharmacokinetics of the substance, i.e. How it is absorbed and metabolized (broken down) by the body. In the first part of the study, AP1189, which is taken orally, will be given in single ascending doses. In a second part of the study, AP1189 will be given in ascending daily doses for up to 14 days. We will also study how food may affect the uptake of AP1189 by the body. In total, up to 108 healthy test subjects will be studied. Results from the study are expected to become available in the First Quarter of 2018.
We are very pleased to have received this long-awaited announcement and that we can initiate the first clinical study with AP1189. The results of the Phase I study will provide both the company and potential commercial partners with valuable information for the further development of AP1189, a new potential promising treatment of the significant proportion of psoriatic patients affected by Severe joint symptoms and where there is still a great need for new safe and effective treatment options.
CEO – SynAct Pharma AB