SynAct Pharma AB (”SynAct”) SynAct is planning a Clinical Phase I study with the candidate drug AP1189 in Belgium instead of France, as previously planned. The reason is that the company wants to minimise the delay in starting the study, which arose as a result of the dialogue with the French Medicines Agency being more much time-consuming than could have been predicted. 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 New Year 2017/18” to the First Quarter of 2018. However, the company still thinks that Phase II results may be presented in 2018.
In December 2016, SynAct submitted an application to the French Medicines Agency and the relevant Ethics Committee for authorisation to initiate a Clinical Phase I study with the company’s candidate drug AP1189 . The Ethics Committee gave its approval for study start in February 2017, but the dialogue with the French Medicines Agency has been much more time-consuming than expected. For this reason, the company has decided to carry out the study in a clinic in Belgium instead. SynAct has submitted applications to the Belgian Medicines Agency and a local Ethics Committee, and the company considers that these will be processed by the authorities by the beginning of June 2017. In event of a positive outcome, the study can be initiated during the same month and the results available in the First Quarter of 2018. Financing of the clinical development of AP1189, up to the reporting of the planned Phase IIa study, is still judged to be possible with existing cash funds.
CEO Jeppe Øvlesen comments
”Through the measures taken, there is a good chance to minimise the delay in the development of our candidate drug AP1189. We still consider that the Phase II data intended to form the basis for a sale or out-licensing of the project could be available at the end of 2018 ”.
The candidate drug AP1189 is being developed for the treatment of psoriatic arthritis and has shown positive effects in a number of preclinical disease models. The primary purpose of the phase I clinical study was to evaluate the safety and tolerability of AP1189 in healthy subjects and to study its pharmacokinetics, i.e. How it is absorbed and metabolized (broken down) in the body.
For further information about SynAct Pharma AB, please contact:
Jeppe Øvlesen Thomas Jonassen
CEO, SynAct Pharma AB CSO, SynAct Pharma AB
Telephone: +45 28 44 75 67 Telephone: +45 40 15 66 69
E-mail: [email protected] E-mail: tj@synactpharma.com
This is information that SynAct Pharma AB is obliged to disclose under the EU market abuse regulation. The information was submitted by the above contact person for publication on 25 April 2017.
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