In December 2016, SynAct Pharma AB (“SynAct”) submitted an application for authorisation to initiate a Clinical Phase I study with the company’s candidate drug AP1189. The application must be approved by two agencies, both by the French Medicines Agency and by the Ethics Committee. The Ethics Committee has given its approval to initiate the clinical study. The dialogue with the French Nedicines Agency has been more time-consuming than expected. Provided that is approval is received by the end of March, however, the study results are still expected to be reported in 2017.
The candidate drug AP1189 has been 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. The timeframe for the implementation of the Phase I study is approximately nine months.
CEO Jeppe Øvlesen comments
“The approval of the Ethics Committee is an important step before the start of our clinical study. We are continuing the dialogue with the French Medicines Agency with the aim of getting the go ahead to begin the study as soon as possible.”
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’s market abuse regulation. The information was submitted by the above contact person for publication on 22 February 2017.
About SynAct Pharma
SynAct Pharma AB develops medication for acute deterioration in inflammatory diseases. The company’s candidate drug AP1189 is intended for the treatment of psoriatic arthritis – a form of acute joint disorder that affects approximately 30 percent of patients suffering from psoriasis.
Preclinical studies show that AP1189 has a unique ability to both reduce inflammation and to accelerate the healing of joint injuries. AP1189 has the potential to be administered in tablet form once daily. Results from the Clinical Phase I study are expected to be available at the end of 2017. The company’s ambition is to then carry out a Phase IIa study, and then sign commercial agreements with one or more major pharmaceutical companies.
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’s market abuse regulation. The information was submitted by the above contact person for publication on 22 February 2017.