Brief: SynAct Pharma Updates On Resolve P2a Clinical Trial

SynAct Pharma AB

11/03/2024 08:23

March 11 (Reuters) - SynAct Pharma AB  SYNACT.ST :
    * ANNOUNCED ON SUNDAY OUTCOMES OF INDEPENDENT AUDIT OF
4-WEEK
RESOLVE P2A CLINICAL TRIAL IN RHEUMATOID ARTHRITIS  
    * SAID SAFETY DATA FROM ALL SITES SHOULD BE INCLUDED IN THE
PRODUCT SAFETY BASE 
    * SAID DRUG EXPOSURE, EFFICACY DATA COULD BE UTILIZED FOR
FURTHER
ASSESSMENT EXCEPT FOR DATA FROM ONE SITE
    * IS AWAITING FINAL EFFICACY ASSESSMENTS FROM THE CONTRACT
RESEARCH ORGANIZATION (CRO) WITH THE SITE REMOVED FROM THE
CALCULATIONS 
    * RESOMELAGON CONTINUED TO BE GENERALLY SAFE AND WELL
TOLERATED
RELATIVE TO PLACEBO, ONE SERIOUS ADVERSE EVENT WAS REPORTED 
    * RESOLVE PART A WAS NOT ABLE TO IDENTIFY DOSES OF
RESOMELAGON TO
BE APPLIED IN PART B OF RESOLVE STUDY
    * PHASE 2B DEVELOPMENT OF RESOMELAGON IN DMARD-IR PATIENTS
WILL BE
POSTPONED UNTIL COMPOUND HAS BEEN TESTED IN RELEVANT PATIENTS
    * IS IN DISCUSSION WITH THE CRO WHO RAN THE RESOLVE PART A
STUDY
TO GET THE STUDY DULY REPORTED AND THE PROJECT BACK ON TRACK IN
THE MOST EFFECTIVE WAY

        
 Source text for Eikon:  urn:newsml:reuters.com:*:nMFN4m9vyB
 Further company coverage:  SYNACT.ST  

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