SynAct Pharma to present new data on AP1189 for the treatment of rheumatoid arthritis at ACR Convergence 2021

SynAct Pharma AB (“SynAct”) today announced that an abstract entitled ”AP1189: A Novel Oral Biased Melanocortin Agonist with Anti-inflammatory and Pro-resolving Effect for the Treatment of Rheumatoid Arthritis” has been selected for presentation at the ACR Convergence 2021 conference on November 9. AP1189 is a novel oral available compound with anti-inflammatory and pro-resolving effect with the potential to treat active rheumatoid arthritis (RA).

SynAct Pharma will present the compound’s topline pharmacology and efficacy data at the event. The compound is currently being tested in a double-blind placebo-controlled Phase 2a clinical trial in Europe. The primary aim of the study is to evaluate safety and tolerability and potential treatment effects of the compound relative to placebo.

“We are delighted to get the opportunity to present key data related to AP1189 and the potential treatment effects in RA at the ACR Convergence 2021” said SynAct’s CSO Thomas Jonassen.

The information was submitted, through the agency of the contact person below, for publication on August 20, 2021 

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  
Mail: 
joo@synactpharma.com                                                             Mail: tj@synactpharma.com 

About SynAct Pharma AB  

SynAct Pharma AB conducts research and development in inflammatory diseases. The company has a platform technology based on a new class of drug candidates aimed at acute deterioration in chronic inflammatory diseases with the primary purpose of stimulating natural healing mechanisms. For more information: www.synactpharma.com. 

About AP1189

The mechanism of action of SynAct Pharma ́s lead compound AP1189 is to promote resolution of inflammation through melanocortin receptor activation directly on macrophages, thereby reducing the pro-inflammatory activity of macrophages and by stimulating macrophage efferocytosis, a specific ability to clear inflammatory cells (J Immun 2015, 194:3381-3388). This effect has shown to be effective in disease models of inflammatory and autoimmune diseases and the clinical potential of the approach is currently tested in three clinical phase 2a studies in patients with active rheumatoid Arthritis, nephrotic syndrome and COVID-19 associated respiratory distress.

https://clinicaltrials.gov/ct2/show/NCT04004429?term=AP1189&draw=2&rank=1) https://clinicaltrials.gov/ct2/show/NCT04456816?term=AP1189&draw=2&rank=2

About BEGIN Phase 2 Study

The BEGIN study is a multicenter, two-part, randomized, double-blind, placebo-controlled, 4-week study with repeated doses of AP1189. The study population consist of newly diagnosed subjects with severly active RA (Clinical disease activity score, CDAI >22) who are candidates for methotrexate (MTX) treatment.

The first part of the study that now has been completed consisted of two cohorts. In the first cohort a total of 14 patients were treated with 50 mg AP1189 or placebo oral dosing once daily for 4 weeks as add on treatment to MTX naïve patients. The dosing of MTX given were in the range of 10-25 mg given orally once weekly.

In the second part of the study that was initiated in the week of November 9, 2020, 50 mg AP1189, 100 mg AP1189 or placebo given orally in a 1:1:1 randomization will be dosed once daily for 4 weeks as add on to MTX as in part 1 of the study. The study is being conducted at sites in Denmark, Sweden, Norway, Bulgaria and Moldova.