SynAct Pharma AB ("SynAct") today announced that dosing in the second part of the exploratory clinical Phase 2 study with AP1189 in Covid-19 patients conducted under the RESOVIR collaboration has been initiated following completion of the initial open label part of study.

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SynAct Pharma Initiates Phase II Study with AP1189 for the Treatment of ARDS in COVID-19 Patients Wed, Sep 23, 2020 08:28 CET. SynAct Pharma AB ("SynAct Pharma") today announced the initiation of a Phase II clinical study to evaluate the safety and efficacy of the company’s lead candidate drug AP1189 in adults diagnosed with COVID-19 and with early signs of Acute Respiratory Distress

”AP1189 har first-in-class”-potential eftersom det idag inte finns någon befintlig behandlingsmetod som fungerar tillräckligt väl med de gamla verkningsmekanismerna”, säger Jeppe Ølvesen. Bakom SynAct Pharma finns en kompetent ledning och styrelse som har dokumenterad erfarenhet inom läkemedels- och affärsutveckling. SynAct Pharma AB ('SynAct') meddelar idag att den kliniska fas I-studien av läkemedelskandidaten AP1189 nyligen har avslutats med positiva resultat och att planering pågår inför den första fas Effektdata indikerade en effekt av AP1189 på reumatoid artrit som var större än placebo (kan också vara dosberoende), och antalet patienter som gick från svår till måttlig Clinical Disease Activity Index (CDAI) var högre i båda behandlingsgrupperna än i placebogruppen. I kombination med det lyckade utvecklingsarbetet avseende AP1189 inom reumatoid artrit (RA) planerar SynAct att genomföra ytterligare en klinisk fas II-studie inom nefrotiskt syndrom (NS). Genom att addera ytterligare en klinisk fas II-studie med AP1189 inom NS bedömer styrelse och ledning i SynAct att bolaget kommer att diversifiera risken och öka det kommersiella värdet för AP1189 or placebo is dosed once daily for 4 weeks in parallel with the initiation of a treatment with the disease-modulating, anti-rheumatic drug methotrexate (MTX).

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In the present study, we  3 apr 2020 SynAct Pharma ansöker om patent för AP1189 inom COVID-19. SynAct Pharma AB ("SynAct") meddelar härmed att bolaget har lämnat in en  9 Jun 2010 Action Pharma develops AP1189 for oral treatment of systemic inflammatory diseases such as rheumatoid arthritis, inflammatory bowel  28. apr 2020 safety, tolerability, and efficacy of 4 weeks of treatment with AP1189 in early rheumatoid arthritis (RA) patients with active joint disease. FILTRON: AP1189.

29. jun 2020 Biotekselskabet Synact Pharma har sat gang i et fase 2-studie med midlet AP1189 mod nefrotisk syndrom. Category: News.

"We have recently had good progress in the study in patients with Rheumatoid Arthritis where the compound is tested in treatment naïve patients with severe active disease as an add on to 2021-04-13 2020-02-06 Spafilter Haven Spas 817-0050, Waterway Front Access Skimmer | AP1189 | Aquaplezier BV Aquafilter Dual Core filter spa filter afmetingen : Diameter (cm): 15,2 Lengte (cm): 19,4 cm Bovenzijde (cm): Handvat Onderzijde (cm): 3,8 SAE grove schr.dr. Filter oppervlakte (sq/ft): 50 SynAct Pharma AB ("SynAct") hereby announces that the company has filed a patent application to the European Patent Office (EPO) covering the use of AP1189 for the treatment of COVID-19 infection, including Acute Respiratory Distress Syndrome (ARDS) and … 2015-11-01 SynAct Pharma AB, a clinical stage biopharmaceutical company developing novel therapies of inflammatory diseases, today announced that an independent Data Safety Monitoring Board (DSMB) has reviewed unblinded and validated data from part 1 of the company's Phase 2a study in patients with rheumatoid arthritis (RA) with high disease activity with the aim to recommend which dose(s) of AP1189 … SynAct Pharma Announces Positive Interim Phase 2 Data of AP1189 in Rheumatoid Arthritis. Nov 9, 2020.

A Study of the Safety, Tolerability and Efficacy of Treatment With AP1189 in Early RA Patients With Active Joint Disease (SynAct-CS002) 

AP1189 är en så kallad first-in-class "biased" agonist på melanocortinreceptorer av typ 1 och 3 för oral administrering en gång per dag. Profilen av föreningen skiljer sig därigenom från andra melanokortinreceptoragonister, eftersom AP1189 på ett mer selektivt sätt stimulerar de relevanta receptorerna i immunsystemet, varigenom oönskade biverkningar kan undvikas. AP1189 is new chemically-synthesized small molecule drug for the treatment of Rheumatoid arthritis (RA). Through specific activation of the patients’ self-anti-inflammatory mechanisms, our first drug candidate renders unprecedent combination of safety, effectiveness and patient compliance, without the side effects associated with current therapies. Fas I-studien med AP1189, som nu är avblindad, fokuserade på att studera säkerhet och tolerabilitet samt farmakokinetiska egenskaper med AP1189 hos friska individer.

In the Phase IIa study, AP1189 will be tested in a double-blind, placebo-controlled multicentre study as add-on therapy to ACE-inhibitor or Angiotensin-2 receptor antagonists in a once-daily dose regimen for four weeks with the primary purpose to show treatment effect on urinary protein excretion relative to pre-treatment levels and placebo. AP1189 or placebo is dosed once daily for 4 weeks in parallel with the initiation of a treatment with the disease-modulating, anti-rheumatic drug methotrexate (MTX). The full study consisting of part 1 and 2 will include up to 90 patients. The second part of the study will be initiated this week according to the DSMB recommendation. The DSMB recommends that the study continues to Part 2 in which the patients are randomized to 50 mg AP1189, 100 mg AP1189 and placebo plus methotrexate (MTX) Full Phase 2 topline data is expected by the end of Q2 2021; LUND, Sweden, Nov. 9, 2020 /PRNewswire/ — The AP1189 compound is a biased melanocortin receptor agonist developed for once daily oral dosing and is currently tested in Phase 2 clinical trials in Rheumatoid Arthritis and Nephrotic Syndrome. "We have recently had good progress in the study in patients with Rheumatoid Arthritis where the compound is tested in treatment naïve patients with severe active disease as an add on to 2021-04-13 2020-02-06 Spafilter Haven Spas 817-0050, Waterway Front Access Skimmer | AP1189 | Aquaplezier BV Aquafilter Dual Core filter spa filter afmetingen : Diameter (cm): 15,2 Lengte (cm): 19,4 cm Bovenzijde (cm): Handvat Onderzijde (cm): 3,8 SAE grove schr.dr. Filter oppervlakte (sq/ft): 50 SynAct Pharma AB ("SynAct") hereby announces that the company has filed a patent application to the European Patent Office (EPO) covering the use of AP1189 for the treatment of COVID-19 infection, including Acute Respiratory Distress Syndrome (ARDS) and … 2015-11-01 SynAct Pharma AB, a clinical stage biopharmaceutical company developing novel therapies of inflammatory diseases, today announced that an independent Data Safety Monitoring Board (DSMB) has reviewed unblinded and validated data from part 1 of the company's Phase 2a study in patients with rheumatoid arthritis (RA) with high disease activity with the aim to recommend which dose(s) of AP1189 … SynAct Pharma Announces Positive Interim Phase 2 Data of AP1189 in Rheumatoid Arthritis.
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Vissa formaliteter måste fortfarande följas innan AP1189-föreningen är en biased melanokortinreceptoragonist utvecklad för oral dosering en gång dagligen och studeras för närvarande i kliniska fas II-studier i reumatoid artrit och nefrotiskt syndrom. En allvarlig följd av infektion med COVID-19 är svår lunginflammation som kan leda till akut respiratoriskt stressyndrom (ARDS) och påföljande behov av respiratorbehandling. Tidigare i veckan kunde SynAct Pharma meddela att bolaget avser positionera sin kliniska antiinflammatoriska läkemedelskandidat AP1189 som tilläggsterapi hos inlagda patienter med COVID-19-infektion, för att 2021-04-13 · SynAct has received information that the company obtained an “Intention to grant” from the EPO regarding their patent application 19734023.5 (EP publication 3743064) which concerns the use of AP1189 in methods of treating kidney disease, specifically primary nephrotic syndrome, including membranous nephropathy as is currently tested in clinical trials.
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En studie av säkerheten, toleransen och effekten av behandling med AP1189 hos tidiga RA-patienter med aktiv ledsjukdom. En dubbelblind, multicenter, tvådelad, 

Resolution therapy is a new method of inhibiting the immune system more selectively, which allows for better maintenance of the immune system’s function so that the patient has more opportunities to cope with the infection through his or her immune system.