SynAct slutför del 1 av klinisk fas II-studie med AP1189 mot
Synact Pharma slutför första delen av klinisk fas 2-studie med
Doseringen har slutförts hos 64 friska försökspersoner. Resultat från studien Bolaget upprepar vid en presentation på Sedermeradagen i Köpenhamn idag att en klinisk fas 1-studie med deras kandidat AP1189 skall "SynAct Pharma Announces Positive Interim Phase 2 Data of AP1189 in Rheumatoid Arthritis" går att läsa i sin helhet på di.se. Du kan läsa vad som att slutföra fas II-studien med AP1189 inom reumatoid artrit samt Proof-of-Concept med AP1189 inom den nya indikationen nefrotiskt 5 (EP publication 3743064) which concerns the use of AP1189 in methods of treating kidney disease, specifically primary nephrotic syndrome, AP1189 is developed as an add-on to MTX to reduce inflammation and support resolution ➜attenuate symptoms and decrease time to resolution ➜reduce need for second line treatment and/or reduce MTX dose 12 AP1189 AP1189 treats inflammation through so-called resolution therapy, which is believed to have a beneficial effect in patients with ARDS. The Phase II study for AP1189 will be double-blind, multi-center, and placebo-controlled. In the study, AP1189 will be examined as a potentially additional therapy for patients with idiopathic membranous nephropathy who have nephrotic syndrome. Description: AP1189 is a biased agonist at receptors MC1 and MC3. This is a multicenter, two-part, randomized, double-blind, placebo-kontrolled, 4-week study with repeated doses of AP1189. The study population will consist of newly diagnosed subjects with severe active Rheumatoid Arthritis, defined with a Clinical Disease Activity score (CDAI) > 22, who are to start up-titration with methotrexate.
Intresset för läkemedelskandidaten har samtidigt varit stort bland investerare, vilket reflekteras i det faktum att den riktade nyemissionen blev kraftigt övertecknad. Det säger vd Jeppe Øvlesen och forskningschef Thomas AP1189 is a biased agonist at receptors MC1 and MC3. Welcome, Customer: Please do not inquire quote if your intended use is for a patient since our products are for research use and for chemical synthesis use, not for human use . A multicenter, two-part, randomized, double-blind, placebo-kontrolled, 4-week study with repeated doses of AP1189. The study population will consist of newly diagnosed subjects with severe active Rheumatoid Arthritis, defined with a Clinical Disease Activity score (CDAI) > … 100 mg AP1189 powder in bottle. The dose of 100 mg AP1189 is selected as the starting dose, though with the opportunity to adjust the dose, based on a blinded evaluation of the pharmacokinetics results following dosing of the first 9 subjects. 2015-04-01 March 18, 2021 SynAct has initiated dosing in part 2 of the clinical Phase II study with AP1189 in Covid-19 infected patients UK version; March 18, 2021 SynAct har inlett dosering i del 2 av den kliniska fas II-studien med AP1189 på Covid-19-infekterade patienter 2021-03-18 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.
SynAct slutför del 1 av klinisk fas II-studie med AP1189 mot
Första kliniska studien, som är en så kallad fas-1-studie, görs på friska försökspersoner och beräknas starta under senare delen av 2016. SynAct Pharma AB ("SynAct Pharma") meddelar härmed att bolaget, tillsammans med prof Mauro Teixeira, MD, PhD, Universidade Federal de Minas, Belo Horizonte, Brasilien och prof. Mauro Perretti, PhD William Heavy Research Institute, Barts och London School of Medicine, Queen Mary University, London, Storbritannien har etablerat ett vetenskapligt samarbete, RESOVIR (resolution i viral 2015-04-01 · In this study, we characterize the small molecule AP1189 as a biased agonist at receptors MC1 and MC3. Although not provoking canonical cAMP generation, AP1189 addition to MC1 or MC3, but not empty vector, transfected HEK293 cells caused ERK1/2 phosphorylation, a signaling responsible for the proefferocytic effect evoked in mouse primary macrophages. Den 5 maj uppdaterade SynAct fas II-studien med AP1189 inom reumatoid artrit.
SynAct Pharma Announces Positive Interim Phase 2 Data of
Genom brygglånefinansieringen har SynAct säkrat kapital avseende en del av den breddade fas II-studiens andra del med AP1189, dvs. den del av studien bolaget initialt har ett behov av att finansiera. Genom denna finansiering är styrelsens bedömning att bolaget kan uppnå flera värdehöjande aktiviteter innan Up to 54 patients will be randomized in a 2:1 ratio to receive AP1189 100 mg or placebo once daily, in addition to standard of care. The primary clinical objective of the study is to show reduction in time to respiratory recovery (i e time to normalization of oxygen saturation on ambient air). AP1189 is a biased agonist at receptors MC1 and MC3. Welcome, Customer: Please do not inquire quote if your intended use is for a patient since our products are for research use and for chemical synthesis use, not for human use .
2020-11-09 · 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. De godkännanden som är nödvändiga från de belgiska myndigheterna och den etiska kommittén är klara. Synact pharma kan nu genomföra den första kliniska studien med läkemedelskandidaten AP1189, utvecklad som en ny potentiell behandling av psoriasisartrit, en form av ledbesvär som drabbar ungefär 30 procent av psoriasispatienterna. BRIEF-Synact To Report About Phase IIA Of AP1189 In Q2 2020, Not Q1. Healthcare.
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Gemensamt för samtliga indikationer är den stora potential man sett att kunna motverka den ofta dödliga SYNACT PHARMA: EPO AVSER GODKÄNNA PATENT FÖR AP1189; 2021-04-13 14:03 · Cision SynAct strengthens IP portfolio - Receives "Intention to Grant" from the European Patent Office for a key patent covering AP1189 English version; 2021-04-13 13:57 · Cision 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. The second part is a randomized double-blind placebo-controlled study in 56 Covid-19 patients at clinical sites at Om AP1189 Verkningsmekanismen för SynAct Pharmas ledande läkemedelskandidat AP1189 är att främja resolution av inflammation genom melanokortinreceptor-aktivering direkt på makrofagerna, vilket minskar den proinflammatoriska aktiviteten hos makrofager, och genom att stimulera så kallad makrofagefferocytos har den en specifik förmåga att rensa inflammatoriska celler (J Immun 2015, 194 AP1189 is a biased MC1r and MC3r that in an animal models of NS mimicking iMN and have shown to induce treatment effect comparable to what has been reported for other MCr agonists and in a head to head study with ACTH showed superior treatment effect with significantly lower levels of proteinuria following 4 weeks treatment (Patent application no: WO/2019/243625) 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 läkemedelskandidaten AP1189, även stor potential att avancera inom NS. För att öka värdeskapandet för AP1189 planerar vi nu att genomföra ytterligare en klinisk fas II-studie inom NS. Baserat på våra lovande resultat i båda indikationer, finner vi denna nya strategi med ytterligare en klinisk studie ytterst lämplig och en Möjligheten för AP1189 att bli en ny behandlingsmetod inom resolutionsterapi bedömer vi som lovande och med vår pågående studie inom RA beräknar vi kunna erhålla Proof-of-Concept för AP1189 under Q1 2021 samt rapportera interimsresultat i slutet av det första kvartalet 2020. läkemedelskandidaten AP1189. Genom brygglånefinansieringen har SynAct säkrat kapital avseende en del av den breddade fas II-studiens andra del med AP1189, dvs.
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SynAct har inlett dosering i del 2 av den kliniska fas II-studien
A multicenter, two-part, randomized, double-blind, placebo-kontrolled, 4-week study with repeated doses of AP1189. The study population will consist of newly diagnosed subjects with severe active Rheumatoid Arthritis, defined with a Clinical Disease Activity score (CDAI) > … 100 mg AP1189 powder in bottle. The dose of 100 mg AP1189 is selected as the starting dose, though with the opportunity to adjust the dose, based on a blinded evaluation of the pharmacokinetics results following dosing of the first 9 subjects. 2015-04-01 March 18, 2021 SynAct has initiated dosing in part 2 of the clinical Phase II study with AP1189 in Covid-19 infected patients UK version; March 18, 2021 SynAct har inlett dosering i del 2 av den kliniska fas II-studien med AP1189 på Covid-19-infekterade patienter 2021-03-18 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. 2020-03-31 As AP1189 does not induce the treatment limiting side effects seen following ACTH treatment, the AP1189 compound could be a very attractive new treatment option in NS. We therefore consider it a major milestone in the development of the compound that we now have a Phase II clinical study up running in the iMN patients says Thomas Jonassen , CSO in SynAct Pharma. 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 2021-04-13 AP1189 is a biased MC1r and MC3r that in an animal models of NS mimicking iMN and have shown to induce treatment effect comparable to what has been reported for other MCr agonists and in a head to head study with ACTH showed superior treatment effect with significantly lower levels of proteinuria following 4 weeks treatment (Patent application no: WO/2019/243625) SynAct Pharma expects to soon receive approval to initiate a Phase II clinical trial in Covid-19 patients with the drug candidate AP1189. In addition, the company sees an opportunity to investigate the candidate’s potential in additional viral diseases.