12 okt. 2020 — SynAct Pharma completes part 1 of clinical phase II study with AP1189 in Rheumatoid. Arthritis. SynAct Pharma AB ("SynAct") today announced 

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The study population will consist of patients with idiopathic membranous nephropathy (iMN) who are on ACE inhibitor or angiotensin II receptor blocker treatment. 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 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 Syndrome (ARDS). SynAct Pharma investigates the possibility of developing its clinical anti-inflammatory lead candidate drug AP1189 as an additional therapy in hospitalized patients with COVID-19 infection, to prevent Acute Respiratory Distress Syndrome (ARDS).

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2020 — Based on the interim analysis, the DSMB recommend continuing into part 2 of the BEGIN study with AP1189 dosed at either 50 mg, or 100 mg  18 mars 2021 — explorativa kliniska fas 2-studien med AP1189 på Covid-19-patienter och professor Mauro Perretti, PhD, William Heavy Research Institute,  07:04 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  2 apr. 2020 — Även om Covid-19 har skapat ett nytt indikationsutrymme för AP1189, to start a study very soon« — Jeppe Øvlesen, CEO SynAct Pharma. M. C., Polizzi, R. B., Teixeira, M. M. & Mota, C. R., 1 maj 2021, I: Water Research. SynAct Pharma Initiates Phase II Study with AP1189 for the Treatment of  1 okt. 2019 — While SynAct will probably await top line-data from the ongoing Phase II study before striking an AP1189 licensing deal in Europe and the US,  SynAct has initiated dosing in part 2 of the clinical Phase II study with AP1189 in Covid-19 infected patients UK version. 17.3.2021, 23:04 · Nyhetsbyrån Direkt  28 aug.

SynAct Pharma AB: Update on SynAct Pharma´s Clinical Phase II study with AP1189 in Rheumatoid Arthritis Wed, Jul 15, 2020 07:25 CET. SynAct Pharma AB ("SynAct") today announces that the company is making progress in the second and final dose level (100 mg) in part 1 in patients with a Rheumatoid Arthritis with high disease activity at clinics in Denmark and Sweden.

The blinded review of the data also indicates a substantial reduction in disease severity among two thirds of the […] 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 AP1189 or placebo is given once daily for 4 weeks. When dosing in this second cohort of the part 1 of the study is completed, the study will continue into part 2 of the study where it already, based on data from a blinded review has been decided to continue with the 50 mg dose. The BEGIN study is designed as a placebo-controlled double-blind multicenter study with a 2:1 randomization ratio of once-daily dosing of AP1189 vs placebo in RA patients referred to 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 given once daily for 4 weeks in parallel with the initiation of treatment with the disease modulating anti-rheumatic drug, methotrexate. "We have during the summer had very good progress in the recruitment to the study, which means that we now have completed recruitment in part 1 of the study.

Ap1189 study

AP1189 treats inflammation through so-called resolution therapy, which is believed to have a beneficial effect in patients with ARDS. 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. 2020-06-30 · AP1189 Study. 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. The aim of the current study is therefore to start treatment as soon as the patients are referred to hospital with the aim to investigate whether AP1189 can promote inflammatory resolution and thereby reduce time to recovery and reduce the risk of development of severe ARDS,” said primary investigator Prof.

Ap1189 study

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Ap1189 study

The experiment takes place in several hospitals. In order to better assess the mechanism of action of the active study drug AP1189, AP1189 is compared to an inactive substance (placebo). 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 dos 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 wi 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 En konkret utvecklingsplan stärker förhandlingspositionen i framtida diskussioner och utgör en viktig del av Synact Pharmas affärsutvecklingsstrategi för AP1189.

2021 — 2020-09-03 08:52:54 SynAct Pharma SynAct Pharma informs that the recruitment to part 1 in the Clinical Phase II study with AP1189 in  12 okt. 2020 — drug AP1189 was successfully completed in the second cohort (100 mg dose level) in part 1 of the company's Phase IIa study in patients with  11 maj 2017 — för en klinisk studie av AP1189, en potentiell behandling av psoriasisartrit.
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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.

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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

SynAct Pharma Initiates Phase II Study with AP1189 for the Treatment of ARDS in COVID-19 Patients SynAct Pharma "SynAct's primary focus is to rapidly determine the safety and efficacy of AP1189 as a potential treatment for COVID-19. The AP1189 study is a double-blind, placebo-controlled multicenter study. For each patient treated with placebo, two patients will be treated with AP1189. In the parallel study in patients with nephrotic syndrome, the drug candidate is given to patients with continuous proteinuria after at least two months of treatment with ACE inhibitors.

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

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. 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 Syndrome (ARDS). AP1189 is an oral, once daily, small molecule melanocortin receptor agonist 5. AP1189 -DEVELOPMENT OVERVIEW Preparatoryactivitiesfor future commercialdeal with AP1189 afterPhaseIIa 6 Start ofclinicalphaseI study (healthy) A Study of the Safety, Tolerability, Pharmacokinetics and Efficacy of Treatment With AP1189 in Patients With iMN.

The second part of the study will be initiated this week according to the DSMB recommendation. Furthermore, we know that it is safe and have the drug available so that we will be able to start a study very soon« — Jeppe Øvlesen, CEO SynAct Pharma The decision to expand the indication of AP1189 is based on the fact that IL-6-inhibitors have been reported as potential treatment alternatives to reduce ARDS in patients with serious Covid-19-inflammation. AP1189 or Placebo is given once daily for 4 weeks in parallel with the initiation of treatment with the disease modulating anti-rheumatic drug, methotrexate. "We have during the summer had very good progress in the recruitment to the study, which means that we now have completed recruitment in part 1 of the study. AP1189 • Conduct the first part of the phase II study in RA with the aim of identifying the doses for the second part of the phase II study.