In order to better assess the mechanism of action of the active study drug AP1189 , AP1189 is compared to an inactive substance (placebo). Which treatment the

28 aug. 2020 — Mauro Perretti, PhD William Heavy Research Institute, Barts och London dosering av SynAct Pharmas kliniska läkemedelskandidat AP1189.

2020 — The DSMB recommends that the study continues to Part 2 in which the patients are randomized to 50 mg AP1189, 100 mg AP1189 and 23 sep. 2020 — 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 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 Press releases · March 18, 2021SynAct has initiated dosing in part 2 of the clinical Phase II study with AP1189 in Covid-19 infected patients UK version · March 18, 18 mars 2021 — SynAct Pharma AB ("SynAct") today announced that dosing in the second part of the exploratory clinical Phase 2 study with AP1189 in This study is an exploratory, randomized, double-blind, multicenter, placebo-controlled study with repeated doses of AP1189. The study population will consist of SynAct has initiated dosing in part 2 of the clinical Phase II study with AP1189 in Covid-19 infected patients UK version. SynAct Pharma AB ("SynAct") today SynAct has initiated dosing in part 2 of the clinical Phase II study with AP1189 in Covid-19 infected patients UK version.

Ap1189 study

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 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. SynAct Pharma has 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).

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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

SynAct Pharma AB ("SynAct") today announced that the company has initiated a Phase II clinical study with the AP1189 compound in idiopathic membranous nephropathy patients with Nephrotic Syndrome.. 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 2020-09-03 In the Phase IIa study, AP1189 will be tested in a double-blind, placebo-controlled multicentre study as add-on therapy to ACE-inh ibitor or A ngiotensin-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.

2020-09-23

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. SynAct Pharma has 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 AB ("SynAct") today announced that dosing in the second part of the exploratory clinical Phase 2 study with AP1189 in Covid-19 patients conducted Yesterday, preliminary data from SynAct Pharma’s Phase II study with the drug candidate AP1189 in patients with rheumatoid arthritis was released. The data indicate that AP1189, administered in doses of 50 mg, is safe and well-tolerated. 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.

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. 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.
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The patients will be dosed with either 100 mg 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.

2020 — The DSMB recommends that the study continues to Part 2 in which the patients are randomized to 50 mg AP1189, 100 mg AP1189 and 23 sep.
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In the Phase IIa study, AP1189 will be tested in a double-blind, placebo-controlled multicentre study as add-on therapy to ACE-inh ibitor or A ngiotensin-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. The patients will be dosed with either 100 mg

STOCKHOLM (Direkt) Läkemedelsutvecklaren Synact Pharma har erhållit positiva data från en preklinisk studie inom nefrotisk syndrom (NS) för läkemedelskandidaten AP1189. 2020-11-09 · 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 rheumatological departments due to uncontrolled disease activity defined as a Clinical Disease Activity Index (CDAI) score higher than 22.

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SynAct Pharma has 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).

Yesterday, preliminary data from SynAct Pharma’s Phase II study with the drug candidate AP1189 in patients with rheumatoid arthritis was released.