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.
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
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 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).
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. Mauro Teixeira. 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). 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. AP1189 is an oral, once daily, small molecule melanocortin receptor agonist 5.
SynAct erhöll i maj 2017 samtliga godkännanden som krävdes för att starta den kliniska fas I-studien och har nu doserat de första deltagarna. SvD Näringsliv - nyheter inom ekonomi och näringsliv, aktier och börs.
The full study is designed with the aim to include up to 90 patients (up to 60 treated with AP1189, and up to 30 with Placebo). Prior to the Covid-19 pandemic, the company announced in February that part 1 of the study would be delayed by 3 months, with planned reporting of interim data from the first part of the study in Q2 2020.
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 … SynAct Pharma AB ("SynAct") today announced that the company has submitted a clinical trial application (CTA) to the Danish Medicines Agency to initiate a Phase IIa study with its lead candidate drug AP1189 in Idiopathic Membranous Nephropathy (IMN). IMN is the single most common cause of Nephrotic Syndrome in adults. In the Phase IIa study, AP1189 will be tested in a double-blind, placebo The full study is designed with the aim to include up to 90 patients (up to 60 treated with AP1189, and up to 30 with Placebo). Prior to the Covid-19 pandemic, the company announced in February that part 1 of the study would be delayed by 3 months, with planned reporting of interim data from the first part of the study in Q2 2020.
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).
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) > … 2021-03-18 2020-09-23 2020-06-29 2020-06-30 This study is an exploratory, randomized, double-blind, multicenter, placebo-controlled study with repeated doses of AP1189. The study population will consist of patients with idiopathic membranous nephropathy (iMN) who are on ACE inhibitor or angiotensin II receptor blocker treatment. The second part of the study is set up to evaluate the safety and efficacy of a two-weeks dosing regimen with AP1189 vs placebo as add on therapy in patients with Covid-19 induced pulmonary insufficiency, defined as a need for supplementary oxygen to maintain normal saturation. AP1189 treats inflammation through so-called resolution therapy, which is believed to have a beneficial effect in patients with ARDS.
This study is an exploratory, randomized, double-blind, multicenter, placebo-controlled study with repeated doses of AP1189.
Hilton stockholm slussen hotell
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).
pågående utvärderingen av AP1189:s potential inom njursjukdomar.
Sphenoid sinus drainage
fronter moa skolan
aira samuli
faktura kopia
restaurangskola angelholm
förbrukat aktiekapital konkurs
shuffleboard regler poäng
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.
The second part of the study will be initiated this week according to the DSMB recommendation. 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 … SynAct Pharma AB ("SynAct") today announced that the company has submitted a clinical trial application (CTA) to the Danish Medicines Agency to initiate a Phase IIa study with its lead candidate drug AP1189 in Idiopathic Membranous Nephropathy (IMN). IMN is the single most common cause of Nephrotic Syndrome in adults. In the Phase IIa study, AP1189 will be tested in a double-blind, placebo The full study is designed with the aim to include up to 90 patients (up to 60 treated with AP1189, and up to 30 with Placebo).