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SynAct Pharma Initiates Phase II Study with AP1189 for the

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. AP1189 -DEVELOPMENT OVERVIEW Start ofclinicalphaseI study (healthy) 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 2021-03-18 · 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.

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). 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.

Press releases SynAct Pharma

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. 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 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). The patients will be enrolled at medical centers in Brazil and in a collaboration between SynAct Pharma, Queen Mary 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.

A Study of the Safety, Tolerability and Efficacy of Treatment With AP1189 in Early RA Patients With Active Joint Disease (SynAct-CS002) The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Brief Summary: 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. 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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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).
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SynAct Pharma initierar RESOVIR: Vetenskapligt och kliniskt

2020 — SynAct Pharma completes part 1 of clinical phase II study with AP1189 in Rheumatoid. Arthritis.