SynAct has initiated dosing in part 2 of the clinical Phase II

Norra Skåne Syn Act slutför del 1 av klinisk fas II studie med AP1189

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The first part of the study, which is an open-label study in 6 patients to evaluate the safety of the compound in a specific clinical setting, will be initiated as soon as medicine for the study has arrived at the I am indeed happy that we have started the second phase of the study 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 at Universidade Federal de Minas, Belo Horizonte, Brazil. SynAct Pharma expects to soon receive approval to initiate a Phase II clinical trial in Covid-19 patients with the drug candidate AP1189.

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Press releases SynAct Pharma

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 mechanism of action of SynAct Pharma´s lead compound AP1189 is to promote resolution of inflammation through melanocortin receptor activation directly on macrophages, thereby reducing the pro-inflammatory activity of macrophages and by stimulating so-called macrophage efferocytosis, a specific ability to clear inflammatory cells (J Immun 2015, 194:3381-3388). 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 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 The AP1189 compound is a biased melanocortin receptor agonist developed for once daily oral dosing and is currently tested in Phase 2 clinical trials in Rheumatoid Arthritis and Nephrotic Syndrome. “We have recently had good progress in the study in patients with Rheumatoid Arthritis where the compound is tested in treatment naïve patients with severe active disease as an add on to Methotrexate treatment. 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.

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