SynAct Pharma is a clinical stage biotechnology company focused on resolving inflammation with melanocortin biology. Selective activation of the melanocortin system can help the immune system resolve excessive or chronic inflammation. SynAct’s therapeutics are designed to selectively provide anti-inflammatory and pro-resolution effects, so that patients can achieve immune balance and live beyond their inflammation.

AP1189, our product candidate selectively stimulates the melanocortin receptors involved in anti-inflammatory and pro-resolution effects without causing immunosuppression that is associated with most of the available anti-inflammatory therapies. These immunosuppressive approaches can lead to opportunistic infections and other serious side effects.

The company is evaluating AP1189 in three Phase 2 clinical programs: rheumatoid arthritis (RA), idiopathic membranous nephropathy (iMN, a form of nephrotic syndrome), and virus-induced respiratory insufficiency (VIRI) like that seen in COVID-19.

In 2021, SynAct successfully completed Phase 2a trials in early severe RA and in hospitalized patients with COVID-19-induced respiratory insufficiency. Also in 2021, SynAct developed and tested a new oral solid tablet formulation of AP1189 in healthy volunteers, completed 3-month toxicology, and filed additional composition patents that should provide molecule exclusivity past 2040.

The Company initiated Phase 2b development with AP1189 in September 2022, when the first patient was recruited to the clinical study in treatment naïve RA-patients (the EXPAND study).