Below is an overview of SynAct Pharma’s history in brief. SynAct Pharma ApS was formed in 2012. SynAct Pharma AB, the Group’s parent company, was formed in April 2016.
- SynAct Pharma ApS is founded by Dr. Thomas Jonassen and Dr. Søren Nielsen and starts operations based on acquired intellectual property rights and assets from Action Pharma A/S after Action Pharma A/S’s main asset, AP214, was sold to Abbvie Inc.
- SynAct Pharma concludes toxicological, safety pharmacological and metabolism studies.
- Patents are approved in Europe (patents in the US were approved in 2011).
- SynAct Pharma AB is established.
- SynAct Pharma receives approximately SEK 12.7 million through a private placement before issue costs.
- SynAct Pharma receives approximately SEK 32.3 million before issue costs through a new share issue prior to listing on AktieTorget.
- SynAct Pharma’s share is listed on AktieTorget (later Spotlight Stock Market).
- SynAct Pharma finalizes commitments to funding from Seed Fund CAPNOVA through one-off payment.
- SynAct Pharma submits the application for the start of a phase I clinical trial with AP1189 to the French Medicines Agency.
- The Company reports a delay of the Phase 1 clinical study with AP1189 due to a slow process with the French authorities and decides to move the study to a clinic in Belgium.
- The Phase 1 clinical study with AP1189 is initiated in Belgium and SynAct commences preparations for a Phase 2a clinical study with AP1189.
- The Company initiates preclinical studies with AP1189 in several disease models representative of diseases in which ACTH (adrenocorticotropic hormone) treatments are currently used (such as arthritis and NS).
- The company carries out a rights issue of approximately SEK 22.4 million for the extended development program for AP1189.
- The company announces that the tablet formulation of AP1189 used in the initial clinical Phase 1 study was found to give rise to excessively high variance in plasma concentration, which leads to further development with this tablet formulation being discontinued and the company continuing the development of AP1189 with an oral suspension.
- Recruitment and dosing of patients in a Phase 2a clinical study with the drug candidate AP1189 in patients with active arthritis begins.
- A rights issue of approximately SEK 30 million is carried out
- The Company investigates AP1189 in patients with COVID-19 and nephrotic syndrome.
- SynAct Pharma publishes positive interim data from the Phase 2a study with AP1189 in rheumatoid arthritis.
- SynAct Pharma carries out a directed share issue of SEK 80 million
- SynAct Pharma publishes positive data from the Phase 2 study with AP1189 in COVID-19.
- A new tablet formulation for AP1189 is developed and clinical testing is initiated.
- The Company announces a delay, among other things caused by COVID-19, and takes the decision to redesign its clinical phase 2a study with AP1189 in iMN.
- Positive results from the Phase 2a study with AP1189 in patients with active RA, BEGIN, is reported.
- The Company carries out a rights issue of approximately SEK 150 million.
- Clinical pharmacokinetic tests with AP1189 as a tablet are successfully completed.
- The Company’s shares are listed on the mid-Cap segment at Nasdaq Stockholm’s main market.
- The Company initiates the EXPAND Phase 2b clinical study with AP1189 in treatment naïve RA patients with severe disease activity.
- The company successfully files and IND with the FDA and initiates the RESOLVE Phase 2a/b trial with AP1189 in patients who have an incomplete response to methotrexate
- The company announces the intention to acquire TXP Pharma AG and its portfolio of melanocortin agonists and simultaneously announces a directed rights issue of SEK 80 million.
- The shareholders vote to approve the proposed acquisition of TXP Pharma.