February 18, 2024

SynAct Pharma was running at full speed during the fourth quarter. The team has done a fantastic job ensuring our Phase 2b ADVANCE study in patients with newly diagnosed severe rheumatoid arthritis (RA) was ready to start recruiting patients, while we also worked with investors to bring in new funding and build relationships for the company’s future growth.

It’s worth taking a moment to remind the market what RA is and just how many suffer globally each year from this disease. RA is a chronic disease of the joints with active phases called flares, characterized by immune cell invasion, pain and reduced joint function. The inflammation that occurs is the immune system’s way of responding to infections and injuries. While the immune system typically deactivates after the invading pathogen is removed or an injury heals, in some cases the inflammation can be excessive or chronic, overwhelming the body’s ability to turn off the response. This can lead to pain, tissue destruction and loss of function.

When the immune system is overwhelmed, therapies like resomelagon (AP1189) may help resolve inflammation by providing both anti-inflammatory activity and by triggering the immune system’s natural inflammatory resolution mechanisms. There are more than 400,000 newly diagnosed patients each year in the Western world and many of these sufferers could benefit from treatment with resomelagon as a new effective and safe treatment.

We are confident resomelagon can make a difference for many of these RA patients, and that pushed us to start the ongoing Phase 2b ADVANCE study during the quarter. The ADVANCE trial is on track, and we still expect to have all 240 patients enrolled in Q4 2025.

The goal of the ADVANCE study is to confirm the treatment potential of the compound, previously reported in the BEGIN study and in the subset of newly diagnosed patients with signs of systemic inflammation in the EXPAND study, and to identify optimal doses for Phase 3 development in patients with newly diagnosed RA.

Continued trust from shareholders and continued business development

To support the continued development of resomelagon in the ADVANCE study, SynAct raised SEK 65 million from current and new shareholders. Raising this type of funding during such difficult times for the life science sector highlights the trust many have for our science and our efforts to execute on our strategy.

Most of this new funding will be used to finance the ADVANCE study and the TXP program, while a portion will also be used to explore development in other indications where we see great potential for resomelagon. Ensuring the RA trial stays on track is key, but there are other diseases where activating the melanocortin system can potentially make a big impact.

In November, SynAct presented clinical data from the Phase 2b EXPAND study at the American College of Rheumatology (ACR) Convergence 2024 in Washington DC, USA and in November we joined BIO-Europe in Stockholm. We also traveled to the US in January to have meetings during the large J.P. Morgan Healthcare conference. We are encouraged by the interest in resomelagon and will keep working at building these key relationships.

The SynAct team has kept busy, and we plan on keeping a fast pace in 2025. We are very grateful to those helping with the ADVANCE trial and to all of our shareholders who continue to give us their support.

Many thanks for showing interest in SynAct.

Jeppe Øvlesen | CEO and Board Member