SynAct Pharma advances trial with boosted funding
In the fourth quarter, SynAct Pharma focused on progressing its Phase IIb study, ADVANCE, evaluating resomelagon in newly diagnosed severe rheumatoid arthritis patients. The company has also secured crucial funding to maintain its momentum. CEO Jeppe Øvlesen discusses the progress in an interview with BioStock.
On February 18, SynAct Pharma published its Q4 report, placing strong emphasis on the significant impact of rheumatoid arthritis (RA) and the large number of people affected by the disease. With over 400,000 newly diagnosed patients annually in the Western world, SynAct Pharma’s drug candidate resomelagon (AP1189) has the potential to address a critical unmet medical need.
RA is a chronic autoimmune disease in which the immune system mistakenly attacks the body’s own tissues, leading to joint pain, swelling, and long-term damage. Resomelagon aims to regulate excessive immune responses by reducing inflammation and activating the body’s natural mechanisms for resolving inflammation.
Clinical trial on track
SynAct Pharma remains confident that resomelagon can make a meaningful difference for RA patients, addressing the large unmet medical need for well-tolerated new treatment options that can be applied in newly diagnosed RA patients. This prompted them to initiate the ADVANCE phase IIb study.
During Q4, the team ensured that the study was initiated with recruitment of patients at clinical sites in the US and in several European countries. The trial is progressing as planned, with enrollment of all 240 patients expected to be completed by Q4 2025.
The study aims to pave the way for phase III development and validate the therapeutic potential of resomelagon, building on previously demonstrated efficacy in the phase IIa BEGIN study and a subset of newly diagnosed patients with systemic inflammation in the phase IIb EXPAND study.
Capital raise
In Q4 and early 2025, SynAct Pharma also bolstered its financial standing, securing SEK 65 million through a combination of a rights issue and directed share issues. This successful funding round, despite challenging market conditions, reflects market confidence in the company’s scientific advancements and strategic direction.
The acquired capital will primarily be allocated to the ADVANCE study and the TXP program, and to explore additional therapeutic applications for resomelagon beyond RA.
Last year, the company also significantly reduced its operating expenses, as reflected in the year-end report. In the fourth quarter, operating expenses totalled SEK 20,79 million, representing a 77 per cent decrease. For the full year, operating expenses amounted to SEK 89,98 million, a decrease of 60 per cent.
Strengthened industry presence
Beyond clinical and financial achievements, SynAct Pharma reinforced its presence in the life sciences sector through active participation in key industry events. In November, the company presented clinical data from the EXPAND study at the American College of Rheumatology (ACR) Convergence 2024 in Washington, DC. Additionally, SynAct attended BIO-Europe in Stockholm, further expanding its network of potential partners and investors.
In January, company representatives travelled to the U.S. for meetings during J.P. Morgan Healthcare Conference, a crucial event for building investor and industry relationships.
CEO looks ahead to 2025
BioStock reached out to SynAct Pharma’s CEO, Jeppe Øvlesen, for his insights on the company’s achievements in the fourth quarter and key milestones ahead.
What were the biggest challenges your team faced during the fourth quarter, and how did you overcome them?
– The team has been running full speed since the start and the fourth quarter was no different. Ensuring the ADVANCE trial was approved and started was critical. We also needed to raise money to financing this trial, and we are fortunate to have so many who see the potential in SynAct and supported us.
Securing SEK 65 million in funding to a premium despite challenging market conditions is a significant achievement. What do you believe instilled such confidence in investors?
– Is it a challenging market, but investors understand the potential of the pipeline and know we have the right team in place and strategy to take resomelagon through the ongoing phase IIb ADVANCE trial. I think a lot of this confidence stems from us aiming to be as candid as possible about our goals. We aim to continue this in 2025.
Can we expect some interim data from the ADVANCE study this year?
– The clinics are working hard to recruit patients, and they are progressing well. What we have said is that we expect to have all 240 patients enrolled in Q4 2025.
To conclude, could you outline SynAct Pharma’s strategic vision for 2025 and beyond?
– We plan to keep up the fast tempo. The ADVANCE trial is progressing, but resomelagon has so much potential in other indications beyond rheumatoid arthritis. We will continue to explore development in other indications where we expect resomelagon to have a chance to support others who are suffering.
The content of BioStock’s news and analyses is independent but the work of BioStock is to a certain degree financed by life science companies. The above article concerns a company from which BioStock has received financing.
