SynAct Pharma’s Chairman: ”We are confident we have the right strategy”
SynAct Pharma’s Capital Markets Day provided detailed information regarding the revised strategy for its lead asset, resomelagon. The company focuses on the phase IIb ADVANCE study in early, severe rheumatoid arthritis, which is now up and running in the US. In parallel, the company is engaging in partnering discussions to strike a deal for phase III studies and beyond.
– SynAct has a clear strategy, the right team and fresh funding to continue with its plan, says Anders Kronborg, Chairman of the Board.
SynAct Pharma’s lead drug candidate, resomelagon (AP1189), promotes resolution of inflammation through selective activation of the melanocortin system. The compound is primarily being developed for treating rheumatoid arthritis (RA), but also holds potential for the treatment of other autoimmune and inflammatory diseases.
On September 23, SynAct Pharma hosted a Capital Markets Day in Stockholm with several presentations from management and key stakeholders. The event opened with a brief introduction by Jeppe Øvlesen, who resumed the role of CEO earlier this year following the board’s restructuring.
– Despite a rocky road, we are now fully back on track. We have money in the bank and the study has started, Jeppe Øvlesen said in his introduction at the Capital Markets Day.
Refocused strategy and new trial
In March, SynAct Pharma raised 50 MSEK through a directed share issue while reducing management and board-related costs. The updated board and management team introduced a revised strategy for resomelagon, with focus on the development track in newly-diagnosed severe rheumatoid arthritis (RA) initiated with the BEGIN study in 2020 where the compound now is entering into phase IIb in a trial called ADVANCE.
Patient recruitment for the ADVANCE study has begun at US sites, while clinical trial applications in Europe are still pending approval. SynAct Pharma plans to recruit patients at more than 20 sites in seven countries in Q4 2024. The study will include a total of 240 newly diagnosed patients showing signs of severe RA, including signs of systemic inflammation. The patients will be given either placebo or one of three doses of resomelagon once daily for 12 weeks in combination with first-line treatment, methotrexate (MTX).
Following the phase IIb study, SynAct Pharma plans to secure a partnership for phase III trials, as outlined by Chairman Anders Kronborg during his CMD presentation. Consequently, business development will be a key focus area over the coming months, in parallel with the ADVANCE trial.
Resolution therapy – potential gamechanger in RA treatment
The Capital Markets Day also featured a presentation from Professor Mauro Perretti, who provided valuable insights into the dynamics of inflammation and the potential of SynAct Pharma’s resolution technology. He specifically highlighted the significant challenges with current anti-RA therapies, noting that a substantial proportion of patients fail to respond to treatment. Additionally, existing therapies are associated with side effects such as immunosuppression, increased risk of infections, and even cardiovascular events and cancer.
Professor Perretti emphasised the advantages of resomelagon’s pro-resolution mechanism compared to immunosuppressive anti-inflammatory therapeutics. Resolution-based therapies mimic the way our body naturally resolves inflammation, instead of inhibiting the immune system. According to Perretti, this approach could potentially provide an “180 degree shift” in the treatment of RA and other chronic inflammatory diseases.
Asger Reinstrup Bihlet, CSO at Sanos Group – SynAct Pharma’s CRO partner and largest shareholder – gave an overview over the current treatment options in early RA showing that there is considerable room for improvement in the treatment of RA, and that new safe and effective treatments are needed. He emphasised that new treatments should be safe, immunopreserving, simple to use, offer at least comparable or additional efficacy, and highlighted that resomelagon had the potential to fulfil such a need.
Focus on newly diagnosed patients with high diseases activity
Furthermore, SynAct Pharma’s CSO Thomas Jonassen provided an update on the company’s pipeline, with focus on development of resomelagon in RA.
– The company started development of RA in newly diagnosed RA patients with high disease activity in the successful BEGIN study where the compound in combination with MTX showed very promising statistically significant treatment effects and a very good safety profile, Jonassen explained.
It was further explained how lessons from the next two clinical trials had emphasized that development of the compound should be focused on newly diagnosed RA patients with high diseases activity, including signs of systemic inflammation. The positioning of the compound as a new treatment option for such patients was further explained and the study design of the new now ongoing phase IIb ADVANCE study was presented.
First-line treatment in combination with MTX
The ADVANCE study is conducted to show the treatment effect of resomelagon in combination with MTX. Jonassen explained that MTX monotherapy often is inadequate for managing RA, and that glucocorticoids are frequently needed to achieve better disease control.
SynAct Pharma’s CBO Jim Knight emphasised that RA patients with high disease activity at diagnosis generally have a poorer disease prognosis and can be less responsive to MTX, which further supports the development of resomelagon as first-line treatment in addition to MTX in early, severe RA. Knight highlighted that around 200,000 newly diagnosed RA patients annually in US and Europe are present with symptoms that potentially could benefit from resomelagon treatment.
Chairman shares additional insights
BioStock contacted Anders Kronborg, Chairman of the Board, to learn more about SynAct Pharma’s refocused strategy.
You assumed the role of Chairman of the Board at SynAct Pharma earlier this year. How would you describe your first months in this position?
– It has certainly been exciting, that is the short version. We spent the first months looking very closely at that strategy to ensure it was strong and to the point as possible. The company also raised the needed capital and aligned the first action plan together with management. SynAct has a clear strategy, the right team and fresh funding to continue with its plan.
According to you, what were the key highlights during the company’s Capital Markets Day?
– Our main goal was to present a very clear and straight forward development strategy for resomelagon as a new patient friendly treatment option to newly diagnosed RA patients where there is a clear unmet medical need. We also heard from our Chief Business Officer Jim Knight about the significant market potential and continued interest from potential partners. The company has a clear strategy, and it is important to make sure the market understands our path forward and the upcoming milestones so it can track our progress.
SynAct Pharma’s current strategy differs somewhat from what the previous board and management had planned. What makes you believe that this new approach is more optimal?
– We are confident we have the right strategy to make SynAct a success. The faster resomelagon is introduced to the patients the more the patients would benefit from the treatment. The current strategy is based on the compound mode of action and very promising clinical data generated in the BEGIN study and in the right patients in the EXPAND study.
– The positioning of the compound is done within the current treatment guidelines as an add on to existing treatments where there is a very clear need for new treatment options.
– Simply speaking, we see the compound as a patient friendly – i.e. good safety, oral treatment, effective- new treatment option, in patients suffering for high diseases activity, where the current treatment options are associated with side-effects, issues with dose titration, early changes in treatment, too many clinical visits and too many blood samples.
SynAct Pharma plans to secure a partnership for the phase III study once the ADVANCE data become available. How do you envision this partnership being formed?
– We have continued our dialogs with the potential partners that were lined up at the last data point, and I am happy to say that they all remain interested. As part of these discussions, we have been getting valuable feedback and input to the study design, improving our chances of doing an optimal deal at the next data point. We have regular meetings to update partners on our progress, and we will participate in BIO-Europe, BIO US and JP Morgan as well.
– In focusing on first line, we have seen the possibility to broaden our scope also to include more specialized pharmas – still targeting a USD 2 billion plus market potential.
