Highlights from SynAct Pharma’s Capital Markets Day
On May 5, SynAct Pharma held a Capital Markets Day in Stockholm featuring presentations from the management team, as well as Key Opinion Leaders in inflammation resolution and rheumatoid arthritis. The presentations highlighted the unmet medical need in rheumatoid arthritis and validated the potential of SynAct Pharma’s drug candidate resomelagon in that area, but also in other diseases characterised by inflammation. BioStock contacted Torbjørn Bjerke to hear his highlights from the day.
SynAct Pharma is a biotech company within the field of inflammation resolution for the treatment of inflammatory and autoimmune diseases. The company harnesses the melanocortin system to stimulate both anti-inflammatory activity and the body’s natural inflammation resolution mechanisms. The company’s lead drug candidate resomelagon (AP1189) promotes pro-resolution by selective activation of melancortin receptors 1 and 3.
Q1 report confirms progress
Last year, the company initiated a phase IIb study with AP1189 in patients with early severe rheumatoid arthritis (EXPAND) and a phase IIa/b study in DMARD-IR RA patients (RESOLVE). The latter study is conducted under an Investigational New Drug (IND) application with clinical sites in the US and Europe, which is important for discussions with potential partners.
SynAct Pharma recently published its Q1 report where it stated that the EXPAND and RESOLVE studies are progressing as planned. The company looks forward to presenting top-line data from both studies in the second half of 2023. In parallel, SynAct is conducting a phase IIa study with AP1189 in nephrotic syndrome.
Capital Markets Day
To provide the market with more information on the development, SynAct Pharma recently arranged a Capital Markets Day in Stockholm. Around 60 investors, analysts and journalists participated and another 300 attended the live broadcast – watch it here.
The day started with an introduction from current CEO Jeppe Øvlesen, followed by a corporate update from Torbjørn Bjerke, Chairman and new CEO effective from the Annual General Meeting on May 25. In a Q&A, he mentioned that the company has enough funding to take the current studies to the finish line and that data is expected within five months.
Professor Mauro Perretti explained inflammation resolution
The next presenter was Mauro Perretti, Professor in immunopharmacology and essential in understanding the mechanism of action of AP1189. At the Capital Markets Day, Professor Perretti he explained the mechanism behind inflammation resolution and how it can be harnessed to develop therapeutics for chronic inflammation.
Resolution therapies have the potential to give broad action, without suppressing the immune system as many current treatments do. Professor Perretti explained that current drugs for inflammatory diseases usually block specific pro-inflammatory mediators, while AP1189 resolve the inflammation by a natural inflammatory resolution mechanism.
Broadened opportunities after the acquisition of TXP Pharma
Then CSO Thomas Jonassen entered the stage to talk about the preclinical peptides acquired from TXP Pharma. The expanded portfolio allows development of drugs in a wide range of autoimmune and inflammatory diseases. SynAct will initially put focus on critical care, rheumatology and ophthalmology. The lead candidate, TXP-11, has completed toxicology studies and is expected to advance into a phase I clinical trial in postoperative organ dysfunction in 2024.
Unmet medical need according to Dr. Kivitz
Several speakers during the Capital Markets Day highlighted the unmet medical need in rheumatoid arthritis, especially Dr. Alan Kivitz, President at Altoona Arthritis and Osteoporosis Center and principal investigator in the RESOLVE study with AP1189.
Today, the treatment goal is to reach remission, i.e. no or low disease activity. First-line therapy has become more aggressive and the patients are treated early with methotrexate or other DMARDs. Biological drugs are usually given as an add-on treatment.
However, a big proportion of patients do not respond satisfactorily to the current treatments. 70 per cent of the patients treated with DMARD do not achieve remission and require dose escalation. Diminished efficacy and side effects are common problems that can prevent further treatment. However, there is also a risk of leaving active inflammation uncontrolled since it can lead to joint damage and disability, cardiovascular problems and increased risk of cancer.
According to Dr. Kivitz, there is a need for new oral therapies for RA patients with inadequate response to DMARDs, especially since the JAK inhibitors have received black box warnings due to increased risk of cardiovascular events and cancer.
AP1189 – welcome addition
Novel oral therapies without the toxicities would be a welcome addition – and this is where SynAct Pharma’s AP1189 can play a significant role. No emerging safety issues have been observed so far, according to CBO Jim Knight’s presentation at the Capital Markets Day. Furthermore, he emphasized that AP1189 can resolve inflammation without causing immunosuppressive which makes it suitable for broad use in RA.
The initial clinical results have been encouraging for AP1189 and warrant further development to learn more about appropriate positioning in the RA market. Dr Kivitz also sees potential for AP1189 in other diseases like psoriatic arthritis, ankylosing spondylitis, systemic lupus and Sjogren’s syndrome.
Comments from Torbjørn Bjerke
The Capital Markets Day finished off with a wrap-up from Torbjørn Bjerke, Chairman and soon-to-be CEO. BioStock contacted Bjerke to hear his thoughts on the event.
What message would you like people to take away from the Capital Markets Day?
– SynAct is gearing up for the next big phase of growth. We are expecting results from our EXPAND and RESOLVE studies in the second half of this year, a critical time for SynAct as these studies are important for our discussions with potential business partners.
– Our CMD was an opportunity to invite all of our shareholders to meet and listen to our management team lay out our path forward and for them to hear first hand about the science of melancortin receptors and inflammation resolution from Professor Mauro Perretti and about the large unmet needs in rheumatoid arthritis around DMARD therapies from Dr. Alan Kivitz. Plus, it was a chance for us to share more information on our pre-clinical MC peptides. There was a lot of ground to cover.
»Our CMD was an opportunity to invite all of our shareholders to meet and listen to our management team lay out our path forward and for them to hear first hand about the science of melancortin receptors and inflammation resolution from Professor Mauro Perretti and about the large unmet needs in rheumatoid arthritis around DMARD therapies from Dr. Alan Kivitz.«
– SynAct has the right team in place to take advantage of the data later this year and help ensure the company has the right development pipeline in place for future growth. I’m grateful so many took time to participate.
Recently, the company announced several changes in the management and the board. What was the reason behind the changes?
– The time was right. Jeppe is an entrepreneur at heart and he spent years helping take SynAct to where it is now with exciting data around the corner, being listed on the main market in Stockhom and rallying shareholders to believe in the company. Jeppe was ready to step back from his role as CEO and I have a strong background in business development, which will be important with the data this fall. We were also fortunate that Uli is ready to step in as chairman and Thomas von Koch is eager to join our board after his recent investment.
You will soon be taking over as CEO. What will be your top priorities for the remainder of the year?
– I am laser focused on preparing our potential business partners and shareholders for the upcoming EXPAND and RESOLVE results due in the second half of this year. This will be crucial for our path forward. I will also help the team develop our expanded preclinical pipeline.
– SynAct has an incredible opportunity ahead of it so we need to do everything possible to increase knowledge about the company in Sweden but also abroad. As I talked about at our CMD, our path forward is clear. We just need to focus and execute.
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.»I am laser focused on preparing our potential business partners and shareholders for the upcoming EXPAND and RESOLVE results due in the second half of this year. This will be crucial for our path forward.«
