October 12 is World Arthritis Day, which every year draws attention to people living with arthritic diseases. This term refers to a number of diseases and conditions that attack joints, bones, tissue and muscles. The most common inflammatory rheumatic disease is rheumatoid arthritis – where there is a great need for new disease-modifying treatments. The biotech companies Lipum, Cyxone and SynAct Pharma are all listed in Sweden and have as their main focus to develop new treatments for rheumatoid arthritis. BioStock summarises the latest from these companies that give hope for the future.
Rheumatism is a collective name for about 200 different diseases and conditions that attack the bones, joints and muscles, but also blood vessels, connective tissue and the heart. The diseases affect people of all ages and in Europe about 120 million people live with a rheumatic and muscoloskeletal disease.
Every year October 12 is World Arthritic Day, a day when the life situation of arthritis patients is given extra attention. Issues in focus include the shrinking workforce in healthcare, the long waiting times for a doctor’s appointment and the general lack of understanding among decision-makers of how arthritic diseases affect those living with them.
Great need for new RA treatments
Another issue in constant focus is the development of new disease-modifying treatments, so-called DMARD (Disease Modifying Anti-Rheumatic Drugs). In such a broad area as arthritic diseases, there is no one-size-fits-all solution – however, intensive development work is underway in many of the indications.
The most common inflammatory rheumatic disease is rheumatoid arthritis (RA). About one per cent of the world’s population lives with the disease, which also affects twice as many women as men.
For a long time, many RA patients have been treated with the drug methotrexate, but a large percentage of patients do not respond adequately to the treatment. Many patients are prescribed symptom-relieving treatments or biological drugs.
Biological drugs are often effective but can cause side effects that put the patient’s safety at risk. A current example are the JAK inhibitors, a new class of oral drugs, for which the US Food and Drug Administration (FDA) has issued a so-called black box warning due to the serious side effects that can occur. Learn more.
Three treatments in clinical development
There is ongoing development of new RA treatments, examples of three companies conducting clinical development are Umeå-based Lipum, main-listed SynAct Pharma and Malmö-based Cyxone.
Lipum has developed an antibody that blocks Bile Salt-Stimulated Lipase (BSSL), a previously overlooked target molecule in the immune system. In the autumn of 2022, the company will begin the first clinical studies in humans with its candidate SOL-116. In the upcoming phase I study, the primary goals are to establish safety and tolerability in healthy subjects. However, inflammatory biomarkers will also be observed, and the study will also include a patient group with RA patients. Watch BioStock’s interview from September with CEO Einar Pontén here.
Phase IIb for Cyxone and Synact Pharma
Cyxone is developing the drug candidate Rabeximod as a new oral and well-tolerated treatment for RA in both early and later stages of the disease. With a new mechanism of action, the candidate targets macrophages that play a central role in the tissue-degrading inflammatory process.
Recently, the company was approved to start its phase IIb study in Poland, the study will also be expanded with clinics in countries such as Hungary and Georgia.
SynAct Pharma, which is listed on Nasdaq Stockholm’s main list since July this year, is in proof-of-concept studies with its lead candidate AP1189. The aim of the candidate is to promote resolution of inflammation without inhibiting the immune system.
In November 2021, the company announced positive results from a phase IIa study in newly diagnosed and previously untreated RA patients with severe disease activity. During the summer, the company submitted a Clinical Trial Application to advance the candidate to a phase IIb study. The application is approved in Moldovia and Bulgaria and the first patient was recruited late September.
At the end of September, SynAct also submitted an IND in the US to start a phase IIa/b study with AP1189 in DMARD-IR patients, i.e. patients who have not achieved the desired effect with DMARD. Learn more.
Daily attention from the stock market
Many steps remain for the above companies before they can offer patients a new RA treatment. The development work is priced daily via the listings on First North and Nasdaq’s main list. In 2022, none of the shares has performed well, Lipum has fallen 17 per cent so far this year, Cyxone by 59 per cent and SynAct 65 per cent – which is in line with many companies in the sector that have conducted financing rounds for the next clinical step. Cyxone and SynAct raised capital earlier in the year and Lipum carried out a directed share issue in September.
For a successful candidate, there is a significant potential within a large patient group that demands new treatments. After all, clinical results are the major value driver for biotech companies.
However, World Arthritis Day draws attention to issues that cannot be quantified in a share price, but which require debate and reactions that can be as significant for patients as a new drug.