March 20, 2024
Being very pleased and grateful for the overwhelming support given by our shareholders to the EGM decisions on 20 March 2024, it is a highly motivated team that is ready for taking on the challenge of getting the company back on track and resomelagon (AP 1189) into clinical phase llb development.
We look forward to working with the new board of directors to ensure that we meet the important milestones lying ahead of us and continuing interactions with potential takers awaiting phase llb data in 2025.
Despite all the therapies available to treat rheumatoid arthritis, many patients still have ongoing disease activity and require additional efficacy. A once daily oral and well tolerated therapy like resomelagon that works by a non-immunosuppressive mode of action – inflammation resolution – could positively impact the lives of many patients dealing with the challenges of rheumatoid arthritis and other inflammatory diseases.
Data from the BEGIN study and the patients in the EXPAND study who at time of recruitment were newly diagnosed with sign of systemic inflammation strongly support continued development of the compound in RA. The current RA treatment guidelines support early intervention with the aim to control disease activity as fast as possible. The conventional disease modulating anti-rheumatic drug (cDMARD) methotrexate (MTX) is the cornerstone first line treatment option, often in combination with glucocorticoid (GC) treatment. A treatment approach that despite slow onset of action and risk for unwanted side effect of MTX treatment and unwanted side effects of the GC treatment seems as effective and better tolerated that treatment with the more expensive biologic DMARDs (bDMARD). However, there is a clear room for improvement. Many patients will need additional treatment with second line compound as the bDMARDs and many patients will end in a setting where the GC treatment will be continued in a more chronic fashion that is highly unwanted having the side effect profile of the GCs in mind.
We strongly believe that resomelagon applied early as an add on the current treatment approach in RA could reduce the use of GC and delay or in the best case avoid the need to add second line treatment with bDMARD. The intention of our continued clinical development of resomelagon in RA is to further evaluate this approach which could be a break thought for resolution therapy in RA and other autoimmune and inflammatory diseases.
We will also explore the potential of resomelagon in more advanced RA. The intention of the RESOLVE study was to test the potential of the compound in DMARD-IR patients, ie in patients who failed to response adequately to MTX (and GCs). In the RESOLVE part A, we recruited a very heterogeneous patient population. This was not different from many other studies aimed to test the potential of a drug in DMARD-IR patients. However, having the compound’s mode of action in mind, it was most likely not be best way of testing the compound. To continue the development in the DMARD-IR patients should therefore be done in a very controlled fashion. The possibilities to do that will be explored and we will as soon as we have initiated the continued development in first line treatment, return with our plans aimed to further exploit this possibility.
Resomelagon also has the potential to modulate hyperinflammation in virus infections as shown in the RESOVIR study. We intend to continue to our scientific engagement in the RESOVIR (Resolution in Viral Infection) collaboration and will return with news from this collaboration in the coming weeks and months. Ideally additional clinical trials should be setup, but until we are back in a more stable setting we will focus on the preclinical activities and explore the potential of new clinical activities.
We will also readdress the potential of the compound in the kidney space where recruitment to our study in idiopathic membranous nephrology patients with severe proteinuria/nephrotic syndrome despite a high level of enthusiasm from our investigators has been a challenge.
Our peptide project focused on the TXP peptides needs more focus. We had to reduce the activities in 2023 due to lack of financing. However a number of experiments have been initiated and we will report those as soon as we get the final results. If the data support the potential of the compounds, it would, pending funding, be possible to take the TXP-11 compound in clinical development in 2025.
In order to develop the full potential of our pipeline we would need funding to a level that hardly would be realistic with the current share price in mind. We will therefore secure new funding stepwise. The first step is aimed to secure funding to continue development of resomelagon in RA and additional pharmacological activities as mentioned above. Initiation of further clinical activities will have to await the next steps.
An integrated part of this strategy will be to secure a lean cost structure. We are convinced that a small first step financing round can be completed on attractive terms for the company and for our many shareholders.
The current situation is of course challenging, but we are greatly encouraged by the opinions and support from our key opinion leader advisors. This taken together with our belief in resomelagon is already being leveraged to help investors see the same potential we do.
We sincerely appreciate the investment and continued support of our shareholders who we know are committed with us to unlock the potential of resolution therapy.
We have excellent opportunities ahead of us, and we remain focused on delivering patient, company and shareholder value. The new board of Synact Pharma comprises expert knowledge and valuable experience in drug development and capital markets, as well as the building and governance of biotech and pharma companies and the four members will be able to work in an agile setting to ensure that milestones are met and programs are moved forward.
Jeppe Øvlesen | CEO and Board Member