SynAct Pharma uppnådde nyligen en milstolpe genom att slutföra doseringen i fas IIb-studien EXPAND för resomelagon (AP1189), deras kandidat riktad mot reumatoid artrit. Dessutom har bolaget nu framgångsrikt rekryterat samtliga patienter till del A i fas IIa/b-studien RESOLVE. För att få veta mer om denna utveckling kontaktade BioStock SynAct Pharmas vd, Torbjørn Bjerke, för en kommentar.

Bioteknikföretaget SynAct Pharma är specialiserade på inflammatoriska sjukdomar och dedikerade till att utveckla en ny behandlingsmetod som fokuserar på att stimulera upplösningen av inflammation. I centrum för dessa strävanden står utvecklingen av huvudkandidaten resomelagon (AP1189). Kandidaten har visat lovande potential för att främja inflammatorisk upplösning genom att selektivt aktivera melanokortinreceptorer 1 och 3, vilka båda utlöser kroppens naturliga inflammatoriska upplösningsmekanismer.

Två pågående kliniska studier i RA

Resomelagon utvärderas för närvarande i tre pågående kliniska prövningar, varav två är specifikt inriktade på den försvagande autoimmuna sjukdomen reumatoid artrit (RA).

Det utmärkande kännetecknet för denna kandidat ligger i dess selektiva stimulering av melanokortinreceptorer, vilket gör det möjligt att effektivt utöva antiinflammatoriska och immunupplösande effekter. Detta tillvägagångssätt syftar till att kringgå de typiska säkerhetsproblemen, tolerabilitetsproblem och de biverkningar som ofta är förknippade med adrenokortikotropa hormonbehandlingar (ACTH).

I takt med att forskningen fortskrider är SynActs förhoppning att resomelagon ska bana väg för ett välbehövligt genombrott för behandling av RA och för att förbättra patienternas behandlingsresultat och livskvalitet.

Slutförd dosering i EXPAND-studien

EXPAND-studien bygger på fas IIa RA-studien BEGIN där resomelagon minskade patientens sjukdomsaktivitet jämfört med placebo genom 4 veckors behandling. I både BEGIN- och EXPAND-studierna ges resomelagon i kombination med första linjens behandling metotrexat till patienter som inte genomgått RA-behandling tidigare.

Tidigare denna månad meddelade SynAct att doseringen hade slutförts i bolagets 12-veckors kliniska fas IIb-studie som utvärderade resomelagon med dosering en gång dagligen hos patienter med tidig reumatoid artrit med svår sjukdom. SynAct räknar med att kunna publicera top-line studiedata i september.

Patientrekrytering slutförd i RESOLVE-studien

RESOLVE är en fas IIa/b-studie av resomelagon i patienter som upplever måttlig till svår sjukdomsaktivitet och har ett otillräckligt svar på första linjens sjukdomsmodifierande antireumatiska läkemedel (DMARD-IR).

Studien är uppdelad i två delar, A och B, och igår meddelade SynAct att patientrekryteringen till del A av fas IIa/b-studien är avslutad. Bolaget räknar med att släppa top-line studiedata i oktober i år.

»The attractive market position we believe that resomelagon can achieve in RA exists in many other inflammatory conditions where first-line therapies are inadequate for many patients« – Torbjørn Bjerke, vd SynAct Pharma

Vd kommenterar

BioStock kontaktade Torbjørn Bjerke, vd för SynAct Pharma, för en kommentar kring de senaste framstegen.

First, before we get into the trial updates, what are your views on how resomelagon differs from existing treatments for rheumatoid arthritis, and what advantages you think it may offer to patients?

– The last few decades have witnessed amazing advancements in treating autoimmune diseases like rheumatoid arthritis or RA with an anti-inflammatory strategy. While these therapies have been game changers, there is still between 50-70% of the patients that do not experience a relief of their symptoms. In addition, the current treatments have also demonstrated the risks that can come with suppressing the immune system. With resomelagon, we seek to go beyond suppression by stimulating the body to resolve inflammation. The efficacy and safety challenges with key classes of RA therapeutics clearly shows the tremendous need for new treatments with improved risk benefit profiles.

SynAct has now completed dosing in the EXPAND study – why are you targeting this newly diagnosed severe activity population?

– We are excited that the phase IIb EXPAND study of resomelagon or AP1189 in rheumatoid arthritis is fully recruited and has completed dosing with top-line results expected in September. The team is optimistic the data will continue to show the benefit of treating newly diagnosed severely active RA patients with resomelagon (AP1189). Severe disease activity is the recognized key indicator of a potential poor course of disease and these patients need to have their symptomology quickly and safely resolved.  Currently, these patients are treated with traditional DMARD therapies like methotrexate which can be insufficient in these patients presenting with severe disease activity.

Patient recruitment for part A of the RESOLVE study is now complete – why are you investigating resomelagon in this study focusing on inadequate response to first-line disease modifying anti- rheumatic drugs (DMARD-IR)?

– RESOLVE, which had 125 patients randomized into the study, is progressing ahead of schedule with top-line data in October, setting the stage for starting the 12-week phase IIb portion of the RESOLVE study in the first half of 2024. There is clearly a need for an efficacious and safe oral treatment option for DMARD-IR patients as these patients suffer from uncontrolled disease despite being treated with first-line agents. Rheumatologists in market research we have commissioned, state that approximately 50% of the patients they start on DMARDs do not have an adequate initial response and another 20% or so who have a good initial response will lose that response within 1 year.

– Current options for these patients are starting injectable biologic therapy likely with an anti-TNF agent or outside of the US with JAK inhibitors. Both of these options expose the patients to added risks of immunosuppression. The JAK inhibitors used to be available for these patients in the US but the FDA moved these therapies to after anti-TNFs due to their significant safety concerns.

With these two main studies set to show data, what options could SynAct have regarding future development?

– SynAct is in a strong position. We continuously have discussions with potential partners in the inflammation space, and we are constantly working to attract like-minded institutional investors who could help us execute on our strategy. We feel that RA, in addition to being a good disease target, is also a proof of concept for resomelagon in chronic autoimmune or inflammatory diseases. The attractive market position we believe that resomelagon can achieve in RA exists in many other inflammatory conditions where first-line therapies are inadequate for many patients.

– It is obvious there is a large amount of international interest in the inflammation space, and we are confident SynAct’s resomelagon (AP1189) has an important role to play in treating RA and potentially other indications going forward. We are looking for partners and investors who see the broad potential for resolution therapy who will help us develop resomelagon in and beyond RA into other key inflammatory conditions. It is an exciting time for the company and our shareholders as we begin to deliver on the promise of resomelagon and resolution therapy.

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