BioStock-artikel: Cyxone har avslutat rekryteringen i fas II-studien i covid-19

BioStock publicerade den 16 augusti 2021 en artikel om Cyxone, som återges nedan i sin helhet.

Det svenska bioteknikbolaget Cyxone meddelade under förra månaden att patientrekryteringen i deras fas II-studie med Rabeximod i covid-19 avslutas då man rekryterat ett tillräckligt antal patienter för att kunna genomföra en effektiv analys. BioStock kontaktade Cyxones vd Tara Heitner för att höra vad nyheten innebär.

Som BioStock kunde rapportera i slutet av förra året, såg det Malmöbaserade bioteknikbolaget Cyxone potentialen i att behandla covid-19-patienter med Rabeximod, Cyxones läkemedelskandidat mot ledgångsreumatism (RA). Bolaget planerade för en fas II-studie för att testa hypotesen för att kunna möta det brådskande medicinska behov som uppstått i och med pandemin.

Fas II-studien fullrekryterad
Studien inleddes i januari i år och bolagets ambition var att rekrytera 300 patienter. I juli meddelade Cyxone emellertid att cirka 90 patienter rekryterats och efter att ha granskat de statistiska villkoren för studien med hjälp av experter inom biostatistik, kom man fram till att underlaget var tillräckligt för att kunna utvärdera Rabeximods effekt jämfört med placebo. Studieresultaten kommer att presenteras under det tredje kvartalet 2021.

Trots den snabbt föränderliga miljön för patientrekrytering som rådde under våren 2021 hade Cyxone fram till juni framgångsrikt knutit till sig 21 kliniker i fem östeuropeiska länder och rekryterat 90 patienter – ett tecken på att bolaget var välförberedda att genomföra studien under de ovanliga förutsättningarna. Med delta-variantens snabba spridning över Europa och nya åtstramningar av restriktioner, ser den avslutade rekryteringen vältajmad ut.

Nuvarande behandlingar är inte tillräckliga
För närvarande saknar patienter med moderat till svår covid-19 en effektiv behandling. Antivirala läkemedel som exempelvis Gilead Sciences Remdesivir har godkänts av FDA, men effektiviteten är fortfarande låg. Uppkomsten av nya och mer smittsamma varianter äventyrar vaccinationskampanjerna, liksom svårigheten att distribuera och säkerställa en utbredd vaccinering. Behovet av behandlingar som förebygger allvarlig sjukdom är fortfarande stort.

En av de vanligaste komplikationerna som drabbar covid-19-patienter med moderat till svår sjukdom är akut andnödssyndrom (ARDS), en typ av andningssvikt som kännetecknas av en snabbt utbredd inflammation i lungorna, en s.k. cytokinstorm. Eftersom flera av mekanismerna i RA återfinns i ARDS, tror Cyxone att Rabeximod har stor potential i covid-19-patienter.

Vd kommenterar
BioStock kontaktade Cyxones vd Tara Heitner för att fråga om betydelsen av att ha nått en fullt rekryterad studie och hur Rabeximod kan jämföras med andra covid-19-behandlingar.

Tara, this phase II trial with Rabeximod in Covid-19 patients had originally planned for 300 patients. Will 90 patients be enough for accurate data analysis?

– We originally designed the trial based on assumptions around clinical effect stemming from what little was known about Covid-19 trials in the early phase of the pandemic. Many Covid-19 trials have been run since then and we can build on this experience. Based on the current knowledge we chose to perform a reassessment of the statistical foundations for the trial and have concluded that the approximately 90 patients that have been enrolled in the study constitute a sufficient number to conclude the study.

– In retrospect, knowing what we know now, it was quite ambitious to try to recruit 300 patients on only 6 months. I am actually, quite pleased that we managed to recruit 92 patients in all at an average of 15 patients per month. It is a very fine achievement especially given the difficult and often dire conditions during the pandemic. We will now get the opportunity to learn more about the potential for Rabeximod in this complicated disease indication and stick to our original timelines.

What are the overall implications of this decision to close patient recruitment, in your view?

– A major implication is that with the new statistical assessment, we will get results from the study and thus understand the efficacy of Rabeximod in Covid-19 patients by end of Q3 as planned and so remain on schedule and within a smaller budget. Armed with this data we will be able to meet with the regulatory authorities to discuss top line results which will determine how best to move forward with the program.

– Another implication is that we do not need to take on additional risk and allocate additional resources to complete the trial while being able to complete the phase 2 assessment under budget.

– One learning that we will build on as an organisation is the experience gained from running a clinical study in a disease indication characterised by high complexity and constantly changing requirements. This makes us much better prepared for the upcoming clinical programs in RA and MS.

Did the rise of Delta variant cases influence this decision in any way?

– The rise of the Delta variant emphasises the continued need for further development of drugs in the covid space. We hear patients that have been vaccinated are contracting the disease and can spread the disease especially to the unvaccinated. Many people remain unvaccinated even when the vaccine is easily accessible. The healthcare systems therefore need to have tools at hand to treat new patients with Covid-19 and prevent progression to severe disease and hospitalization.

Why does Rabeximod have such high potential in Covid-19 patients, and how does it compare with antivirals like Remdesivir, for example?

– We see a potential for Rabeximod to prevent cytokine release syndrome that is seen as a consequence of Covid-19, leading to severe disease and hospitalisation. Rabeximod has been proven to have an impact on the mechanisms that lead to release of the cytokine molecules which drive inflammation in Covid-19. These mechanisms are also central to the disease pathology in RA.

– In contrast to Remdesivir which functions by impacting on the virus particle itself, Rabeximod affects the exaggerated inflammatory response that the virus infection give rise to, and which is the cause of the severe symptoms of Covid-19.

Finally, could you address the challenges of vaccine distribution and efficacy and why Covid treatments will still have their place on the market?

– The experiences of the past year underscore that even though the pharmaceutical industry has done a phenomenal job in developing effective vaccines in record time, science in not enough to stop the pandemic. Advanced production and distribution strategies that are equitable and not focused only on developed countries are required.

– Many wealthy countries are currently vaccinating children while the majority of adults in developing regions remain unvaccinated. There needs to be political will to educate and distribute, and society also needs to accept to take the vaccine. The latter requires education and may apparently take time. Time that the virus and its variants are not giving us.

– Therefore, effective treatments that can be efficiently produced and distributed to prevent severe disease are still urgently needed and unfortunately will be needed for some time to come.

Läs artikeln på BioStocks webbsida

Innehållet i BioStocks nyheter och analyser är oberoende men BioStocks verksamhet är i viss mån finansierad av bolag i branschen. Detta inlägg avser ett bolag som BioStock erhållit finansiering från.