4873 English

Bioteknikbolaget Cyxone meddelade nyligen en uppdaterad plan för utvecklingen av sin läkemedelskandidat Rabeximod. De fyra nya patentansökningar som skickades in tidigare i år kommer att bidra till en avsevärd förlängning av den potentiella marknadsexklusiviteten. Det har lett till en översyn av Rabeximods utvecklingsplan. Ansökningarna har lett till en signifikant värdeökning för Rabeximod. Covid-19-pandemin pågår med ett omedelbart och oförminskat behov av bättre behandlingar, ett område där Cyxone hoppas kunna göra skillnad med Rabeximod. Cyxone avser att inleda en studie med Rabeximod i Covid-19-patienter med möjlig start under fjärde kvartalet 2020.

First North-noterade Cyxone utvecklar immunmodulerande läkemedel mot autoimmuna sjukdomar och andra störningar i immunförsvaret. I den kliniska utvecklingsportföljen ingår Rabeximod mot ledgångsreumatism (RA) och T20K mot multipel skleros.

Bolaget meddelade nyligen att man uppdaterat planen för utvecklingen av fas II-kandidaten Rabeximod, som man även avser att pröva som en potentiell behandling av moderata Covid-19-patienter för att förhindra allvarlig andningssvikt (ARDS).

Det kliniska fas II-programmet i RA håller på att optimeras och MS-programmet avancerar också – en andra fas I-studie planeras med kandidaten.

En uppdaterad plan för Rabeximod

Cyxone lämnade in fyra patentansökningar i juni som ska ge ett längre och uppdaterat IP-skydd för Rabeximod. De nya patenten kan innebära en förlängning av skyddet fram till 2043. Det förlängda patentskyddet ger Cyxone möjlighet utöka värdet genom att positionera kandidaten optimalt på RA-marknaden.

Optimeringen av Rabeximods utvecklingsstrategi baseras på resultaten från tidigare prekliniska och kliniska studier, uppdaterad marknadsanalys, samt råd från bolagets vetenskapliga rådgivare och andra experter. Läs BioStocks intervju med de nya rådgivarna här.

Avsikten med analysarbetet är att förbättra det ouppfyllda medicinska behovet via Rabeximods unika egenskap att rikta sig mot inflammatoriska makrofager.

»Rabeximod has the opportunity to make a difference for Covid-19 patients by providing access to a drug that can be taken conveniently as a pill, is well tolerated and has a favorable safety profile, and that acts on the central component of the disease.« – Tara Heitner, vd Cyxone.

Covid-19 – ett nytt indikationsområde

ARDS är ett akut tillstånd som kan uppstå som en följd av en överreaktion immunsystemet hos Covid-19-patienter. Cyxone vill pröva Rabeximods förmåga att dämpa denna immunreaktion i moderata Covid-19-patienter och förhindra progression till ARDS.

Bolaget förbereder nu en ansökan om att starta en fas II-studie i Europa i år. Givet ett snabbt myndighetsgodkännande, kan Cyxone inleda studien under fjärde kvartalet. Studien är planerad att omfatta 300 patienter och bolaget förväntar sig att kunna presentera topline-resultat under tredje kvartalet 2021. Bolaget utreder för närvarande projektets kommersiella möjligheter och partnering-värde vid fas II-studiens fullbordande.

Vd kommenterar

BioStock kontaktade vd Tara Heitner för att få en kommentar om de uppdaterade Rabeximod-planerna.

Tara, you have been updating the development plan of Rabeximod, how can this news be interpreted?

– The extended patent protection has made it possible for us to include Covid-19 as a potential indication for Rabeximod, and given the global pandemic we quickly decided this was necessary to investigate immediately.

– This means that we will be able to initiate a phase II study earlier than expected, potentially in the fourth quarter this year. Rabeximod has the opportunity to make a difference for Covid-19 patients by providing access to a drug that can be taken conveniently as a pill, is well tolerated and has a favorable safety profile, and that acts on the central component of the disease.

– Acute patients are at greater risk of death and put an undue burden on health care systems, therefore we are targeting moderate patients with the aim to prevent progression to the acute stage and relieve the burden on health care systems. The tolerability and safety profile of Rabeximod as well as its ease of oral administration make it a suitable option for moderate Covid-19 patients.

– As we have outlined above, we are taking the time to look into the unique features of Rabeximod, the evolving market landscape and to discuss with experts in the area. We are now evaluating in detail how to develop Rabeximod and bring the most benefit to patients suffering from RA.

How is the mode of action related to your revised plans in RA?

Tara Heitner, CEO Cyxone

– Rabeximod targets macrophages – the main orchestrator of the inflammatory process and this is relevant both in RA and Covid-19 but in different ways. There are of course also important differences between the RA and Covid-19 indications as the former is a chronic illness with periods of flares and remission and the latter can develop to a severe acute condition. We believe the unique mechanism of action is relevant in both indications as the macrophage is central in both.

One of the reasons for the revised plan was a new market landscape, can you tell us more what you mean by that?

– Both the market landscape for treatments and the standard of care in rheumatoid arthritis have changed since the previous phase II study was performed with Rabeximod. With that I am referring to orally administered JAK inhibitors, the increased availability of drugs in both subcutaneous and intravenous formulations, the entry of drugs with novel mechanisms of action and the launch of biosimilars.

– There is a more crowded competitive landscape and the bar for showing efficacy has changed. However, our Scientific Advisory Board and Key Opinion Leaders say the market is still demanding safe effective drugs which can prevent the progression of the disease and the damage to the joints which occurs in RA. We understand the benefit, convenience and safety profile of Rabeximod is favorable within this landscape.

Covid-19 has been added as a new indication, what are your expectations on this project?

– If allowed to progress, patients affected with Covid-19 face a risk of severe respiratory failure, caused by an overreaction of the immune system. Rabeximod can potentially halt this progression as it inhibits the release of multiple cytokines by selectively modulating the hyper activated macrophage without suppressing the entire immune system, which is an important safety advantage

– Inhibition of multiple cytokines rather than single cytokines such as IL-6 may be important for efficacy in Covid-19. The idea is to treat Covid-19 patients with Rabeximod in a moderate phase of the disease, to prevent progression to a critical stage and avoid requirement for intensive care treatment.

– If the outcome of the trial is successful, we could have a safe treatment for patients with moderate Covid-19 infections, preventing them from advancing to the acute stage which would relieve the heavy burden that acute patients put on health care systems and save patients from painful and lethal conditions.

Finally, how will the trial be financed?

– The Covid-19 trial will mostly be financed by the directed share issue to Dr Kalev Kask according to the agreement we entered with him in June. In that agreement we negotiated this investment option as part of payment to Dr Kask for acquiring the exclusive rights to a new patent application around Covid-19 for which he is the inventor. This patent application is considered to be instrumental for building value in our joint project to develop a new treatment for Covid-19.

– The activities for our other drug projects will hence not be affected by this trial. Importantly due to this financing our other R&D activities can continue in parallel.

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.

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