In the preparation for the coming phase IIb trial with Rabeximod in rheumatoid arthritis, biotech company Cyxone has entered an Early Operations Agreement with an internationally renowned clinical contract research organisation. BioStock contacted CEO Tara Heitner to learn more.
Malmö-based Cyxone develops disease modifying therapies for rheumatoid arthritis (RA), multiple sclerosis and virally induced acute respiratory disorders.
Agreement with a clinical CRO
In line with previously communicated timelines Cyxone has initiated preparatory activities for an upcoming phase IIb trial with drug candidate Rabeximod in RA. To prepare for enrolling patients in 2022, Cyxone has entered an early operations agreement (EOA) with a clinical contract research organisation (CRO) who will be involved in finalisation of the study protocol and the selection of countries, sites and investigators for the trial as part of the agreement.
The CRO is an internationally renowned organisation with a proven record of planning, conducting and collecting data in clinical trials and extensive experience in RA.
The trial will be randomised, double-blinded, with three treatment arms evaluating two dose levels of Rabeximod together with standard of care methotrexate compared to methotrexate alone during a treatment period of 16 weeks. The patient recruitment will be expected to run over 12-18 months.
The CEO comments
BioStock reached out to Cyxone’s CEO Tara Heitner to learn more about the agreement and the ongoing preparations, and also for a comment on the latest patent news.
Tara, to begin with, can you briefly explain why Rabeximod is a suitable candidate in RA?
– First of all despite the many therapeutics available for RA, there are still many patients that do not respond or respond poorly to medication. Others suffer side effects that become burdensome. So new innovative therapies are required for RA, especially alternative first line treatments.
– Rabeximod is unique in that it suppresses the immune cell population that is directly responsible for the damage to the joint in RA so Rabeximod has the potential to provide disease modifying efficacy via a novel mode of action.
– Since no other drug in development or on the market has this mode of action, we hope to offer RA patients a novel alternative to current standard of care for those patients who are underserved.
– Rabeximod has been shown to be well tolerated in early clinical trials, and is administered as an oral capsule, thus being an attractive alternative to injectables. Our vision is to develop an oral drug that provides disease modifying benefits without the burden of tolerability issues and side effects.
What data do you have to support this hypothesis, so far?
– Wehave a comprehensiva pre-clinical data package that supports the mode of action on the suppression of the immune cell responsible for joint damage in RA. Furthermore, human data from our phase I and phase II studies support the favourable safety and tolerability profile, and our phase IIa study demonstrated efficacy in a severe RA population with well established RA.
– Based on these data the objective of the study is to assess safety and tolerability and to confirm effectiveness of Rabeximod at week 16 and potentially demonstrate even greater effectiveness in an early diagnosed and more homogeneous RA patient population.)
Cyxone recently announced that a new patent application for Rabeximod has been filed. Can you comment on what this means for the RA program?
– A new patent which covers new forms of Rabeximod will provide Cyxone with a new composition of matter patent protection if awarded. In combination with the four other patent applications which were filed in 2020 the new patent strengthens our patent position in RA and across other indications.
– Furthermore, the new patent estate may secure patent protection until 2043 and beyond.
– Rabeximod is an important value driver for Cyxone and this potential extended patent protection increases the value even more, while giving the company more flexibility to exploit Rabeximod in RA and in additional indications. As a multi-indication asset Rabeximod can deliver therapies for several indications and greater value to our investors.
You have now entered an EOA with a CRO, what does this mean for the project?
– The EOA indicates a formal commitment to study initiation and to the early activities needed to ensure we can enroll patients into our study as early as possible in 2022.
– The agreement shows that we are on track with our previously communicated timelines to start study activities in Q4 2021 and that we have a highly qualified CRO on board with a superior track record in RA.
Where will the trial take place?
– The EOA will help us to narrow down the countries where the study will be feasible however at this time we are focusing on strategic countries and sites in Europe and USA.
What are the next steps that are required?
– Initiating a clinical trial require a lot of preparation and there are many things to put in place. This agreement will allow a lot of the requirements from the regulatory authorities and by the CRO to be put in place in time.
When do you expect the trial to start?
– We aim to start enrolment as soon as possible in 2022 following regulatory approvals.
Finally, when will you be able to present the first results from the trial?
– We estimate 12-18 months to recruit all patients into the trial (approximately 250) and the last patient out would be 6 months following recruitment. Top line data would be available within 18-24 months of trial start.
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