The company has entered into a collaboration with Professor Costantino Pitzalis, Versus Arthritis Professor of Rheumatology at the William Harvey Research Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London.
As a world leading expert in pathobiology, translational research and biopsy driven clinical trials, Professor Pitzalis brings invaluable expertise and know-how in rheumatoid arthritis (RA) clinical trial design and will be pivotal in Cyxone’s planned clinical trial in RA indication for the compound Rabeximod, states the company in a press release.
Professor Pitzalis’ research interests focus on the cellular and molecular mechanisms of inflammation and autoimmunity in chronic rheumatic conditions – particularly RA. Professor Pitzalis has been involved in the development of several recently approved RA therapies and is a leader in innovative clinical trial design. In 2020 he authored a review published in Nature Reviews Rheumatology entitled Transforming clinical trials in rheumatology towards patient-centric precision medicine.
“I am excited to enter into collaboration with Cyxone and look forward to advancing and expanding their unique therapeutic candidate Rabeximod, on track to enter Phase 2b clinical trials. The mode of action of Rabeximod is differentiated from current therapies and offers a route to functional modulation of macrophages, key cells in synovial pathology and RA pathogenesis by inhibiting the production of proinflammatory cytokines critical to drive disease and structural damage in the joint,” says Pitzalis “This mode of action in addition to its oral availability and safety profile make Rabeximod a potential ideal candidate for a first line treatment. There is a large unmet need, due to the significant potential side effects of Methotrexate, nausea, feeling unwell for 2-3 days post-dose that leads to poor compliance in many patients. If a drug is made available even with the same efficacy as Methotrexate but with a better safety/tolerability profile, it would fill a large unmet need. I look forward to working with the highly professional Cyxone management team and the associated team of world class advisors to unlock the full therapeutic potential of Rabeximod and address the unmet need of the sizable number of patients non-responsive to current medications.”
Include ex vivo studies to deepen the understanding of the mode of action
As part of the collaboration with Cyxone, Professor Pitzalis along with a team of world-class international rheumatologists has advised Cyxone on the updated Phase 2b trial design, bringing together competencies to cover a broad range of aspects in the field of rheumatology. The advisors have purposely fine-tuned and optimized the design of Cyxone’s next clinical Phase 2b study of Rabeximod, building on the encouraging results of the Phase 2a trial.
Within the scope of the collaboration Cyxone will seek to include ex vivo studies to deepen the understanding of the mode of action and potentially expand applicability to other disease indications. In addition, running the next trial in collaboration with Professor Pitzalis will provide Cyxone the opportunity to include biopsy driven endpoints to define the mode of action of Rabeximod on immune cells in the joint and provide key biomarkers as early predictors of therapeutic efficacy.