Partner article: Building sponsor oversight for a pivotal Phase III program

- A collaborative journey

OncoZenge is preparing to initiate a pivotal Phase III study for BupiZenge™, a treatment for oral mucositis pain in cancer patients. As the program advances into this critical stage, a central success factor has been the structured development of a strong sponsor oversight model, built through close collaboration with selected expert partners.

Oral mucositis is a common and debilitating side effect of cancer therapy, where current treatment options are often insufficient. BupiZenge™ has been developed to provide rapid and longer-lasting local pain relief, addressing a significant unmet medical need.

Following CTA approval, OncoZenge is now preparing to initiate its pivotal Phase III study in Europe. The trial will evaluate BupiZenge™ versus lidocaine in head and neck cancer patients experiencing oral mucositis pain. Approximately 150 patients are planned to be enrolled across sites in Sweden, Norway, Denmark and Germany, with first patient enrolment expected in Q2 2026.

The complexity of this study, spanning multiple countries, sites and functional areas. places high demands on coordination, quality and regulatory compliance. As such, establishing a robust and flexible sponsor oversight framework has been a key priority leading up to trial initiation.

Building sponsor oversight through collaboration

To meet these demands, OncoZenge has built its sponsor oversight capabilities through a combination of internal leadership and targeted external expertise. PharmaRelations has played a central role in this set-up, contributing senior consultants across program management, regulatory affairs, biostatistics, medical writing, quality assurance, and audit support.

This model has enabled OncoZenge to maintain strategic control of the program while accessing specialized expertise as needed, creating a flexible yet well-coordinated operating structure.

“Our collaboration with PharmaRelations has been important in building the sponsor oversight capabilities needed for Phase III. With CTA approval now secured, we are entering the next stage with strong support across several key functions,”
– Stian Kildal, CEO of OncoZenge

A coordinated journey toward CTA approval

The foundation for this Phase III program has been built over several years through close collaboration between OncoZenge and PharmaRelations. Throughout this period, the focus has been on establishing a sponsor oversight model that integrates internal decision-making with external expert support.

Anna Asplind, Phase III Program Manager within the OncoZenge program and senior consultant at PharmaRelations, has played a key role in coordinating activities across functions and partners, ensuring alignment, continuity and progress throughout the program.

“I have really enjoyed acting as the coordinating link between OncoZenge and our external partners. Together with strong support from Stian and the core team, it has been a very rewarding journey with many valuable discussions and learning experiences. Reaching CTA approval and now moving into the next phase is truly exciting,”
– Anna Asplind, Phase III Program Manager

PharmaRelations has contributed expertise in regulatory strategy, medical writing, biostatistics, QA GCP, and long-term QA GMP support. These competencies have been integrated into the program as needed, enabling a scalable and quality-driven approach to sponsor oversight.

A key element of the collaboration has been the close interaction between OncoZenge’s internal team and its external partners—ensuring that knowledge, accountability and decision-making remain aligned throughout the program.

A partnership-driven milestone

From PharmaRelations’ perspective, the collaboration highlights the value of long-term partnerships and embedded expertise in complex clinical development programs.

“Following OncoZenge’s journey over several years and seeing our team contribute so concretely to reaching CTA approval has been incredibly rewarding. It is a significant milestone for the program and an important step toward potentially making a real difference for patients,”
–  Emma Perlhamre, Nordic Head of Clinical Development at PharmaRelations

Looking ahead to Phase III

With CTA approval secured, OncoZenge is now entering the next phase of its development journey. Supported by an established sponsor oversight framework and a collaborative operating model, the company is well positioned to initiate and execute its Phase III study.

This foundation will be critical in ensuring high-quality study conduct, reliable data and ultimately supporting future regulatory submissions—bringing BupiZenge™ one step closer to patients in need.

Read the pressrelease about the approval here

Contact:
OncoZenge
Stian Kildal, CEO
+46 76 115 3797 | stian.kildal@oncozenge.se
https://oncozenge.se/
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PharmaRelations
Emma Perlhamre, Nordic Head of Clinical Development
+46 70 165 22 32 | emma.perlhamre@pharmarelations.se