OncoZenge submits application for PRIME status in the EU

Stockholm, Sweden, January 2nd 2024 – OncoZenge AB (publ), a leading biotechnology company developing BupiZenge™, an innovative, opioid-sparing treatment for oral pain, today confirms the submission of an application for PRIME (Priority Medicines) status with the European Medicines Agency (EMA).

The PRIME initiative offers early, proactive, and enhanced support to accelerate the evaluation of promising medicines, to reach patients faster. To be eligible for PRIME, medicines must target an unmet medical need and show potential benefits for patients based on clinical data. 

BupiZenge™ is OncoZenge’s novel approach to treating pain caused by oral mucositis, a severely debilitating condition of painful swelling and ulcerations of the mouth, and a very common side effect of cancer therapy. Current treatments are ineffective and may expose patients to unacceptable safety risks and side effects. Oral mucositis-related pain has severe negative consequences for patients’ physical and mental well-being and can result in interruptions to their cancer treatments and an inability to eat, drink and sleep. In consequence, ineffective pain management has adverse impacts to patient outcomes and quality of life.

There are currently no curative or preventive treatment options for oral mucositis in the EU. The fragmented standard of care for treating oral mucositis pain is ineffective and leaves a significant unmet medical need. Supported by Phase 1 and Phase 2 clinical trial results, BupiZenge™ has the potential to address this unmet need and provide an effective, safe and well-tolerated treatment option for a large number of patients. In addition, it could significantly reduce healthcare costs currently spent on poorly managed pain related to oral mucositis.

“The unmet need for a targeted, locally acting, non-opioid based treatment that is not associated with the risks of opioid-based drugs in this condition is significant. BupiZenge has true breakthrough potential to help affected persons and their families who are currently being denied adequate pain relief at an acceptable side effect profile. PRIME status would provide important regulatory support to accelerate making BupiZenge available for these patients”, says Christoph Nowak, Board Member of OncoZenge.

Dr Stephen Sonis, Distinguished Faculty at the Dana-Farber Cancer Institute and Professor of Oral Medicine at Harvard, and member of the Scientific Advisory Board of OncoZenge, adds “BupiZenge could offer substantial benefits compared to today’s “one-size fits all” standard of care in two ways: first, consistent with the concept of precision medicine, it is used specifically in those patients whose symptom progression warrants intervention, and the as-needed dosing can be tailored to individuals; second, it should prevent the onset of use and/or the intensity and duration of use of systemic opioid analgesia.”

“The PRIME program promises additional support and an efficient dialog with EMA on our plans for a clinical phase 3 program. A positive decision will accelerate our path to approval in the EU, which is a strategic priority. PRIME status will also significantly de-risk the project from the perspective of a strategic partner, given the explicit acknowledgement from regulatory authorities that our drug candidate meets important patient and thereby market needs”, Stian Kildal, CEO of OncoZenge, concludes.

EMA’s decision on OncoZenge’s PRIME status is expected by the end of February, 2024.

BupiZenge™ – Potential to be the leading treatment for oral pain.

For additional information, please contact:

Stian Kildal, CEO, mobile: +46 76 115 3797, e-mail: stian.kildal@oncozenge.se
Christoph Nowak, board member, mobile: +46 73 980 6535, e-mail: christoph.nowak@oncozenge.se
Certified Adviser
OncoZenge’s Certified Adviser is Carnegie Investment Bank AB (publ).
OncoZenge AB
Gustavslundsvägen 34, 167 51 Stockholm, Sweden
About OncoZenge
OncoZenge develops a novel, effective, safe and well-tolerated treatment for oral pain in conditions where currently available treatment options either do not achieve sufficient pain relief or are associated with significant side effects. BupiZenge™ is a new oral lozenge formulation of bupivacaine, an anaesthetic with decades of clinical experience. OncoZenge's lead indication is oral pain due to an inflammatory condition called oral mucositis that affects millions of patients receiving cancer treatment. Oral mucositis causes profound physical and psychological suffering, and is a large unmet medical need for an effective, opioid-sparing treatment option. BupiZenge™ has shown significantly better pain relief compared to standard of care in this indication in a Phase 2 trial.
OncoZenge is headquartered in Stockholm, Sweden, and its share is publicly traded on Nasdaq First North Growth Market under the ticker ONCOZ.