Beskrivning
| Land | Sverige |
|---|---|
| Lista | First North Stockholm |
| Sektor | Hälsovård |
| Industri | Bioteknik |
OncoZenge AB (publ) ("OncoZenge" or "the Company") today announces that LINK Medical has been engaged to conduct a feasibility study in Europe for the Company's planned Phase 3 study for European approval of BupiZenge™.
OncoZenge is planning a multi-country Phase 3 study for the approval of BupiZenge™ in Europe. The scope of the Phase 3 study has been updated in recent weeks in close collaboration with the Company's licensing partner, Molteni Farmaceutici. As part of the planning and to optimize lead-times, the Company has engaged LINK Medical to perform a feasibility study for the European part of the study.
The study aims to confirm the availability of suitable sites in Europe, with a focus on Germany, Denmark, Norway, and Sweden. The study will also provide important validation of the expected patient recruitment rate and, consequently, the overall timeline.
"We are very pleased to collaborate with OncoZenge in this feasibility study. At LINK Medical, we specialize in guiding Nordic biotech companies through the complex clinical landscape in Europe. This partnership reflects our commitment to providing practical expertise, local insights, and seamless execution to help our clients succeed in every development phase." - Anders Göransson, CEO LINK Medical.
"The availability and selection of study sites in Europe is a critical issue that lies on the critical path of the timeline for our Phase 3 program. Obtaining decision-making data on this during the summer will thus save valuable time later. LINK Medical has made a very positive impression, and we look forward to a successful collaboration towards our goal of initiating the full Phase 3 project for BupiZenge," says Stian Kildal, CEO of OncoZenge.
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
Certified Adviser
OncoZenge's Certified Adviser is Redeye AB.
OncoZenge AB
Gustavslundsvägen 34, 167 51 Stockholm, Sweden
About this release
The information in this release was submitted for publication, through the agency of the contact persons set out above, at 15:00 CEST on June 3, 2025.
About OncoZenge
OncoZenge is dedicated to developing an innovative, effective, and well-tolerated treatment for oral pain in conditions where current options fall short, often due to insufficient pain relief or significant side effects. BupiZenge™ is a novel oral lozenge formulation of bupivacaine, a local anesthetic with decades of clinical experience. The lead indication for BupiZenge™ is oral pain caused by oral mucositis, an inflammatory condition affecting millions of cancer patients. Oral mucositis leads to severe physical and psychological distress, representing a significant unmet medical need for an effective, opioid-sparing treatment. In Phase 2 trials, BupiZenge™ demonstrated substantially better pain relief compared to the standard of care.
OncoZenge is headquartered in Stockholm, Sweden, and is publicly traded on Nasdaq First North Growth Market under the ticker ONCOZ.