OncoZenge can today confirm that comprehensive analyses show that the adjusted formulation of BupiZenge™ is clean. Stability studies will now continue as planned. The company asserts that a clean and stable product formulation has great commercial value for potential licensees and strategic partners, as a proven, working product is the basis for continued clinical study and an eventual market approval.
As announced in the financial report for the third quarter, the company has for some time analyzed the cause of the previously announced impurity in the lozenge formulation of BupiZengeTM. The root cause has been identified and several options for a minor adjustment in the formulation required to prevent the impurity from occurring have been analyzed. Based on these analyses, the company's new management team decided to resume work on the formulation and several compatibility studies have since been carried out. Today, all three variants of an adjusted formulation have shown positive stability data. No impurities have been detected, fully in accordance with the expectations from the prior analysis. Confidence is further strengthened by the fact that the previous formulation has proven to be clean after four months of stability studies in packaging different than the one used in earlier studies. Taken together, these results from comprehensive analyses clearly delineate the root cause and causality of the previously announced impurity.
Stability studies will now continue according to plan, and the company will update the market as additional data becomes available.
"I am pleased that we have succeeded in identifying the root cause of the impurity in the previous formulation of BupiZenge", says Niclas Holmgren, executive member of the board. "The fact that we have quickly succeeded in identifying solutions proves my thesis that there is great value in OncoZenge. With this achievement, we enable a path to market for BupiZenge, and for reaching the millions of patients in need of oral pain relief."
"Demonstrating a clean and stable product formulation is an important regulatory requirement and a prerequisite for further clinical development and subsequent market approval," says Stian Kildal, CEO of OnzoZenge. “With these facts in hand, we can now confidently continue our conversations with potential licensees and strategic partners towards the commercialization of BupiZenge in Europe, the US and other markets.”
Daniel Ehrenstråhle, chairman of the board, adds “I am pleased that we can confirm this important step in the development of BupiZenge already now thanks to our strong in-house competence and competent CRO partner. Our focus now lies on developing the opportunities to commercialize our product.”
"This is an important milestone on the way forward towards offering a superior treatment option for the millions of people who suffer from oral mucositis and today lack effective, safe and well-tolerated treatment options", Christoph Nowak, trained physician and board member of OncoZenge, concludes.
For additional information, please contact:
Stian Kildal, CEO, mobile +46 76 115 3797, e-mail: stian.kildal@oncozenge.se
Niclas Holmgren, board member, telefon +46 704 22 53 84, e-mail: niclas.holmgren@oncozenge.se
Certified Adviser
OncoZenge's Certified Adviser is Erik Penser Bank AB, Box 7405, 103 91 Stockholm, Sweden
Phone: +46-084638000, e-mail: certifiedadviser@penser.se.
About this information
OncoZenge publishes this information in accordance with the EU Market Abuse Regulation (MAR). The information was submitted for publication on 21 November 2023 at 14:40 CEST through the contact persons above.
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 has its headquarters in Stockholm, Sweden, and its share is publicly traded on Nasdaq First North Growth Market under the ticker ONCOZ.