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Ondine Biomedical Announces Positive Topline Results from Phase 3 Pivotal LANTERN Study

• The trial met its primary efficacy endpoint.
• Nasal photodisinfection in addition to standard of care was associated with an estimated 40% relative reduction in 30-day surgical site infections compared with standard of care alone in the primary analysis.
• No treatment-related serious safety concerns were identified in the topline review.
• 5,188 patients were enrolled across 18 hospitals in the United States and Canada.
• Ondine plans to share detailed results with FDA and engage with the Agency through the pre-New Drug Application process before submitting a formal marketing application.

Ondine Biomedical Inc. (AIM: OBI), a leader in light-activated antimicrobial therapies to prevent hospital infections, today announced positive topline results from its LANTERN pivotal Phase 3 clinical trial evaluating its nasal photodisinfection technology for the prevention of surgical site infections (“SSIs”).

The LANTERN trial was designed to demonstrate whether nasal photodisinfection in addition to standard of care reduced surgical site infections compared to standard of care alone. The primary analysis estimated a 40% relative reduction in 30-day SSIs and met the trial’s prespecified Bayesian criterion for treatment benefit. The safety profile observed in LANTERN was consistent with more than a decade of prior clinical experience with nasal photodisinfection, including more than 250,000 patient treatments performed outside the United States. No treatment-related serious safety concerns were identified in the topline review; these findings remain subject to completion of detailed efficacy, safety, subgroup and other analyses.

LANTERN enrolled a broad population of 5,188 patients undergoing major surgical procedures across 14 hospitals in the United States and 4 in Canada. Hospitals continued their usual standard of care infection-prevention practices, including permitted use of preoperative nasal mupirocin, presurgical antibiotics and other routine measures.

Ondine plans to request a pre-New Drug Application (“pre-NDA”) meeting with the U.S. Food and Drug Administration (“FDA”) to discuss the detailed LANTERN results and the Company’s planned future regulatory submissions. Detailed study findings will also be presented at a major scientific meeting and submitted for publication in one or more peer-reviewed medical journals.

Carolyn Cross, Chief Executive Officer of Ondine Biomedical, said:

“The LANTERN results represent an important milestone for Ondine and for our development programme in surgical site infection prevention. Surgical site infections remain a major cause of avoidable complications following surgery, while increasing antibiotic resistance makes prevention using non-antibiotic approaches increasingly important.

“We are deeply grateful to the patients, investigators, clinical research teams and healthcare professionals at HCA Healthcare Research Institute and at four Canadian hospitals, whose joint participation made this large study possible. Our prior work in Canada and other countries over more than a decade has supported the potential benefits of nasal photodisinfection for patients and healthcare providers, and we look forward to engaging with the FDA through the regulatory process to bring this technology into the United States.”