Ondine Biomedical's Phase 3 LANTERN trial met its primary efficacy endpoint, with Bayesian analysis estimating a 40.5% reduction in 30-day surgical site infections across 5,188 patients at 18 US and Canadian hospitals. The primary analysis showed a 98.2% posterior probability of benefit and a risk ratio of 0.60, with no treatment-related significant adverse events. Shares rose 5% to 11.50p as the company prepares to request a pre-NDA meeting with the US FDA.
Ondine Biomedical Inc. (AIM:OBI, OTC:OBIMF) reported a 40.5% estimated drop in surgical site infections within 30 days of surgery, after its Phase 3 LANTERN study cleared the prespecified primary efficacy bar.
The primary Bayesian analysis put the posterior probability of treatment benefit at 98.2%, with a risk ratio of 0.60 and a 95% credible interval of 0.33 to 0.97, the Vancouver-based company said in a statement. The trial enrolled 5,188 surgical patients across 18 hospitals in the United States and Canada in a group-randomized, standard-of-care-controlled crossover design.
"Nasal antibiotic mupirocin requires five days of administration before surgery, which creates practical challenges for patients following the regimen," Chief Executive Officer Carolyn Cross said. Ondine's light-activated nasal disinfection is administered by healthcare professionals shortly before surgery, a workflow the company says fits inside existing hospital practice.
Three exploratory frequentist analyses supported the primary result, producing odds ratios of 0.47 to 0.48 with p-values between 0.016 and 0.022 and 95% confidence intervals of 0.25 to 0.88. An odds ratio of 0.47 means patients treated with photodisinfection had roughly 53% lower odds of developing an infection than those on standard care. No treatment-related significant adverse events were reported during the trial.
Shares rose 5% to 11.50p in London trading, against a market capitalization of £58.32 million. The stock carries a Sell technical sentiment signal, with average trading volume of 478,985 shares.
The comparator arm permitted mupirocin, the nasal antibiotic that has been the standard preoperative decolonisation tool for decades. Ondine's platform uses a light-activated antimicrobial applied to the nasal reservoir of pathogens, a non-antibiotic approach the company frames around antimicrobial stewardship as resistance concerns mount.
Ondine said it will request a pre-New Drug Application meeting with the U.S. Food and Drug Administration to review the detailed LANTERN results and discuss planned regulatory submissions. The therapy remains investigational and is not approved for commercial use in the United States. Steriwave, the company's lead product, is authorised for nasal decolonisation in Canada, the UK and other markets.
Analysis of the complete dataset is ongoing, covering secondary and exploratory endpoints. Ondine said it will present detailed findings at a scientific meeting and submit them for publication in peer-reviewed medical journals, and hosted an investor presentation at 16:30 BST on Wednesday.
The addressable market is large: more than 35 million major surgeries are performed annually in the United States alone, where surgical site infections add billions of dollars in healthcare costs and raise mortality risk. Ondine is also developing photodisinfection treatments for chronic sinusitis, ventilator-associated pneumonia and burns.
For holders, the readout shifts the story from clinical risk to execution risk — the binary event that has capped the stock is now resolved in the company's favour, and the next test is whether the FDA accepts the LANTERN package. Investors will watch for the pre-NDA meeting outcome and the full secondary-endpoint dataset, neither of which has a disclosed date. TipRanks' AI Analyst rates OBI Neutral, held back by large losses, declining gross margin and worsening cash burn despite solid revenue growth.
This article is for informational purposes only and does not constitute investment advice.
