Radical Numerics says a patient with an antibiotic-resistant E. coli infection received phages designed by its Omnii-1 model, an event the company calls the first clinical use of AI-designed phages. It has not said whether the treatment helped the patient.
The company’s Oct. 20 research preview says laboratory testing found that the cocktail eliminated the patient’s bacterial isolate in vitro, or outside the body. That result does not establish how the patient responded after administration. Radical Numerics says it is withholding details of the patient’s clinical course for privacy reasons.
In a separate description of the case, Radical Numerics identifies the infection as E. coli and says the cocktail included T7 phage variants. The company says treatment took place under a single-patient Investigational New Drug application authorized by the U.S. Food and Drug Administration (FDA), through expanded access, also called compassionate use. The research preview describes an authorized physician-led compassionate-use pathway but does not name the bacterium or regulator.
The FDA says expanded access can let patients with serious or immediately life-threatening conditions receive investigational products outside clinical trials when no comparable or satisfactory treatment is available. The specific authorization for this case is described by Radical Numerics.
Omnii-1 is a multimodal genome language model that Radical Numerics says can generate phage variants, rank candidates and predict interactions between phages and bacteria. In a separate company-reported lab experiment, 69.9% of designed variants with 11 to 15 amino-acid changes from wild type were recovered, compared with 4.8% of random controls. The company uses recovery as a proxy for viability; the measure does not establish that a variant would benefit a patient.
Personalized phage therapy often involves testing a patient’s bacterial sample against collections of phages, Radical Numerics says, with engineering considered when no suitable candidate is found. Phages infect bacteria rather than human cells, according to the World Health Organization (WHO), but their specificity means a treatment must match the bacteria causing an infection. WHO says phage therapy has been used for more than 100 years in parts of Eastern Europe and that further clinical evidence is needed before wider use in people.
Radical Numerics says its investigational therapy is not approved for broader clinical use and that one patient’s experience cannot establish safety or effectiveness. The company has not announced a date for another clinical update.
