The Kulakov National Medical Research Centre for Obstetrics, Gynaecology and Perinatology has received approval from Russia’s Health Ministry to conduct a Phase I/II clinical trial of the drug Anti‑NEC‑1. The product is intended to prevent necrotising enterocolitis (NEC) – one of the most severe complications in premature newborns, which carries a high risk of death.
According to the state medicines registry, the Kulakov Centre plans to conduct a randomised, partially blinded, multicentre clinical trial, as well as an open‑label phase to assess tolerability and safety in healthy adult volunteers. The trial is expected to be completed by the end of 2026. The study will involve 180 patients and will be carried out at five medical institutions, including the Almazov National Medical Research Centre and Ogarev Mordovia State University.
According to the research centre, Anti-NEC-1 is based on a consortium of four strains of live symbiotic lactobacilli and bifidobacteria with fully sequenced genomes. Its composition has no analogues among registered probiotic drugs, the developers said. The product has already completed preclinical studies, a patent application has been filed, and introduction into clinical practice is planned for 2028‑2029.
In 2025, the Anti‑NEC‑1 project was also among 30 finalists at the Development Fair organised by the Health Ministry and the Medical Technology Transfer Centre.
Necrotising enterocolitis remains one of the greatest threats to very premature infants. The disease is associated with inflammatory damage to the gut and disruptions to the microbiota. If successful, Anti‑NEC‑1 could become Russia’s first probiotic drug for preventing this complication, based on a symbiotic consortium of bacterial strains.
Earlier, the Russian Health Ministry granted permission for a Phase III clinical trial of BCD‑248, an original bispecific antibody drug developed by Russian pharmaceutical company Biocad for the treatment of multiple myeloma.