The Connection study is the first ever regulatory medicines agency approved phase 3 study on the potential benefits of any pharmaceutical grade live bacterial therapy in premature infants. IBT is following the strict regulations of worldwide medicines regulatory authorities in developing the medical drug candidate IBP-9414 as a preventive treatment for NEC in premature infants.
After years of development of the product formulation for IBP-9414 and its production to meet the demands of FDA and EMA, a Phase 2 safety and tolerability clinical study of 120 premature babies (results summary is here) has been completed. This study provided the important demonstration to the FDA and EMA of the satisfactory safety characteristics of IBP-9414 in preterm infants. Based on this and the approved drug development plan, IBP-9414 was granted progression into large scale, benefit-risk analysis in premature babies with 500-1500 gram birth weights, through the Phase 3 drug trial, called the ‘Connection Study’.
The ongoing Connection Study forms the final part of this drug development program and aims at generating the necessary knowledge on the ability of IBP-9414 to prevent NEC, and improve feeding of premature infants. The study is designed to have minimal interference with regular standards of intensive care and minimized extra burden on the health care personnel. It is the Phase 3 large efficacy and safety clinical trial required to allow filing for approval of IBP-9414 for the treatment of premature infants.
Name of Medical Product: IBP-9414 (active Ingredient: Lactobacillus reuteri)
Number of Subjects: 2158
Study Title: A randomized, double blind, parallel-group, placebo-controlled study to evaluate the efficacy and safety of IBP-9414 in premature infants 500-1500g birth weight in the prevention of necrotizing enterocolitis – The Connection Study.
Study Duration: Screening and Randomization visit is within 48 hours after birth of the subject. First dose of Investigational Product will be administered ≤48 hours after birth and continued daily until the subject reaches 34 weeks + 6 days Post-Menstrual Age (PMA), or until treatment is permanently discontinued if earlier. A follow-up assessment will be made at 40 weeks ± 7 days PMA.
Study Objectives: Primary Objective: To evaluate the efficacy of IBP-9414 vs. placebo on the prevention of necrotizing enterocolitis and on sustained feeding tolerance in very low birth weight premature infants, as well as the safety of IBP- 9414 vs. placebo.
Secondary Objectives: To evaluate the effect of IBP-9414 on different severities of NEC, all cause mortality, duration of hospitalization, growth and feeding tolerance in very low birth weight premature infants.
Patient Population: Preterm infants with a birth weight of 500-1500g, and a gestational age of 23 weeks+0 days – 32 weeks+0 days at birth.
Current Status: The Connection study currently is recruiting premature infants with a birth weight of 500- 1,000 grams. This pivotal phase III study investigates the safety characteristics and the effectiveness of IBP-9414 over placebo in the prevention of NEC in preterm infants with a birth weight of 500-1,500 g. In accordance with the clinical study protocol of IBP-9414-020, the independent Data Monitoring Committee (DMC) has reviewed treatment- unblinded data from the first 300 infants followed by such review for the first 600 infants in the 500-1000g birth weight interval. They recommended continuation of the study based on the safety and tolerability profile of IBP-9414 and that the predefined futility stopping criterion not had been met.
More information can be found at ClinicalTrials.gov Identifier: NCT03978000