Results of the ORBEX study

The ORBEX investigator-initiated study (IIS), recently published in The Lancet, led by Professor Fernando Martinez of the University of Arizona, an internationally recognized expert in pediatric asthma, explored whether early intervention with OM-85 could help prevent the development of asthma before clinical disease onset. Thus, the study evaluated OM-85 in a new population and a new, unapproved indication focused on primary prevention, distinct from its approved use in the prevention of recurrent respiratory tract infections (RTIs). OM-85 is a bacterial lysate approved in 69 countries for the prevention of recurrent RTIs. The study did not demonstrate efficacy in preventing the onset of asthma or wheezing in the population evaluated. Importantly, ORBEX confirmed the favourable safety profile of OM-85 in very young children, including during prolonged administration over a two-year period. These findings further improve our understanding of the potential role of bacterial lysates in early immune development. As the study addressed a highly innovative and exploratory scientific question, its findings do not affect our current understanding of OM-85 in its approved indication or our current development plans for OM-85, including its US development programme. OM Pharma remains focused on its core mission of improving outcomes for patients at risk of recurrent respiratory tract infections through the evidence-based use of OM-85. Recent REACH results further support the current use of OM-85 by showing continued benefits for patients in real-world clinical practice, reinforcing our confidence in its value in infection prevention.

The release as fetched from its publisher. ompharma.com ↗